Commission staff working paper accompanying the proposal for a directive of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) - Impact Assessment {COM(2008) 809 final} {SEC(2008) 2931}
Date: 2008-12-03
Institutions: European Commission
Subjects: EU law, dangerous substance, electrical equipment, electronic equipment, operation of the Institutions, public health, waste management, waste recycling

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 3.12.2008 
SEC2008) 2930 

COMMISSION STAFF WORKING PAPER 

accompanying the 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the restriction of the use of certain hazardous substances in electrical and electronic 
equipment 

(recast) 

Impact Assessment 

{COM(2008) 809 final} 
{SEC(2008) 2931} 

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TABLE OF CONTENTS 

EXECUTIVE SUMMARY........................................................................................................ 5 

INTRODUCTION...................................................................................................................... 9 

1. 

1.1. 

1.2. 

2. 

2.1. 

2.2. 

Procedural issues and consultation of interested parties ............................................ 12 

Organisation and timing............................................................................................. 12 

Consultation and expertise ......................................................................................... 12 

Problem Definition..................................................................................................... 15 

Problems requiring action .......................................................................................... 15 

Underlying drivers of the problems ........................................................................... 18 

2.3.  Who is affected, in what ways, and to what extent? .................................................. 19 

2.4. 

2.5. 

3. 

How would the problem evolve, if no action is taken................................................ 19 

The EU right to act..................................................................................................... 22 

Objectives................................................................................................................... 22 

3.1. 

Objectives of the review............................................................................................. 22 

3.2. 

Consistency of these objectives with other EU policies ............................................ 23 

4. 

Description of Policy Options.................................................................................... 24 

4.1. 

Options to clarify and simplify the Directive............................................................. 24 

4.1.1.  Make no changes to scope or definitions ................................................................... 24 

4.1.2.  Create an independent scope for RoHS ..................................................................... 24 

4.1.3.  Clarification on spare parts ........................................................................................ 24 

4.1.4.  Clarification on excluded equipment ......................................................................... 25 

4.1.5.  Adding/modifying definitions.................................................................................... 25 

4.2. 

Options to improve enforcement................................................................................ 25 

4.2.1.  Make no changes: not add provisions aiming at better enforcement ......................... 25 

4.2.2.  Strengthen mechanisms to remove non-compliant products from the market........... 25 

4.2.3.  Harmonize methods for demonstrating compliance .................................................. 25 

4.3. 

Options to adapt the Directive to technical and scientific progress ........................... 26 

4.3.1.  Exemptions................................................................................................................. 26 

4.3.1.1.  Make no changes to the exemption mechanism......................................................... 26 

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4.3.1.2.  Remove the exemption mechanism from the Directive............................................. 26 

4.3.1.3.  Maintain the exemptions procedure with changes in the criteria for granting and 

withdrawing exemptions ............................................................................................ 26 

4.3.2.  Adapt product coverage to technical and scientific progress..................................... 26 

4.3.2.1.  Remove all products from scope of RoHS – repeal RoHS ........................................ 26 

4.3.2.2.  Make no changes, not include categories 8 and 9...................................................... 27 

4.3.2.3.  Include all of Categories 8 and 9 with specific exemptions: ..................................... 27 

4.3.3.  Substances covered [article 6 of RoHS]..................................................................... 27 

4.3.3.1.  Make no changes to the list of substances regulated by RoHS.................................. 28 

4.3.3.2.  Remove substances from the list of banned substances under RoHS........................ 28 

4.3.3.3.  Add new substances for all EEE, in the scope of RoHS but with exempted 

applications ................................................................................................................ 28 

5. 

Analysis of impacts .................................................................................................... 28 

5.1. 

Options to clarify and simplify the Directive............................................................. 29 

5.1.1.  Make no changes to scope and definitions................................................................. 29 

5.1.2.  Create an independent scope for RoHS ..................................................................... 29 

5.1.3.  Clarification on spare parts ........................................................................................ 30 

5.1.4.  Clarification on excluded equipment ......................................................................... 31 

5.1.5.  Adding/modifying definitions.................................................................................... 32 

5.2. 

Options to improve enforcement................................................................................ 33 

5.2.1.  Make no changes: not add provisions aiming at better implementation and 

enforcement................................................................................................................ 33 

5.2.2.  Strengthen mechanisms to remove non-compliant products from the market........... 33 

5.2.3.  Harmonize methods for demonstrating compliance .................................................. 34 

5.3. 

Options to adapt the Directive to technical and scientific progress ........................... 36 

5.3.1.  Exemptions................................................................................................................. 36 

5.3.1.1.  Make no changes to the exemption mechanism......................................................... 36 

5.3.1.2.  Remove the exemption mechanism from the Directive............................................. 37 

5.3.1.3.  Maintain the exemptions procedure with changes in the criteria for granting and 

withdrawing exemptions and in the procedure for granting exemptions................... 38 

5.3.2.  Adapt product coverage to technical and scientific progress..................................... 39 

5.3.2.1.  Remove all products from scope of ROHS – repeal ROHS ...................................... 39 

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5.3.2.2.  Make no changes, not include categories 8 and 9...................................................... 41 

5.3.2.3.  Include all of Categories 8 and 9 with specific exemptions: ..................................... 41 

5.3.3.  Substances covered [article 6 of RoHS]..................................................................... 46 

5.3.3.1.  Make no changes to the list of substances regulated by RoHS.................................. 46 

5.3.3.2.  Remove substances from the list of banned substances under RoHS........................ 47 

5.3.3.3.  Add new substances for all EEE, in the scope of RoHS but with exempted 

applications ................................................................................................................ 48 

6. 

6.1. 

6.2. 

6.3. 

Comparing the options ............................................................................................... 50 

Options to clarify and simplify the Directive............................................................. 50 

Options to improve enforcement................................................................................ 51 

Options to adapt the Directive to technical and scientific progress ........................... 53 

6.3.1.  Exemptions................................................................................................................. 53 

6.3.2.  Adapt product coverage to technical and scientific progress..................................... 54 

6.3.3.  Substances covered [article 6 of RoHS]..................................................................... 56 

6.4. 

Overall benefits and costs from the recommended options ....................................... 57 

7. 

7.1. 

7.2. 

Monitoring and evaluation ......................................................................................... 58 

Core indicators of progress towards meeting the objectives...................................... 58 

Broad outline for possible monitoring and evaluation arrangements ........................ 59 

ANNEX I.................................................................................................................................. 60 

ANNEX II ................................................................................................................................ 63 

ANNEX III............................................................................................................................... 65 

ANNEX IV............................................................................................................................... 67 

GLOSSARY............................................................................................................................. 72

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COMMISSION STAFF WORKING PAPER 

Impact Assessment for a Commission Proposal on the review of Directive 2002/95/EC on 
the restriction of the use of certain hazardous substances in electrical and electronic 
equipment 

EXECUTIVE SUMMARY 

RATIONALE FOR THE REVIEW 

Directive  2002/95/EC  aims  to  restrict  hazardous  substances  in  electrical  and  electronic 
equipment  so  as  to  contribute  to  the  protection  of  human  health  and  the  environmentally 
sound recovery and disposal of waste electrical and electronic equipment. Its review is being 
carried out for two main reasons: 

1. The Commission is committed to developing a better regulatory environment, one that is 
simple,  understandable,  effective  and  enforceable.  The  regulatory  environment  in  which 
businesses operate influences their competitiveness, and their ability to grow and create jobs. 
The aim for better regulation is an important element in the EU’s Partnership for Growth and 
Jobs  (Lisbon)  strategy.  There  is  room  to  improve  the  Directive  in  terms  of  implementation, 
enforcement and coherence. 

2. The RoHS Directive calls on the Commission to review the measures provided for in the 
Directive in particular with regard to the inclusion of two additional categories of equipment 
in the scope (categories 8&9 : medical devices and monitoring and control instruments) and 
the adaptation of the list of restricted substances. 

PROBLEM AND OBJECTIVES  

Achievement  of  the  RoHS  Directive’s  objectives  is  hindered  and  made  more  costly  by 
problems  related  to  uncertainties  in  implementation  such  as  lack  of  harmonisation  in 
interpretation  of  definitions  and  diverging  requirements  for  demonstration  of  product 
compliance;  problems  with  enforcement  such  as  suboptimal  market  surveillance  activities; 
and  problems  related  to  perceived  inconsistency  with  other  Community  legislation  or 
technical/scientific  progress,  such  as  potential  overlaps  with  REACH  or  EuP  and  need  for 
extending the scope to cover medical devices and control and monitoring instruments. .  

The objectives of the review are: improved implementation and enforcement of the Directive, 
enhanced  consistency  with  related  Community  product  legislation,  improvements  in  cost 
effectiveness of the Directive and increased environmental benefit. 

THE REVIEW PROCESS 

Two  stakeholder  consultations  and  several  studies  were  carried  out.  These  dealt  with  the 
topics of the review as well as the policy options within each topic. These consultations and 
studies helped define and analyse a number of specific options as outlined below. 

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OPTIONS 

The options are grouped in three main classes: 

1. Clarify and simplify the Directive 

2. Improve enforcement at national level 

3. Adapt the Directive to technical and scientific progress 

Within each of these main groupings a number of options were considered and an analysis of 
costs and benefits was carried out for each option. 

A  common  feature  of  both  consultations  and  studies  launched  by  the  Commission  services 
was  the  difficult  access  to  quantitative  data.  Possible  reasons  include  the  inability  of 
stakeholders  to  provide  data  and  information  and  the  fact  that  the  Directive  is  quite  young 
(entry into force of the ban in July 2006, enforcement activities started in 2007) as well as the 
absence of formalized compliance/reporting mechanisms. 

SELECTED OPTIONS 

In summary, the following options are recommended: 

Changes in the legal text to clarify scope and definitions, in particular by creating a list of 
products defining the scope of the RoHS Directive which is binding and not dependent on the 
scope of the WEEE Directive 

Introduction  of  all  relevant  provisions  already  used  in  the  EU  "Marketing  of  products” 
package of legislation concerning: 

– 

– 

– 

national market surveillance activities; 

mechanisms for assessing the conformity of the product prior to its placing on 
the market based on the self declaration by the producer; 

presumption of conformity of the product on the basis of harmonised standards 
and CE marking. 

Adaptation of the procedure for exemptions, for instance by introducing through comitology 
a  requirement  for  applicants  to  analyse  the  substitutes  before  submitting  a  request,  and  the 
introduction of additional criteria for granting an exemption;  

Inclusion  in  a  staged  manner  in  the  scope  of  RoHS  of  medical  devices  and  control  and 
monitoring instruments; no changes in the list of restricted substances. 

BENFITS and COSTS 

An overview of the costs and benefits of these options is as follows: 

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•  There  is  little  experience  of  actual  compliance  costs  in  industry;  for  products  currently 
included in RoHS estimates are it would vary from 1-4% of turnover. More recent surveys 
give  an  average  overall  cost  related  to  RoHS  of  1,9%  of  turnover  (past  cost  and  one-off 
future costs).  

In  the  case  of  medical  devices  and  control  and  monitoring  instruments  some  of  which  are 
produced  in  low  numbers  or  have  critical  applications  and  hence  increased  testing  and 
reliability requirements, approximate yearly compliance cost is estimated to 400-1600 million 
€; it is even claimed that co st of RoHS compliance for some complex products could be as 
high as 7-10% of turnover (new product) or 1-10% (modification of existing product). A large 
part  of  this  cost  is  attributable  to  the  long  development,  testing  and  approval  cycles  of  the 
more  complex  products.  This  is  why  a  staged  introduction  for  these  products  is  proposed 
allowing the compliance conversion to take place in the framework of existing resources and 
product development cycles. 

The  RoHS  Directive  does  not  foresee  explicit  reporting  obligations  for  Member  States  or 
information supply requirements by manufacturers and in most cases Member States have not 
introduced  such  legal  obligations  at  national  level.  The  process  for  granting  exemptions  is 
considered  lengthy  for  products  with  short  innovation  cycles;  harmonising  the  requirements 
for  the  contents  of  the  application  and  clarifying  the  period  of  validity  of  exemptions  will 
speed  up  the  process,  increase  legal  security  and  reduce  administrative  burden  for  both 
authorities and the applicants.  

The  introduction  of  harmonised  requirements  for  scope,  definitions,  assessment  of  product 
conformity  and  market  surveillance  which  are  in  line  with  other  product-related  EU  legal 
requirements will increase legal certainty and thus reduce the administrative burden.  

Initial  implementation  of  these  revised  provisions  could  create  additional  administrative 
burden for Member States and producers dependent on the Member State’s current level of 
preparation for proper enforcement and on the adequacy of measures taken by producers for 
ensuring product compliance.  

The  Commission  services  estimate  that  overall  net  benefits,  albeit  modest,  will  ensue. 
Moreover,  the  recommended  options  will  have  an  important  cumulative  effect  in  clarifying 
the  Directive  and  harmonising  its  implementation  and  enforcement  with  a  positive 
contribution to better regulation. 

Environmental  benefits  are  likely  to  be  significant:  several  tonnes  of  the  heavy  metals 
banned under RoHS (>1400 tonnes of lead, approximately 2,2 tonnes of cadmium) are used in 
medical devices and control and monitoring instruments, which account for 0,2-03% of waste 
from  electrical  and  electronic  equipment  by  weight;  these  substances  by  improper  waste 
management may be released to the environment (only 49,7% of waste medical devices and 
65,2%  of  waste  control  and  monitoring  instruments  are  separately  collected);  restricting  the 
use  of  these  substances  through  RoHS  will  in  the  medium  to  long  term  eliminate  their 
presence  in  the  products  and  in  the  waste  thereof;  further  analysis  shows  that  even  in 
scenarios  assuming  much  higher  recycling  rates  there  is  some  environmental  benefit  from 
including these categories of equipment in the scope of RoHS. 

Taking  into  account  that  current  Member  States  checks  revealed  that  up  to  44%  of  EEE 
checked were not fully compliant, effective market surveillance mechanisms at national level 
and  enhanced  cooperation  among  Member  State  authorities  for  removal  of  non-compliant 

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products  are  expected  to  increase  considerably  the  environmental  benefit  of  RoHS  by 
minimising the number of non-compliant products on the market.  

Concerning the adaptation of list of hazardous substances regulated by RoHS, the preparatory 
studies  identified  candidate  substances,  but  given  the  lack  of  sufficient  information  on 
substitutes, which does not allow a clear view on whether they are environmentally safer or, 
in  cases  where  environmentally  safer  alternatives  do  exist,  whether  replacement  costs  are 
proportionate  to  environmental  benefits,  it  is  not  considered  feasible  to  propose  new 
hazardous substances in the scope of RoHS. 

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INTRODUCTION 

Background 

Electric and electronic equipment (EEE) is a product group characterized by extreme diversity 
and  increasingly  fast  innovation  cycles.  Its  production  supports  one  of  the  fastest  growing 
domains  of  manufacturing  industry  in  the  western  world.  In  the  EU  alone  an  estimated  9,3 
million  tonnes  of  EEE  are  sold  annually,  the  biggest  share  of  which  are  large  household 
appliances and IT and telecommunication equipment. 

As  the  market  continues  to  expand  and  innovation  cycles  become  even  shorter,  the 
replacement  of  equipment  accelerates,  making  waste  electrical  and  electronic  equipment 
(WEEE) the fastest growing waste stream. WEEE arisings are estimated to be 14-24 kg/head 
for EU 15 Member States and 6-12 kg/head in the new Member States. This is estimated to 
total 8,3 to 9,1 million tonnes per year, growing to 12,3 million tonnes by 2020. 

WEEE  is  a  complex  waste  stream  of  different  materials  and  components,  including  several 
hazardous substances that can be released into the environment and damage human health if 
not treated appropriately. Potential risks for the environmental and human health are further 
increased by sub-standard recycling/recovery operations in developing countries, driven by a 
rising demand for raw materials and often supplied by illegal shipments of WEEE1. 

These risks can be significantly reduced by sound management of WEEE. Elements of sound 
management include: separating WEEE from other waste to facilitate targeted and technically 
adequate  treatment,  applying  treatment  standards  that  minimize  the  release  of  harmful 
substances and recovering as much as feasible materials and energy embodied in the waste. 
These measures can be complemented by innovative design of EEE. This can help to avoid to 
the extent possible the use of hazardous substances, reduce possible exposure of workers and 
consumers, and favour the efficient dismantling and sorting of waste. 

In  principle,  such  an  approach  offers  opportunities  for  the  waste  management  sector, 
equipment  manufacturers  and  producers  of  EEE  (first  mover  advantage).  However, 
historically  market  forces  alone  have  not  been  strong  enough  to  promote  significant 
improvements  to  the  management  of  WEEE  –  as  recently  as  the  1990s  more  than  90%  of 
WEEE was still landfilled, incinerated or recovered without pre-treatment. Some of the main 
reasons seem to include: 

– 

– 

1 

The  high  number  of  EEE  manufacturers  on  the  (global)  market  makes  voluntary 
design  changes  in  the  interest  of  recycling  unlikely  as  it  may  entail  extra  cost  and 
benefits often cannot be linked to individual producers; 

Hazardous substances are often the cheapest technical solutions in the short term; 

Environment  and  human  health  concerns  in  the  processing  of  electrical  and  electronic  waste, 
Greenpeace  Research  Laboratories,  University  of  Exeter,  Technical  note  04/2006,  May  2006;  "High-
Tech Trash" by C.Caroll, National Geographic, published January 2008; The recycling and disposal of 
electrical  and  electronic  waste  in  China  –  legislative  and  market  responses,  Environmental  Impact 
Assessment  review  25  (2005),  p.461,  462;  Heavy  metals  concentrations  of  surface  dust  from  e-waste 
recycling and its human Health implications in Southeast China, Anna W.Leung et al, January 2008.  

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– 

– 

Inadequate disposal of WEEE has no extra costs or may even have price incentives 
(low-cost landfilling in many countries; illegal exports for sub-standard treatment); 

Low  prices  for  raw  materials  in  previous  decades  discouraged  investment  in 
collection and recycling infrastructure. Even the present raw materials prices enable 
profitable  operations  in  the  EU  for  only  few  waste  materials  and  fears  of  cyclical 
price changes keep holding back investment. 

In  reaction  to  this,  in  the  late  1990s  several  Member  States  introduced  national  laws  to 
address  environmental  concerns  related  to  the  management  of  WEEE.  In  2000,  the 
Commission proposed EU legislation in this field, in response to rapidly growing amounts of 
WEEE  and  associated  possible  environmental  and  health  problems,  and  to  approximate 
product-related  legislation  across  Member  States.  As  a  result,  the  WEEE  and  RoHS 
Directives2 were adopted in 2002. 

Objectives and rationale of the WEEE and RoHS Directives 

The  WEEE  Directive  aims  to  prevent  WEEE,  and  where  this  is  not  possible  to  recycle  and 
recover  it  to  reduce  its  disposal.  It  requires  Member  States  to  ensure  that  collection  and 
treatment  schemes  are  set  up,  sets  collection  and  recovery  targets,  and  makes  producers3 
responsible  for  the  financing  of  the  WEEE  management.  So  far,  no  negative  effects  on 
consumption  levels  have  been  reported  although,  during  a  transitional  period,  the  costs  of 
collection and treatment are clearly indicated on new equipment. The Directive thus enables 
market  mechanisms  and  financial  incentives  in  favour  of  efficient  collection,  treatment  and 
“design for recycling”. 

The RoHS Directive prohibits the use of certain hazardous substances in EEE, approximating 
national  legislation  across  Member  States  to  ensure  the  free  movement  of  goods.  Its 
environmental objective is to protect humans and the environment against the release of these 
substances  and  to  facilitate  recycling  and  recovery  of  materials  from  WEEE.  While 
establishing  binding  minimum  requirements  for  all  producers,  it  enables  competitive 
advantages for innovative products and technologies that can comply with the substance ban 
more efficiently. 

Recent  research  has  confirmed  the  rationale  of  the  Directives4.  For  example,  the  total 
prevented  global  warming  potential  by  treating  waste  fridges  is  more  than  2000  kg  CO2 
equivalent  per  fridge  and  energy  savings  from  recycling  metals  contained  in  WEEE  can  be 
significant;  recycled  copper  requires  85%  less  energy  and  recycled  steel  requires  74%  less 
energy than the extraction and refining of virgin materials. 

While  the  RoHS  Directive  contributes  effectively  to  reducing  hazardous  substances  in  new 
EEE, hazardous substances such as mercury, cadmium, lead, hexavalent chromium PBBs and 
PBDEs will still be present in WEEE for many years. Reasons are, among others, waste from 
"pre-RoHS" equipment, exemptions under the RoHS Directive and non-compliant equipment 
placed  on  the  market  illegally.  Separation,  recovery  and  treatment  of  WEEE  will  therefore 
remain necessary for the foreseeable future. 

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Directives 2002/96/EC and 2002/95/EC respectively 
“Producers” are manufacturers of EEE in the EU as well as first-time importers of EEE into the EU. 
UNU study 

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Experience with implementing the Directives 

Both Directives had to be transposed by the Member States by 13 August 2004. By 13 August 
2005, collection and treatment systems needed to be in place and producers of electrical and 
electronic  equipment  needed  to  start  providing  for  their  financing.  The  collection  and 
recovery targets needed to be achieved by 31 December 2006 and the substance ban entered 
into force on 1 July 2006. Practical experience with implementing the Directives is therefore 
still building up but significant results have already been achieved: 

– 

– 

Compared to the 1990s, in 2005 about 2 million tonnes of WEEE have been diverted 
from  disposal  without  any  pre-treatment,  by  separate  collection  followed  by 
treatment operations 

The RoHS Directive has resulted in reducing the quantities of the banned substances 
being disposed of and potentially released into the environment by 89800 tonnes of 
lead,  4300  tonnes  of  cadmium,  537  tonnes  of  hexavalent  chromium,  22  tonnes  of 
mercury and 12600 tonnes of Octa-BDE5. 

Significant investments were made in treatment facilities (15 new facilities in the EU-15 plus 
treatment  facilities  serving  several  new  Member  States  at  the  same  time)  and  the  WEEE 
recycling  business  increased  to  a  multi  billion  industry,  employing  several  ten  thousands  of 
persons.  However,  there  are  indications  that  the  Directives  are  not  yet  achieving  their 
objectives as efficiently as possible. Some of the main reasons for this are unclarity or lack of 
definitions,  resulting  in  legal  uncertainty  or  sub-optimal  solutions  at  national  levels. 
Furthermore,  there  is  now  sufficient  experience  and  knowledge  to  design  more  effective 
collection and recycling/recovery targets, streamline the process of granting exemptions under 
the RoHS Directive and efficiently widen the scope of the RoHS Directive to strengthen its 
environmental benefits. 

Issues for Review 

The  Directives  themselves  call  for  a  review  of  certain  provisions,  notably  the  list  of 
substances banned under RoHS, the list of equipment covered by the substance ban (possible 
inclusion of control and monitoring and medical equipment), and the collection and recycling 
targets for 2008, with the aim of adapting the provisions to scientific evidence as well as to 
technical and economic experience in the Member States.6 

Furthermore,  a  review  of  the  Directives  is  foreseen  by  the  Commission's  simplification 
strategy, which should contribute to better implementation and enforcement of the Directives 
at national level. 

Also based on the experience with implementation and enforcement of the two Directives at 
national level the following issues appear to request particular attention: Clarifying the scope, 
reviewing the substance ban, streamlining procedures, strengthening collection and recycling 
targets  (WEEE),  improving  enforcement,  clarifying  definitions  and  clarifying  relations 
between the two directives and with other relevant Community legislation.  

5 
6 

Arcadis report (See Annex I) 
See Articles Articles 4(3) and 6 of the RoHS Directive and Articles 5(5), 7 (4) and 17 (5) of the WEEE 
Directive. 

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1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

1.1. 

Organisation and timing 

The  elaboration  of  policy  options  started  after  the  end  of  the  first  stakeholder  consultation 
identifying  topics  for  the  review  of  the  Directive  on  the  restriction  of  the  use  of  certain 
hazardous  substances  in  electrical  and  electronic  equipment  (RoHS)  (late  spring  2007); 
following  the  conclusion  of  the  second  consultation  on  policy  options  (February  2008) 
drafting of the Impact Assessment started in spring 2008. 

An  Inter-Service  group  on  the  review  of  the  two  related  WEEE  and  RoHS  Directives  was 
created  in  early  2007;  it  was  regularly  informed  on  and  provided  input  to  all  important 
milestones  of  the  review  (preparation  of  study  reports,  stakeholder  consultations);  in 
particular  during  2007  it  was  extensively  consulted  and  provided  comments  on  the 
background documents for the two stakeholder consultations on the RoHS Directive review. It 
was also convened in May 2008 to discuss the policy options to be presented in the impact 
assessment. 

1.2. 

Consultation and expertise 

•  Studies 

A comprehensive study (referred to below as the "ERA report") regarding the possibility of 
including  medical  devices  monitoring  and  control  instruments,  as  requested  by  Article  6  of 
RoHS, was carried out in 20067. 

A study8 (Ökoinstitut) examining the need and feasibility of regulating under RoHS additional 
hazardous substances (HS) used in electrical and electronic equipment (EEE) as required by 
Articles 4(3) and 6 of RoHS Directive. 

A service contract related to adaptation to scientific and technical progress of RoHS, aiming 
primarily  at  reviewing  existing  exemptions  granted  in  its  current  annex  is  underway 
(finalisation foreseen end November 2008). 

A service contract (BIO Intelligence) to assist the Commission services with technical aspects 
of the impact assessment was finalized in July 2008. 

A  study  focusing  on  innovation  and  competition  aspects  of  the  WEEE  and  RoHS  review 
("Arcadis study")9. 

In  the  context  of  the  WEEE  Directive  review,  two  studies10  have  been  executed  which  are 
relevant for the RoHS review as well, in particular with regard to the scope, the definitions, 
the EEE quantities and composition (content in HS and materials) the separate collection of 
WEEE as well as the structure of the EEE markets and development of cost/prices. 

7 
8 
9 
10 

http://ec.europa.eu/environment/waste/pdf/era_study_final_report.pdf. 
http://hse-rohs.oeko.info/. 
http://ec.europa.eu/enterprise/environment/reports_studies/index.htm 
http://ec.europa.eu/environment/waste/pdf/weee_review.pdf 

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Furthermore, the relevant information from the preparatory studies carried out under the Eco-
design framework Directive (EuP) has been considered where relevant. 

•  Stakeholder consultations 

Two structured stakeholder consultations have been launched via the EUROPA website, one 
inviting  comments  on  topics  and  for  information  supply  for  the  RoHS  Directive  review  in 
March-May  2007  and  a  second  for  receiving  feedback  and  information  on  proposed  policy 
options during winter 2007 (December – February 2008). 

Apart  from  this  there  were  regular  contacts  with  industry  (in  particular  the  industry 
associations  for  medical  devices,  control  and  monitoring  instruments)  and  NGOs.  The 
Member States representatives were frequently updated during the meetings of the Regulatory 
Committee and at informal meetings. Technical workshops with stakeholders were held, for 
providing  input  during  critical  stages  of  the  above  mentioned  studies  (for  example  in  July 
2007 and May 2008). 

The responses to the consultations covered a large stakeholder and geographical spectrum and 
there were considerable variations in the extent and quality of the contributions. 

Industry stakeholders focused on the need of streamlined and harmonised implementation (in 
particular  with  regard  to  scope  and  demonstration  of  compliance)  and  speeding  up  the 
exemptions mechanism. NGOs called for enhancing the environmental and health benefits of 
the Directive. 

The preselection of topics' by the Commission services was not fundamentally criticised; few 
additional  topics  were  proposed  which  could  in  most  cases  be  considered  as  more  detailed 
subdivisions of a main topic. This pointed to a comprehensive coverage of the possible topics 
for review in the first consultation document and therefore the Commission services used it as 
a basis for developing the detailed policy options. 

In  the  second  consultation  the  options  were  presented  for  each  topic  highlighting  pros  and 
cons;  stakeholders  were  invited  to  express  their  opinion  on  the  outlined  options,  on  the 
possibility  of  combining  options,  on  ranking  of  options  within  each  topic  and  to  propose 
additional options. They were explicitly asked to provide studies and evaluations which would 
allow to analyse the full costs and benefits of any changes in the Directive. 

In most cases little new factual information was provided. However, stakeholders responded 
extensively,  in  many  cases  on  each  individual  option,  thus  giving  a  clear  idea  as  to  the 
opinions on the individual options and on the future orientations of RoHS in general.  

Some went as far as suggesting phasing out of RoHS and entrusting the hazardous substances 
management  in  REACH,  but  the  vast  majority  of  stakeholders  did  not  share  this  view.  In 
general  stakeholders  submitted  constructive  ideas  for  clarifying  concepts  and  reducing 
uncertainties. 

The  standards  applicable  to  public  consultations  in  terms  of  duration,  transparency, 
acknowledgement of receipt and feedback have been respected. Stakeholders have been pro-
actively  notified  about  launching  of  the  consultations,  given  the  possibility  to  view  all 
relevant non-confidential contributions and informed about the outcome through publication 
of a summary of the comments. 

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Contributions 
http://ec.europa.eu/environment/waste/weee/events_rohs2_en.htm. 

stakeholder 

summary 

comments 

and 

of 

are 

available 

at 

A  common  feature  of  both  consultations  and  studies  launched  by  the  Commission  services 
was  the  difficult  access  to  quantitative  data.  Possible  reasons11  include  the  inability  of 
stakeholders  to  provide  data  and  information  and  the  fact  that  the  Directive  is  quite  young 
(entry into force of the ban in July 2006, enforcement activities started in 2007) as well as the 
absence  of  formalized  compliance/reporting  mechanisms.  Another  important  aspect  is  that 
some  information  on  cost  of  compliance  activities  (for  example  technical  modifications  of 
products,  materials'  use,  internal  organisation)  are  considered  by  some  companies  as  too 
commercially  sensitive  to  be  shared  in  a  stakeholder  consultation  or  a  study  of  the 
Commission services. 

Comments from the Impact Assessment Board 

A  draft  of  this  Impact  Assessment  was  examined  by  the  Impact  Assessment  Board  and 
discussed  during  its  meeting  of  2  July  2008,  after  which  comments  were  formulated  by  the 
Board,  complementing  its  preliminary  remarks  prior  to  the  meeting.  In  essence  the  Board 
recommended clarifications and improvements of the IA text on five main areas: 

•  The development of the baseline scenario (what will happen if no action is taken)  

•  Clarification of the relationship and interaction of RoHS with other major policies of the 

EU on chemicals (REACH) and environmental performance of products (EuP)  

•  Need  to  support  the  analysis  of  options  and  final  recommendations  with  additional 

quantitative data and quantified arguments 

•  Upgrading of the assessment of the administrative burden 

•  More consistent presentation of the views of stakeholders, in particular with regard to the 
more sensitive options, such as the recommended inclusion of medical devices, control and 
monitoring  instruments  (categories  8&9),  the  adaptation  of  the  list  of  banned  substances 
and of spare parts. 

Further  to  these  comments,  a  baseline  scenario  was  outlined,  information  on  the 
environmental  benefits  of  including  categories  8&9  in  RoHS  and  a  new  annex  giving 
quantitative information on cost impacts and methodological approach and assumptions were 
added; in particular this annex addresses the estimation of the administrative burden from the 
current  RoHS  Directive  and  its  expected  reduction  if  the  recommended  options  are  adopted 
during the RoHS review. As appropriate, key information was inserted also in the analysis of 
options and the executive summary.  

11 

Following two rounds of structured and targeted information collection activities response was received 
from  36  companies  in  total,  out  of  which  20  tried  to  give  a  more  comprehensive  image  of  the  costs 
involved  (Arcadis  report,  p.87-98);  after  two  rounds  of  consultation  on  the  use  of  other  HS  in  EEE, 
Ökoinstitut  observes  that  "…the  manufacturers/supplier  provided  only  very  limited  information  on 
concentrations  or  quantity  ranges  of  hazardous  substances  in  electrical  and  electronic  components. 
Therefore,  it  will  be  difficult  to  estimate  the  relevance  of  EEE  for  the  total  consumption  of  the 
substances…" 

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The relationship with REACH and RoHS was further explained, including in the analysis of 
options, as well as some further elements from the broader context (ECJ ruling on DecaBDE), 
necessary for better understanding of options and recommendations. Stakeholders' views were 
more amply presented in the introduction and some individual key options. 

2. 

PROBLEM DEFINITION 

2.1. 

Problems requiring action 

EEE contains numerous substances that can harm human health and the environment (Annex 
I)  if  the  equipment  is  designed  inappropriately  or  treated  inappropriately  during  its  use  or 
when discarded. These risks keep growing as rapidly growing consumption of EEE in the EU 
and globally would increase the amounts of hazardous substances (HS) that, unless managed 
properly,  can  end  up  in  the  environment  and  humans12.  Sound  management  of  waste  from 
EEE (WEEE) reduces release of HS into the environment and Community legislation to this 
effect is in place. However, even in the EU less than one third of WEEE arisings are treated 
according  to  this  specific  legislation  much  of  the  rest  being  illegally  dumped  or  shipped 
outside the EU, with severe environmental and health impacts.  

The RoHS Directive therefore aims at reducing the future risk of the most harmful HS release 
from  EEE  at  source  by  reducing  the  use  of  these  substances.  It  thus  complements  other 
measures such as separate waste collection and treatment, while ensuring the free movement 
of EEE on the Community market. The RoHS Directive therefore is a building block within a 
set of  Community legislation  to reduce  the  risk  of  environmental  and  health  impacts  due  to 
the release of HS. 

The  Directive  has  been  in  force  for  less  than  two  years.  During  this  time  it  has  already 
reduced the use of HS in EEE and thereby the risk of exposure significantly (Annex I). Within 
this time neither the drivers mentioned above nor the rationale for reducing the use of HS in 
EEE  outside  the  scope  of  the  legislation  have  changed.  Although  it  was  necessary  for  the 
calculations  to  use  a  hypothetical  scenario  whereby  all  EEE  would  be  replaced  by  RoHS 
compliant equipment13, one has to take into account that the environmental benefit from the 
RoHS substance ban enacted in 2006 will be felt for many years to come, considering that for 
some EEE it can take years or even decades before they reach the end of life stage. 

In  addition,  experience  with  the  first  years  of  implementation  has  indicated  technical,  legal 
and  administrative  problems  that  result  in  unintentionally  high  efforts  or  costs  for  market 
actors and administrations in complying with the Directive. Most recently, the Electra report14 

12 

13 
14 

About  70%  of  heavy  metals  (mercury  and  cadmium)  in  US  landfills  come  from  electronic  waste. 
Consumer electronics make up 40% of the lead in landfills, Environmental Impact Assessment review 
25 (2005), p.444. Although some benefits from RoHS in terms of decrease of human toxicity potential 
and ecotoxicity have been identified (Arcadis study, p. II) it is not possible due to the complexity and 
uncertainties  involved  to  evaluate  fully  the  avoided  exposure  and  direct  environmental  and  health 
impacts attributable to RoHS 
Arcadis report, p.69 
"Electra" is a joint initiative by the EU’s electrical and electronic engineering industry and the European 
Commission;  in  a  report  issued  in  June  2008,  general  recommendations  on  several  EU  policy  acts, 
including  RoHS,  are  formulated  :  "…RoHS  transpositions  are  quite  divergent  in  different  member 
states. Some member states, for instance, reject the New Approach understanding in the context of the 
putting products on the community market. Other countries, Austria, Italy included the «Homogeneous 

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recommends  harmonisation  of  the  RoHS  scope  and  of  its  application,  including  use  of  EU 
horizontal product related legislation, where applicable. 

Alleviating these problems would enable faster, more comprehensive and more cost-efficient 
achievement of the environmental and market objectives . 

•  Implementation-related problems 

The following shortcomings have been identified15: 

– 

– 

– 

– 

– 

– 

Continued environmental harm from products which are in practice treated as outside 
the Directive's scope due to uncertainty about whether those products fall within the 
RoHS scope16; 

Insufficient  approximation  of  Member  States'  (MS)  laws  with  regard  to  authorities' 
views as to when an EEE is considered to have been placed on the market, resulting 
in uncertainty whether it is considered to fall under the scope of RoHS ban (entering 
in force on 1 July 2006) or not; 

Unintended  and  unnecessary  legal  counselling  and  personnel  costs  for  economic 
operators  who  need  to  track  potentially  diverging  transpositions  of  the  RoHS 
Directive and associated legislation (e.g. Commission decisions on exemptions); 

Operators  placing  EEE  in  the  markets  of  different  Member  States  have  to 
demonstrate  product  compliance  (for  example,  what  means  "lead-  or  cadmium-
free"?)  in  different  ways  as  some  Member  States  have  specified  differing 
methodologies.  This  creates  additional  administrative  costs  for  operators  trading  in 
more  than  one  Member  State.  Other  Member  States  have  not  specified  any 
methodology on how to demonstrate compliance which leads to delay and additional 
personnel costs; 

Perceived shortcomings in the exemptions procedure, which are addressed in detail 
below in relationship to adaptation to technical/scientific progress; 

Uncertainty about the status of "spare parts"; although there is no information on the 
quantities  of  non-compliant  parts  which  are  placed  in  the  market  by  manufacturers 
and  whether  they  are  used  exclusively  for  the  EEE  (placed  in  the  market  before 
01/07/2006) for which they are destined according to the current RoHS text, it would 
seem  that  certain  types  of  equipment  are  considered  by  some  stakeholders  as 
"part/component" and not "final product" which, in their view, can be the only type 
of equipment falling under RoHS. 

•  Enforcement-related problems 

material»  definition  in  national  laws  (but  for  Italy,  there  is  a  divergence  from  European  Commission 
F.A.Q.  document  of  24  May  2005).  Germany  and  Italy  included  MCVs  (maximum  concentration 
values)  into  transposition  laws.  Proposals  for  improvement:  The  scope  of  RoHS  should  be  fully 
harmonised. As a matter of better regulation, the European Commission should continue to put pressure 
on national governments to ensure a harmonised application of the directive…" 
See  ARCADIS  study,  part  5.2.2.3,  p.103-104  and  industry  contributions  to  the  stakeholder 
consultations: http://ec.europa.eu/environment/waste/weee/events_rohs2_en.htm 
See ARCADIS study, p.133 

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15 

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First  market  surveillance  activities  have  revealed  a  potentially  high  (up  to  44%  in  one  MS) 
proportion  of  non-compliant  EEE  on  the  market  which  increases  the  risk  of  future 
environmental harm. This could indicate need for possible further measures for enforcing the 
national  laws  implementing  the  RoHS  Directive  and  some  ineffectiveness  of  proportionate 
and dissuasive penalties.  

Costs and effectiveness of the enforcement action that Member States do take would improve 
and  synergies  created  by  better  communication  through  the  internal  market.  Unequal 
treatment of EEE on the internal market17 and resulting additional, unnecessary administrative 
costs18  as  Member  States  have  taken  divergent  approaches  with  respect  to  national 
enforcement. 

The  recently  adopted  Regulation  concerning  market  surveillance19  ("Marketing  of  Products 
Package")  will  apply  also  to  RoHS,  however  this  is  not  likely  to  be  clear  to  economic 
operators,  and  may  not  be  immediately  clear  to  many  enforcement  authorities,  so  some 
confusion  and  difference  in  implementation  across  the  Member  States  is  predicted  to 
continue.  

•  Problems  related  to  perceived  inconsistency  with  other  Community  legislation  or 

technical/ scientific progress. 

Since  the  development  of  the  RoHS  Directive  several  major  new  pieces  of  Community 
legislation  have  been  adopted  with  objectives  and  scopes  related  to  those  of  the  RoHS 
Directive  but  the  legal  and  practical  consequences  of  these  relations  are  not  always 
sufficiently  clear  for  operators.  There  are  perceptions  of  inconsistencies  between  RoHS  and 
other pieces of EU legislation, leading to unnecessary legal counselling costs and possibly to 
unintentional infringements of legislation.  

Beyond  the  HS  already  regulated  by  RoHS,  many  other  substances  that  are  used  in  EEE 
present similar hazards to health and environment (Annex II). These have been investigated in 
the  course  of  the  present  review,  at  the  request  of  the  European  Parliament  and  Council,  to 
establish if further substances should be included in the RoHS substance ban.  

Certain categories of EEE outside the scope of RoHS contain hazardous substances with the 
related human and environmental risks. In the course of the present review, at the request of 
the European Parliament and Council stated in the text of the Directive, the Commission has 
investigated  if  the  scope  should  be  widened,  in  particular  to  medical  equipment  and 
measuring instruments. 

Certain applications of the banned HS in EEE cannot be avoided as substituting them is either 
scientifically  or  technically  impracticable  or  would  lead  to  more  negative  impacts  than  the 

17 

18 

19 

Martin  et  al.  In  "The  EU  restriction  of  Hazardous  substances  Directive:  Problems  arising  from 
Implementation  Differences  between  Member  States  and  Proposed  Solutions",  (RECIEL  16(2)  2007, 
Blackwell Publishing Ltd) present the results of telephone interviews conducted with 21 Member State 
RoHS enforcement officials and come across, inter alia, different interpretations of the phrase "put on 
the market", different expectations on evidence for RoHS compliance to be supplied by manufacturers 
different  penalties  for  non-compliance  and  varying  levels  of  fines  as  well  as  different  preferences  of 
RoHS enforcement officials towards market surveillance. 
"Collecting  and  reviewing  information"  accounted  for  49%  of  administrative  burden,  according  to 
ARCADIS study, part 5.2.2.3, p.104 
Decision 768/2008/EC and Regulation (EC) 765/2008, OJEU L218, 13.08.2008 

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present  situation.  It  is  therefore  necessary  to  exempt  such  applications  from  the  legal  ban. 
However,  the  RoHS  process  for  granting  exemptions  has  proven  too  cumbersome  and  too 
lengthy  to  keep  pace  with  innovation,  in  particular  for  products  with  lead  to  market  times 
which can be in some cases even shorter than the exemption procedure. Producers therefore 
experience  delays  in  being  allowed  to  put  equipment  on  the  market  and  administrators  face 
legal  uncertainty  when  trying  to  assess  the  compliance  of  such  equipment.  Especially  for 
products with short innovation cycles this can lead to significant economic losses. 

2.2. 

Underlying drivers of the problems 

•  Implementation-related problems 

Implementation-related  problems  (notably  difficulties  in  deciding  whether  certain  products 
fall  within  the  scope  of  RoHS  and  diverging  views  among  Member  States  authorities  as  to 
when putting on the market of an EEE is deemed to take place) are driven by a lack of clear, 
agreed scope of RoHS and by a lack of clarity in legal provisions and definitions. A lack of 
precision in the RoHS Directive is contributing to this. 

•  Enforcement-related problems 

Enforcement-related  problems  (notably  too  many  non-compliant  products  and  unequal 
treatment of EEE in the internal market) reflect disparities in MS' approaches and the political 
priority,  resources  and  organisation  given  to  product  compliance.  Disparities,  in  turn,  are 
partly due to differing perceptions by Member States of what constitute effective mechanisms 
for reporting, assessing product compliance and carrying out market surveillance.  

•  Coherence/consistency-related problems 

Problems arising from mis-perceptions of the inter-relation between legislation are largely due 
to uncertainty about the relation of RoHS and newer policies and legislation such as REACH 
and  EuP.  The  problem  is  driven  by  the  need  of  market  players  to  ensure  compliance  with 
different pieces of closely related legislation while trying to minimize additional burden and 
efforts without reference to authoritative and user-friendly explanations or cross-references.  

Restrictions in scope are related to incomplete knowledge at the time the RoHS Directive was 
created, whilst technical and scientific progress has now provided more information. This has 
caused the exclusion of other product categories that could have enhanced the benefits of the 
Directive. 

Inconclusive and incomplete scientific and socio-economic information is also the main driver 
behind problems related to adapting the list of banned substances. 

Finally, the complexity of the scientific work needed and necessity for extensive stakeholder 
consultation  for  deciding  on  whether  exemptions  from  the  substance  ban  are  justified  is 
driving  the  lengthiness  and  of  administrative  and  procedures  for  granting  or  withdrawing 
exemptions.  Furthermore,  an  under-representation  of  socio-economic  considerations  in  the 
process can cause market disadvantages for producers that are refused exemptions as a result 
of insufficient cost-benefit assessments. 

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2.3.  Who is affected, in what ways, and to what extent? 

– 

– 

– 

– 

– 

– 

– 

Companies  that  place  EEE  on  the  EU  market,  such  as  manufacturers  (who  have  to 
adapt  the  design  of  their  products,  need  legal  certainty  as  to  whether  their  product 
falls  under  the  scope  of  RoHS  and  want  to  benefit  from  its  free  movement  in  the 
internal  market)  and  importers/distributors/distant  sales  operators  who  can  be  held 
responsible for compliance of the EEE they place on the market; 

Enforcement  officials  in  Member  States  administrations  who  need  clear  rules  and 
efficient 
tools  for  assessing  product  compliance  and  carrying  out  market 
surveillance; 

Suppliers of parts and components, including in 3rd countries, because they need to 
adapt their products to the requirements of their client; 

Producers of the HS; 

Recyclers and other waste treatment facilities operators, because the complexity and 
cost  of  the  WEEE  treatment  depends  to  a  certain  extent  on  its  composition  and  in 
particular its content of HS; 

Users  of  EEE,  workers  in  EEE  production  and  WEEE  recycling  and  treatment 
facilities (in the EU and particularly overseas), because of potential exposure to HS; 

The civil society at large because of the negative environmental and health impacts 
from  the  release  of  HS;  design  changes  can  affect  product  price,  availability  of 
products and functions. 

2.4. 

How would the problem evolve, if no action is taken 

•  Risks  for  environment  and  health  from  exposure  to  Hazardous  Substances  in  EEE  and 

already regulated by RoHS 

There  are  various  factors  which  will  influence  this  exposure  over  time,  making  forecasts 
about future overall levels of exposure in the EU and in third countries difficult: 

The weight of WEEE produced in the EU is increasing, from an estimated 8,3 to 9,1 million 
tonnes per year in 2005 to 12,3 million tonnes by 2020. This tendency is further exacerbated 
for  some  products  with  short  innovation  cycles,  in  particular  in  the  information  and 
communication technologies and the consumer electronics sectors. 

On the other hand the phasing out of the use of substances, enacted in 2006, as well as of the 
exemptions  granted  will  contribute  to  a  reduction  of  exposure  for  the  next  5  to  10  years  at 
least. Indeed, one needs to take into account the life time of EEE which is quite diverse and 
can be even longer that 20 years for some specialised products. This means that there can be a 
considerable time span from product design and end of life of the product meaning that the 
environmental  benefits  will  be  reaped  gradually,  taking  also  into  account  the  recommended 
differentiated  enforcement  dates  and  the  proposed  exemptions,  which  are  to  be  phased  out 
when substitutes become available. 

In particular with regard to third countries, where severe environmental and health problems 
have  been  observed  due  to  unsafe  handling  of  WEEE,  the  actual  exposure  will  depend  on 

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many factors including the efficient checking of illegal WEEE shipments, the improvement of 
facilities and strengthening of environmental legislation and enforcement in these countries as 
well  as  on  the  raw  materials'  prices  which,  if  high,  can,  in  some  cases,  be  an  incentive  for 
illegal shipments and low cost/below standard treatment. 

Concerning  the  percentage  of  non-compliant  products  placed  on  the  market,  first  market 
surveillance campaigns show that in some cases (one MS); it can be as high as 44%. Due also 
to  the  rather  short  time  since  the  entry  into  force  of  the  ban  (July  2006)  there  is  not  much 
information from market surveillance activities; 10 MS have reported inspection campaigns; 
these  campaigns  covered  various  numbers  of  EEE  products  and  companies  (below  100), 
involved  various  degrees  of  requests  for  compliance  documentation&testing  and  resulted  in 
warnings or even (very few) withdrawals of products; the results of most of these campaigns 
have not been published or are not even available.. The scarcity of data does not allow us to 
have an overview of the % of the EEE placed in the Community market which are not fully 
RoHS  compliant  or  an  idea  about  the  evolution  of  this  percentage  since  the  last  data  were 
provided. 

However, this percentage is expected to drop with increasing knowledge of the Directive and 
more systematic checking at national level with the appliaction of the recently adopted related 
Regulation  (in  the  context  of  the  "Marketing  of  products  package").  Obviously  the  actual 
improvement  will  depend  on  the  extent  of  the  market  surveillance  activities  that  national 
authorities  will  deploy  and  the  efforts  that  manufacturers  will  undertake  to  improve  and 
demonstrate compliance; but no drivers for a change in these trends are currently observed. 

Looking at the problem caused in particular by medical devices and control and monitoring 
instruments, although it is claimed that many of these products due to their specialized use are 
not  disposed  of  in  an  uncontrolled  way  at  their  end  of  life,  studies20  show  that  only  50% 
(medical devices) to 65% (control and monitoring instruments) are being separately collected. 
On  the  reasonable  assumption  that  a  large  proportion  of  those  products  not  collected 
separately are not being treated and recycled according to high environmental standards, this 
means that there is a risk that a large proportion of the HS they would contain will be released 
in the environment. This is predicted to lead to environmental harm, as reflected by toxicity 
indicators  such  as  human  toxicity  potential,  freshwater  aquatic,  freshwater  sedimental  and 
terrestrial ecotoxicity potentials.  

It seems highly unlikely that the content of the substances in these products will be affected in 
the short to medium term (e.g up to 2016) by either REACH or EuP given that most of these 
substances  are  already  regulated  for  many  uses  and  there  is  no  indication  that  they  can 
constitute  a  priority  under  REACH.  Many  of  these  products  (for  example  computer 
tomography  scanners  or  x-ray  electron  microscopes)  do  not  meet  the  EuP  threshold  of  200 
000 units sold per year; such complex and specialised products due to their size can also be 
assumed to represent a higher % in the overall WEEE tonnage than their sold numbers would 
make  believe21;  the  fact  that  they  normally  do  not  have  energy  consumption  as  their 
overriding  environmental  impact  brings  them  further  down  the  priority  list  of  EuP  at  this 
stage.  

20 
21 

UNU study, final report August 2007 carried out to support the WEEE review 
On the basis of the ERA report, p.51 it can be estimated that they could amount to more than 20 000 
tonnes out of the total of almost 27 000 tonnes estimated by industry (COCIR and EDMA) 

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These categories of products account for approximately 1% of all EEE sold annually in EU 
and  for  0,2  –  0,3%  of  WEEE  by  weight.  The  quantities  of  HS  contained  in  them  are  much 
lower  compared  with  other  applications  (for  example  lead  or  cadmium  in  batteries)  and  in 
total  would  amount  to  approximately  1400,  2,2,  0,03  and  0,8  tonnes  of  lead,  cadmium, 
mercury and hexavalent chromium respectively. They contain also approximately 10 tons of 
deca-BDE22.  

Industry  claims  that  lead-free  soldering  is  anyway  increasingly  used  (mainly  in  preparation 
for  an  expected  introduction  of  these  products  into  the  scope  of  RoHS)  with  estimates  that 
current use of lead for solders in category 8 products amounts to roughly 0,08% of the overall 
lead  use  in  EU23  with  predictions  that  this  on-going  substitution  would  reduce  the 
consumption of lead in future by up to 90%. However, if these products are not included now 
in  RoHS  it  is  highly  likely  that  the  momentum  for  substitution  and  related  voluntary 
initiatives  (such  as  use  of  an  eco-design  standard)  developed  with  the  perspective  of 
legislation  may  subside.  Some  re-introduction  of  lead  solder  over  time  would  also  be 
expected. 

•  Unnecessary Costs 

If no action is taken, divergent implementations of the RoHS Directive at national level will 
persist, preventing EEE manufacturers to make best use of a well functioning internal market. 
Uncertainty  among  manufacturers  about  legal  requirements  for  demonstrating  RoHS-
compliance  and  about  enforcement  methodologies  in  the  27  Member  States  will  persist, 
maintaining or increasing administrative burden and legal uncertainty. 

The  Impact  Assessment  of  the  Marketing  of  Products  Package24  indicates  that  product 
conformity assessment related costs can be on the average up to 1-2% of unit production cost 
(less  for  large  scale  production)  for  complying  with  related  requirements  in  the  area  of 
harmonised EU legislation affecting EEE, e.g. on safety.  

The  RoHS  Directive  currently  does  not  foresee  explicit  reporting  obligations  for  Member 
States  or  for  information  supply  requirements  by  manufacturers  in  RoHS  and  in  most  cases 
Member  States  have  not  introduced  such  legal  obligations  at  national  level  either  for 
manufacturers. This makes an estimation of the current costs for manufacturers resulting from 
potentially divergent expectations of MS authorities for compliance demonstration  and their 
development impossible; they might now be less or more that the abovementioned rate of 1-
2% 

If  RoHS  is  not  amended,  several  of  the  provisions  of  the  "Marketing  of  Products  Package" 
will apply automatically, but this is not likely to be clear to economic operators, and may not 
be immediately clear to many enforcement authorities; the result could be costs higher than 1-
2%  which  would  be  the  maximum  expected  rate  if  harmonised  conformity  assessment 
requirements are introduced in RoHS.confusion and difference in implementation across the 

22 

23 
24 

The figures provided in the ERA report, p.71 come from various sources and it is not clear whether they 
refer to yearly quantities placed on the market or to the HS contained in category 8&9 present in the EU 
market at a given moment. Industry (COCIR contribution to the stakeholder consultation) estimates that 
the amounts (tonnes) of lead, cadmium hexavalent cromium and mercury contained in medical devices 
put on the EU market each year are respectively 1148,/1,7/0,008 and 0,012 
EDMA contribution to the stakeholder consultation 
P.58 

EN 

21 

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Member  States.  The  future  annual  cost  for  RoHS  compliance  is  estimated  at  0,04%  of 
turnover (minimum 165 million €, maximum 23000 m illion €, see Annex V) and is estimated 
to decrease over time because EEE manufacturers and their suppliers become more familiar 
with  RoHS.  However,  it  might  turn  out  to  be  higher  if  the  unnecessary  costs  from  lack  of 
clarity and divergent Member State practices are not addressed, in particular if more rigorous 
and wide-spread conformity assessment and market surveillance activities take place.  

The  number  of  exemption  requests  is  expected  to  decrease  for  the  EEE  already  covered  by 
RoHS  due  to  the  maturity  of  the  increasing  availability  of  field  data  for  substitutes  which 
would  promote  their  reliability  and  availability;  it  cannot  however  be  excluded  that  some 
exemptions will still be needed for innovative applications for which their intrinsic properties 
make the banned substances suitable; as far as costs are concerned, they could further fall, due 
to familiarisation of manufacturers with the procedure, further possible improvements through 
guidance documents or standard formats and also due to the decreasing number of requests. 

2.5. 

The EU right to act 

This  is  a  review  of  existing  Community  legislation,  put  in  place  to  tackle  problems  arising 
with  both  products  and  waste.  Moreover,  Council  and  the  European  Parliament  have 
explicitly called on the Commission in Articles 4(3) and 6 of the RoHS Directive to review 
the  measures  provided  for  in  the  Directive,  taking  into  account,  as  necessary,  the 
precautionary principle and new scientific evidence, in particular with regard to the inclusion 
of two additional categories of equipment in the scope (categories 8&9: medical devices and 
monitoring and control instruments) and the adaptation of the list of restricted substances.  

This  review  is  a  part  of  work  to  developing  a  better  regulatory  environment  in  the  EU, 
respecting  the  principles  of  subsidiarity  and  proportionality.  Simplification  intends  to  make 
legislation at both Community and national level less burdensome, easier to apply and thereby 
more  effective.  The  Commission  is  committed  to  reduce  unnecessary  burdens  while 
preserving the level of environmental protection. 

3. 

OBJECTIVES 

3.1. 

Objectives  

The  general  objective  is  to  achieve  the  objectives  of  the  RoHS  Directive  more  effectively 
and efficiently, thus optimizing benefits for the society as a whole in return for the legislative, 
administrative  and  economic  efforts  required,  thereby  to  contribute  to  a  better  regulatory 
environment  that  is  simple,  understandable,  effective  and  enforceable,  thus  advancing 
sustainable  development  and  environmental  protection  while  helping  businesses  to  maintain 
its competitiveness and ability to grow and create jobs.  

The specific objectives are to: 

– 

– 

– 

Bring  clarity  to  the  users  about  the  requirements  of  the  Directive  and  simplify  its 
operation; 

Cut unnecessary costs for relevant business; 

Minimize the numbers of non-compliant products by improving the enforcement of 
the Directive. 

EN 

22 

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This leads to three operational objectives defined as follows: 

(1) 

A clearer Directive that is simpler in its operation and  is clearly  coherent with  other 
pieces of EU legislation: 

(a) 

(b) 

A  harmonized  RoHS  scope  in  all  Member  States  with  clarity  on  products 
included  in  the  "grey"  areas  (e.g.  "part  of  another  equipment")  and  clarity  on 
important terminology, e.g. "put on the market";  

Definitions  that  are  easier  to  interpret  (for  example  in  line  with  Community 
product legislation). 

(c) 

Clarity for users on the relationship to other legislation 

(2) 

Improved enforcement of the Directive at national level: 

(a)  Minimized  number  of  non-compliant  products  by  improved  effectiveness  of 

enforcement;  

(b) 

Increased legal certainty for operators across the internal market. 

(3) 

A Directive that is adapted to technical and scientific progress : 

(a) 

(b) 

(c) 

Faster mechanism for granting exemptions; 

A product scope adapted to technical and scientific progress; 

Restrictions  on  use  of  HS  in  EEE  where  justified  by  scientific  facts  and  the 
precautionary principle; 

3.2. 

Consistency of these objectives with other EU policies  

In  the  course  of  implementation  questions  have  been  raised  with  regard  to  coherence  and 
complementarity between the WEEE and RoHS Directives and with other Community policy 
and  legislation  introduced  since  their  adoption.  These  include  notably  the  Lisbon  and 
Sustainable Development Strategies (including simplification/better  regulation), the “Energy 
and  Climate”  Package,  the  6th  Environment  Action  Programme  and  the  Community 
Strategies on natural resources and waste management, other Community Strategies (IPP, the 
marketing  of  products,  lead  markets),  REACH  (regarding  the  use  of  substances),  the  EuP 
Directive  (regarding  the  design  of  EEE)  and  other  legislation  related  to  EEE  and  its  waste 
management.  

Synergies  between  the  RoHS  Directive  and  REACH  and  the  EuP  Directive  are  particularly 
relevant. 

REACH focuses on the chemical substances while RoHS is product legislation dealing only 
with hazardous substances in EEE. The complementarity consists in that, if a substance that is 
subject  to  authorisation  under  REACH  is  restricted  under  RoHS,  such  application  will  be 
exempted  from  the  REACH  requirements;  it  explains  why  RoHS  and  the  subsequently 
adopted  REACH  were  meant  to  coexist  and  ensures  that  any  conflict  between  REACH  and 
RoHS is avoided. 

EN 

23 

   EN 

 
EuP  addresses  toxicity  as  one  among  all  significant  environmental  aspects  of  a  product  and 
during  the  first  phase  of  implementation  focuses  on  energy  efficiency;  it  was  not  meant  to 
examine  the  use  of  individual  hazardous  substances  nor  can  preparatory  studies  for 
implementing measures dwell on the feasibility (technical/economic) of their substitution with 
the necessary degree of detail. EuP contains an explicit reference to RoHS, ensuring that any 
conflict is avoided; if the EuP preparatory studies reveal the need for measures on a hazardous 
substance,  this  will  be  done  under  RoHS  (as  recently  the  case  for  mercury  in  lamps).The 
assessment in Annex IV shows that the RoHS Directive is complementary and coherent in its 
substance  with  other  relevant  Community  legislation.  Nevertheless,  some  scope  for  better 
clarifying  these  relations  and  modernizing  terminology  in  line  with  newer  policy  exists. 
Options for doing this are also discussed in this impact assessment. 

4. 

DESCRIPTION OF POLICY OPTIONS 

Options are grouped in relation to the objectives described in section 3. To focus the analysis 
on the most important possibilities, other options which the Commission had considered at an 
earlier stage but found unsuitable are given in Annex III. 

4.1. 

Options to clarify and simplify the Directive 

The below  mentioned options 4.1.2- 4.1.5 are not mutually exclusive but complementary in 
serving objective 1. 

4.1.1.  Make no changes to scope or definitions 

4.1.2.  Create an independent scope for RoHS  

To date, RoHS refers to the WEEE Directive for its scope; this option consists in providing to 
RoHS an independent, harmonised scope; in addition, through this option the current WEEE 
annex with indicative examples is transformed to a binding one and can be amended through 
Committee procedure.  

As  an  option  in  the  review  of  the  WEEE  Directive  it  is  considered  to  remove  the  annexes 
defining the scope from the WEEE Directive; the WEEE Directive would refer for its scope to 
the RoHS Directive.  

4.1.3.  Clarification on spare parts 

(a) 

Explicit inclusion of spare parts 

RoHS does not define "spare parts"; an option for increased clarity and legal security would 
be to include them explicitly in RoHS  

(b) 

"Repair as produced principle" 

This  option  would  modify  the  legal  text  of  RoHS  so  that  it  is  explicitly  allowed  that  EEE 
using  a  banned  substance  in  an  application  exempted  from  the  ban  when  placed  on  the 
market, would be able to be repaired and reused with parts using the banned substance in this 
application even after the expiry of the exemption. 

EN 

24 

   EN 

 
4.1.4.  Clarification on excluded equipment 

The WEEE Directive excludes explicitly some types of equipment; although the Commission 
services  and  stakeholders  consider  that  these  exclusions  apply  for  RoHS  as  well,  it  is  not 
written in the RoHS legal text; this option consists in explicitly excluding military equipment 
and  equipment  which  is  part  of  another  equipment  in  the  definition  of  the  RoHS  scope. 
Specifically to: 

(d) 

(e) 

Insert in RoHS clause similar to WEEE Art 2.1 (excluding equipment which is 
part of another type of equipment that does not fall within the scope); 

Insert in RoHS clause similar to WEEE Art 2.3 (excluding equipment which is 
intended for specifically military purposes). 

4.1.5.  Adding/modifying definitions 

This  option  would  be  to  insert  several  definitions  into  the  text  of  RoHS.  These  would  be 
definitions  relevant  for  RoHS  from  the  recently  adopted  "Marketing  of  Products  Package"; 
definitions  for  medical  devices  and  industrial  control  and  monitoring  equipment;  definition 
for "homogeneous material" from the Guidance Document of the Commission services25. 

4.2. 

Options to improve enforcement 

The options 4.2.2–4.2.3 are not mutually exclusive but complementary in serving objective 2. 

4.2.1.  Make no changes: not add provisions aiming at better enforcement 

4.2.2. 

Strengthen mechanisms to remove non-compliant products from the market 

This  option  consists  in  inserting  provisions  from  the  "Marketing  of  Products  Package" 
establishing  obligations  for  Member  States  to  carry  out  market  surveillance  activities  with 
regard to products' compliance with RoHS, to exchange information on enforcement activities 
and  cooperate  with  other  Member  States  and  the  Commission  for  spotting  non-compliant 
products.  The  "Marketing  of  Products  Package"  provides  a  consistent  legal  framework 
including  harmonised  definitions,  obligations  for  the  economic  operators  and  safeguard 
mechanisms intended to apply across sectoral EU product legislation. 

4.2.3.  Harmonize methods for demonstrating compliance 

The below options a) and b) are mutually exclusive 

(a) 

Include  conformity  assessment  procedures:  use  of  standards,  self  declaration 
and CE marking 

Insert the obligation for producers to carry out internal design control for compliance of their 
products with RoHS and affix the CE marking before placing them in the market and give the 
possibility to use EU harmonised standards 

25 

http://ec.europa.eu/environment/waste/weee/pdf/faq_weee.pdf. 

EN 

25 

   EN 

 
                                                 
(b) 

Include  conformity  assessment  procedures:  use  of  standards,  external 
verification and CE marking 

Insert the obligation for producers to have  verification of compliance of their products  with 
RoHS by a third party carried out and affix the CE marking before placing them in the market 
and give the possibility to use EU harmonised standards. 

4.3. 

Options to adapt the Directive to technical and scientific progress 

4.3.1.  Exemptions 

4.3.1.1.  Make no changes to the exemption mechanism 

4.3.1.2.  Remove the exemption mechanism from the Directive. 

The ban of the substances would be total (no possibility for exemptions) but this ban would 
only apply to those products which do not create a need for exemptions. 

4.3.1.3.  Maintain  the  exemptions  procedure  with  changes  in  the  criteria  for  granting  and 

withdrawing exemptions 

(a) 

introduce requirement for analysis of substitutes 

Insertion of obligation for manufacturers requesting an exemption to submit their analysis for 
possibilities  of  substitution  of  the  banned  substance  in  the  application  and,  if  possible,  a 
substitution  plan.  A  similar  provision  exists  in  the  REACH  regulation  (Article  (62)(4)(e)); 
detailed rules will be set out in the standard format to be produced by the Commission. 

(b) 

introduce broader criteria for granting exemptions 

These  would  be  availability  or  reliability  of  substitutes.  If  availability  or  reliability  of 
substitutes  is  not  ensured,  an  exemption  should  be  granted,  so  as  to  avoid  negative 
socioeconomic  effects,  such  as  steep  price  increases  and  withdrawal  of  products.  The 
Regulatory Committee will assess to which extent these criteria are met. 

(c) 

introduce standard format and validity period 

Creation,  through  Committee  procedure,  of  a  standard  format  for  exemption  requests;  by 
default, an exemption expires after 4 years, unless a renewed request is accepted. 

4.3.2.  Adapt product coverage to technical and scientific progress 

4.3.2.1.  Remove all products from scope of RoHS – repeal RoHS 

Scientific and technical progress may facilitate voluntary substitution of the HS regulated by 
RoHS  and  hence  help  achieving  the  objectives  of  RoHS  in  a  more  cost-effective  way.  This 
option would involve the effective repeal of RoHS and the use of voluntary commitments or 
standards  and  existing  EU  legislation  (Ecodesign  Framework  Directive,  REACH)  to  try  to 
achieve the objectives. 

EN 

26 

   EN 

 
4.3.2.2.  Make no changes, not include Categories 8 and 9. 

Medical devices and 'control and monitoring' instruments (Categories 8 and 9) were included 
in  the  WEEE  Directive  but  excluded  from  the  RoHS  Directive  because  a  longer  adaptation 
period was needed for these products the high reliability of some of which is critical. 

Council  and  Parliament  (in  Article  6  of  the  Directive)  required  the  Commission  to  consider 
their  inclusion.  This  option  would  leave  the  coverage  of  RoHS  unchanged,  Categories  8,  9 
would remain out of the scope of RoHS. 

4.3.2.3.  Include all of Categories 8 and 9 with specific exemptions: 

(a) 

from 2012 

(b) 

from 2014  

(c) 

(d) 

delayed inclusion of cat.9 industrial equipment (2015)  

delayed inclusion of certain medical devices (IVD : 2016, AIMD : 2020) 

This  option  consists  in  including  both  categories  in  the  scope  of  RoHS  and  granting 
exemptions  for  certain  applications  of  the  banned  substances.  The  sub-options  differ  in  the 
deadlines and the treatment of some sub-categories of products. 

a) Inclusion of products falling within categories 8 and 9 from 2012. 2012 is a realistic date 
for the legislative proposal to pass through the legislative process and be implemented by MS. 

b) same as a) but with longer period for adaptation granted. 

c) Can be combined with any of a) or b); independent from 3d):  granting longer adaptation 
period to industrial monitoring and control instruments by submitting them to RoHS in 2015. 

d)  deferred  enforcement  date  for  in  vitro  diagnostic  devices  (IVD:2016)  and  for  active 
implanted  medical  devices  (AIMD  :  2020);  Can  be  combined  with  any  of  a)  or  b); 
independent from c). 

4.3.3. 

Substances covered [Article 6 of RoHS] 

Besides  the  already  regulated  substances  under  RoHS,  EEE  contain  other  HS.  Article  6  of 
RoHS asks the Commission to adapt the list of regulated substances on the basis of scientific 
facts and taking the precautionary principle into account. 

EN 

27 

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4.3.3.1.  Make no changes to the list of substances regulated by RoHS 

4.3.3.2.  Remove substances from the list of banned substances under RoHS  

The  only  substance  for  which  updated  information  justifies  examining  whether  it  should  be 
removed from  the scope of RoHS is DecaBDE, which belongs to the group of PBDEs; this 
option would consist in releasing DecaBDE from the ban26. 

4.3.3.3.  Add  new  substances  for  all  EEE,  in  the  scope  of  RoHS  but  with  exempted 

applications 

In  line  with  the  abovementioned  requirements  of  Article  6  the  results  of  a  study  of  the 
Commission services and other available information, this option consists in extending the list 
of substances banned by RoHS by adding certain HS. 

5. 

ANALYSIS OF IMPACTS 

As  mentioned  before,  it  proved  difficult  to  obtain  all  the  necessary  information  in  order  to 
comprehensively address all the impacts of the policy options. This applies to an even greater 
extent to the social impacts. 

However, during the stakeholder consultations and the preparatory studies two broad kinds of 
impacts of social nature were identified: 

Health:  In  particular  related  to  the  health  of  workers  in  WEEE  recycling  plants;  these  were 
referred  to  earlier  as  well,  in  connection  with  low  standard  recycling  facilities  overseas. 
Similar  concerns  for  plants  in  the  EU  have  been  raised  during  the  stakeholder  meetings  by 
non-profit  organisations  involved  in  WEEE  recycling.  The  recommended  options  for  the 
inclusion of medical devices (section 6) are such that any negative impacts on healthcare are 
avoided.  Finally  all  the  environmental  benefits  of  the  review  would  be  likely  have  a  small 
positive impact on health as well, due to the reduction of the exposure to HS. 

Employment:  Although  economic  operators  and  administrations  had  to  mobilise  human 
resources  for  complying  with  RoHS,  the  preparatory  studies  did  not  reveal  any  substantial 
impact on employment27. There seems however to emerge a positive impact on the quality of 
skills of scientists and engineers involved in the practical implementation of HS substitution. 

These are general observations, and the remainder of this section deals with specific benefits and costs 
for each option. 

26 

27 

On 1 April  2008,  the  European  Court of Justice  annulled the  DecaBDE exemption  granted  through  a 
Commission Decision from 2005. The Court ruled that the risk assessment report does not examine the 
possibility of substituting DecaBDE or the negative effects that substitution could have. Furthermore, 
since  the  updated  risk  assessment  report  is from  2002,  the  Court  concluded  that  the  decision was not 
based  on  technical  or  scientific  progress.  The  Court  thus  ruled  that  the  conditions  for  granting 
exemptions  were  not  complied  with  and  annulled  the  exemption  for  DecaBDE  while  maintaining  its 
effects until 30 June 2008. 
Arcadis study, p.109: in most cases apparently a reallocation of staff took place but no job creation 

EN 

28 

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5.1. 

Options to clarify and simplify the Directive 

5.1.1.  Make no changes to scope and definitions 

Benefits: 

•  No  additional  effort  for  stakeholders  to  get  familiar  with  and  implement  modified 

provisions, hence no additional administrative burden and cost in the short term. 

Costs: 

•  The interpretation difficulties outlined in section 2 will persist or increase because of the 
increasing  variety  of  EEE  and  distribution  outlets,  as  well  as  further  differentiation  of 
implementation  in  MS.  This  would  create  an  administrative  burden  probably  higher  than 
the one avoided by not introducing new provisions for scope and definitions. 

•  Informal  clarification  and  coordination  initiatives  by  Member  States  authorities  and  the 
Commission  services  are  not  legally  binding.  Continued  legal  uncertainty  would  lead  to 
continuing economic risks for manufacturers. 

5.1.2.  Create an independent scope for RoHS 

Benefits: 

•  RoHS regulates product (EEE) design and therefore is based on Article 95 of the Treaty to 
harmonise requirements.. To date, RoHS scope is defined in the WEEE Directive which is 
based on Article 175, which gives Member States much more leeway than Article 95 for 
adding products in the scope.  

•  With  an  autonomous  RoHS  Directive  scope  under  Article  95  manufacturers  can  be 
confident  that  enforcement  authorities  in  the  various  Member  States  will  not  define  the 
scope  of  RoHS  differently.  This  will  reduce  administrative  burden,  legal  uncertainty  and 
related economic risks for manufacturers. 

•  Currently in the WEEE Directive there is a binding Annex (IA) mentioning the broad EEE 
categories falling under  the RoHS scope and an additional annex (IB)  indicating specific 
EEE  falling  under  these  broad  categories.  The  Regulatory  Committee  and  the  informal 
network of Member States enforcement authorities have already been discussing at length 
the  "grey  area"  products  and  have  developed  considerable  expertise28.  Making  Annex  IB 
binding would clarify the scope and therefore reduce administrative burden and would be 
compatible with the legal basis of RoHS (Article 95 of the Treaty, harmonisation).  

•  Environmental and health protection will remain at least at the same level, since this option 

does not foresee removal of any product from the scope of RoHS. 

Costs: 

28 

SeveralMember Statesmeet informally at regular intervals in the context of an "Enforcement Network"; 
this group has produced a "Manual of Decision" aiming to assistMember Statesauthorities in deciding 
whether  an  EEE  falls  within  the  RoHS  scope  or  not;  it  has  also  produced  a  "RoHS  Enforcement 
Guidance Document" for assisting industry in demonstrating andMember Statesin checking compliance 
of EEE with the RoHS Directive 

EN 

29 

   EN 

 
                                                 
•  For many EEE categories both WEEE and RoHS will still apply. Manufacturers and other 
stakeholders will have to implement them jointly and there is a close link between the two 
Directives  (for  example  the  treatment  requirements  of  WEEE  must  take  into  account 
RoHS);  separating  the  scope  will  not  relieve  stakeholders  from  having  in  mind  both 
Directives and some confusion might be created in the early phases of implementation of 
the revised RoHS Directive; however, these costs will be eliminated if RoHS defines the 
WEEE scope (an option examined under the WEEE review). 

•  The adaptation of the annexes by the Regulatory committee might in some cases be longer 
than an informal conclusion as to whether a specific EEE falls under the scope, but, given 
that such discussions are taking place already, additional burden from formalizing them in 
the Regulatory Committee is unlikely. 

5.1.3.  Clarification on spare parts  

(a) 

Explicit inclusion of spare parts 

Benefits: 

•  Currently,  parts  contained  in  EEE  implicitly  have  to  be  compliant  because  the  EEE  as  a 
whole must comply; non-compliant spare parts may be used for EEE placed on the market 
before  1  July  2006.  Clarifying  in  the  legal  text  that  also  parts  which  are  placed  on  the 
market  independently  from  the  equipment  in  which  they  will  be  incorporated  are  in  the 
scope  of  RoHS  would  further  clarify  the  scope  and  hence  include  legal  certainty  and 
reduce  economic  risks,  for  example  from  different  Member  States'  interpretation:  certain 
types  of  equipment  are  considered  by  some  stakeholders  as  "part/component"  and  not 
"final  product"  which,  in  their  view,  can  be  the  only  type  of  equipment  falling  under 
RoHS; such diverging interpretations will cease with the proposed clarification. NGOs are 
in favour of such a clarification. 

•  RoHS allows the use of non-compliant parts in certain cases, and an option to extend this 
derogation  will  be  considered  (“repair  as  produced  principle”,  see  below)  but  there  is  no 
information as to how the existing provision is being enforced by MS, which quantities of 
non-compliant parts are placed in the market by manufacturers and whether they are used 
exclusively  for  the  EEE  (placed  in  the  market  before  1  July  2006)  for  which  they  are 
destined; an explicit provision in the text that parts are included will provide the necessary 
legal clarity basis for Member States and manufacturers to deploy the necessary resources 
for fulfilling their obligations. 

•  Including explicitly spare parts will shift some of the responsibility for compliance to part 
manufacturers and would contribute to spreading clearly and more equally the burden and 
cost of compliance throughout the supply chain. It would facilitate information supply and 
compliance  for  final  product  manufacturers,  who  would  benefit  from  a  reduction  of  the 
administrative cost. 

•  The environmental benefit  of the  clarification of this scope is uncertain, though positive: 
the Commission does not have data on the number of non-compliant parts currently put on 
the market, though it can be expected that the majority of parts used for equipment placed 
on  the  market  after  1  July  2006,  being  replicas  of  components  integrated  in  finished 
products, will be RoHS-compliant already. 

EN 

30 

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Costs: 

•  The practical implementation cost for parts’ manufacturers should not be significant, given 
that,  already  now,  all  parts  and  components  integrated  in  new  finished  products  must  be 
RoHS-compliant. 

•  The  majority  of  industry  stakeholders  are  against  inserting  a  definition  for  "spare  parts" 
and  see  additional  administrative  burden  if  spare  parts  are  made  subject  to  all  the 
obligations  of  RoHS;  however  this  cost  will  be  minimized  if  parts  are  subject  to  the 
substance  ban  but  not  to  the  other  obligations  of  the  revised  RoHS  (e.g.  conformity 
assessment and CE marking). 

(b) 

"Repair as produced principle" 

This  concept  is  implemented  also  in  the  End  of  Life  Vehicles  Directive  for  spare  parts  that 
cannot be redesigned without HS. 

Benefits: 

•  Allowing  the  use  of  non-compliant  spare  parts  for  EEE  placed  on  the  market  while  an 
exemption  was  valid  would  be  beneficial  for  the  environment  since  it  contributes  to 
extending life time and avoiding untimely disposal of equipment. 

•  It  would  bring  legal  certainty  for  manufacturers  with  regard  to  servicing  EEE  after  an 
exemption expires and security for end users that they will not have to replace prematurely 
the EEE because of lack of spare parts. This is particularly important for high cost and long 
life  time  EEE  as,  for  example,  some  medical  equipment  or  other  equipment  for  non-
household use, such as some IT or control and monitoring equipment. 

Costs: 

•  Market surveillance authorities in Member States and EEE manufacturers must deploy the 
necessary  resources  for  ensuring  that  such  a  provision  does  not  lead  to  an  abusive 
generalisation  and  that  the  term  "part"  is  used  properly  (some  industry  stakeholders 
consider whole EEE destined to replace defective products under manufacturers’ guarantee 
as “part”, which should benefit from such an exemption); it is however not clear that this 
effort  will  cost  more  than  the  fulfilment  of  the  current  obligations  under  RoHS,  which 
allows in exceptional cases the use of non-compliant spare parts. 

5.1.4.  Clarification on excluded equipment 

Insert in RoHS clause similar to WEEE Art 2.1 (excluding equipment which is 
part of another type of equipment that does not fall within the scope); 

Insert in RoHS clause similar to WEEE Art 2.3 (excluding equipment which is 
intended for specifically military purposes). 

(a) 

(b) 

Benefits: 

•  The  Guidance  document  prepared  by  the  Commission  services  in  cooperation  with 
Member  States  is  known  and  to  a  large  extent  already  used  by  Member  States  and 
manufacturers;  transposing  its  interpretation  in  the  RoHS  legal  text  will  increase  legal 

EN 

31 

   EN 

 
certainty about the scope and hence reduce administrative burden, particularly by reducing 
differences in interpretation between Member States in future. 

•  Environmental and health protection will remain at least at the same level, since this option 

does not foresee removal of any product from the scope of RoHS 

Costs: 

•  No apparent disadvantages or costs since it would reflect in the legal text what is already 

current practice. 

5.1.5.  Adding/modifying definitions 

Benefits: 

•  Industry  stakeholders  have  pointed  out  at  various  occasions  since  the  entry  into  force  of 
RoHS  that  diverging  interpretations  of  some  concepts  ("placing  on  the  market")  leads  to 
market  fragmentation  ;  defining  them  would  remove  ambiguity,  enhance  the  free 
movement  of  EEE  in  the  internal  market29  lead  to  more  harmonised  interpretation  and 
hence increase legal certainty and reduce economic risks because firms can have the same 
strategy across the EU 

•  Given that tracking the different Member States' transpositions of RoHS requires a lot of 
legal  counselling  and  staff  working  time  substantial  economic  benefits  (reduction  of 
administrative burden for administrations and producers30) can be achieved 

•  In  the  case  of  medical  devices,  adopting  the  definitions  of  other  relevant  EU  legislation 

would create legal certainty;  

•  As  a  postponement  of  the  enforcement  date  is  proposed  for  industrial  control  and 
monitoring  instruments,  clarification  of  what  is  “industrial”  would  increase  clarity  and 
reduce administrative burden for the implementation of this postponed enforcement. 

•  Inserting  the  definition  for  "homogeneous  material"  of  the  Guidance  Document  (already 
largely  used  by  stakeholders)  in  the  legal  text  would  strengthen  the  legal  basis  for  EEE 
manufacturers  in  demonstrating  compliance  and  for  Member  States  during  testing  in  the 
course  of  market  surveillance  activities;  it  will  also  boost  ongoing  standardisation 
processes, which tend to be quicker and more efficient when they are intended to support 
the implementation of legal requirements. 

Costs: 

•  Inconvenience  and  need  for  adaptation  in  the  case  where  differing  interpretations  have 
been  given  to  various  definitions  and  implementation  was  based  on  them;  this  is  not 
expected  to  be  significant  because  many  stakeholders  already  apply  the  definitions  of 
relevant Guidance documents. 

29 
30 

Martin et A1, p.225 
Arcadis report, Martin et Al 

EN 

32 

   EN 

 
                                                 
•  Some  stakeholders  raise  doubts  as  to  the  suitability  of  the  available  definition  for 
"homogeneous  material"  for  enforcing  the  ban  (for  example  for  measuring  content  of 
hexavalent  chromium;  it  is  also  claimed  that  small  parts  should  be  considered  as 
"homogeneous material"); if a different definition for "homogeneous material" than the one 
of the Guidance Document would be adopted in the Directive, the inconvenience and need 
for adaptation on such a highly technical issue would give rise to uncertainty and possible 
increase of administrative burden for authorities and manufacturers. 

5.2. 

Options to improve enforcement 

5.2.1.  Make  no  changes:  not  add  provisions  aiming  at  better  implementation  and 

enforcement 

Benefits: 

•  Continuation of flexibility for Member States' administrations in the way they implement 
and enforce RoHS and for EEE manufactures to check and demonstrate RoHS compliance 
in the ways they deem appropriate. 

Costs: 

•  Similarly  to  the  "business  as  usual"  scenario  for  scope  and  definitions,  adding  no  new 
provisions  facilitating  implementation  will  lead  to  a  continuation  of  the  implementation 
problems identified in section 2 and to continued and increased administrative burden and 
problems in the free movement of EEE to the extent that not sufficiently coordinated and 
coherent national market surveillance activities will be deployed. 

5.2.2. 

Strengthen mechanisms to remove non-compliant products from the market 

Benefits: 

•  There is currently no provision in RoHS on how Member State check compliance of EEE 
placed on the market. An explicit provision would mobilise and coordinate efficient market 
surveillance  activities.  This  is  considered  also  by  producers31  a  major  step  to  protect 
compliant  companies  from  unfair  competition  of  non-compliant  products‘:  although  it  is 
difficult  to  estimate  the  share  of  non-compliant  products  on  the  market  first  market 
surveillance campaigns for RoHS show that up to 44% of EEE were found in a Member 
States not to be fully compliant; the loss of industry due to non-compliant products have 
been estimated to range between 4-25%32 of the annual turnover. 

•  Adopting relevant provisions of the "Marketing of products" package will reduce cost for 
administrations (through clarification of obligations, facilitation of internal arrangements, 
sharing  of  resources  among  Member  States  authorities  and  allowing  these  authorities  to 
simultaneously  control  product  compliance  with  requirements  from  several  Community 
legal acts) and increase coherence and predictability for EEE economic operators (such as 
manufacturers, distributors, importers). 

31 
32 

This is also one of the conclusions of the Arcadis report, p.144 
Information from the impact assessment on the Marketing of Products package: figures are taken from 
the SME panel and the enterprise questionnaire and reflect the general tendency; they do not refer to 
RoHS but to other EU harmonisation legislation for EEE (e.g. on safety)  

EN 

33 

   EN 

 
                                                 
•  Effective  market  surveillance  mechanisms  at  national  level  and  harmonised  approach  for 
removal  of  non-compliant  products  would  greatly  enhance  the  environmental  benefit  of 
RoHS  by  minimising  the  number  of  non-compliant  products  on  the  market.  Current 
Member States' checks revealed that up to 44% of EEE checked were not fully compliant. 

•  Structured  cooperation  between  market 

reduce 
administrative  costs  for  both  the  authorities  (for  example  enhanced  information  sharing 
would  avoid  the  need  for  repeating  investigations  on  a  product  done  in  another  MS,  in 
particular regarding expensive testing) and the manufacturers (no need to submit the same 
file in various administrations). 

surveillance  authorities  would 

•  Information availability and exchange would be significantly enhanced by structured and 

harmonised market surveillance 33 

•  The  provisions  on  market  surveillance  are  part  of  the  recently  adopted  Regulation 
("Marketing of Products Package") which means that they would apply even if not inserted 
in RoHS; however, their explicit inclusion will facilitate understanding and promote legal 
certainty of the RoHS legal text both for manufacturers and enforcement authorities 

Costs: 

•  In  the  first  implementation  phases  such  measures  could  create  some  additional  costs  for 
authorities (for example through designating or setting up market surveillance authorities), 
but  this  would  vary  depending  on  current  implementation  practices  of  individual  MS; 
Moreover, given that some work in this direction has already been done (informal network 
exists), additional cost for authorities should be reasonable34. 

•  Administrative  burden  (especially  in  the  first  phases  and  if  they  have  not  already  taken 
measures  for  ensuring  compliance)  also  for  producers,  who  will  have  to  make  available 
documents  to  Member  States  authorities  and  dedicate  time  for  meetings  and  replies  to 
questions. However, such inaction by now would be violation of their existing obligations. 
If  "due  diligence"  is  already  in  place  by  the  manufacturer,  additional  effort  should  be 
minimal. 

•  Since,  as  explained  above,  the  horizontal  EU  provisions  for  market  surveillance  would 

apply to RoHS as well, inserting them in RoHS does not create any additional cost 

5.2.3.  Harmonize methods for demonstrating compliance 

(a) 

Include  conformity  assessment  procedures:  use  of  standards,  self  declaration 
and CE marking  

33 

34 

Market  surveillance  in  FIN  yielded  important  information  on  the  content  of  hazardous  substances  in 
EEE,  
On this point the Impact assessment carried out for the "Marketing of Products" package observes that 
the  costs  for  supporting  the  various  types  of  coordination  and  cooperation  activities  foreseen  in  this 
context by the Community budget is estimated at 1 200 000 € per year. The additional costs for public 
authorities can hardly be quantified but surveys among market surveillance authorities show that only 
21 % expect significant additional costs whilst 60 % of respondents expect an overall reduction of costs 
due to cost savings by more targeted controls enabled by, inter alia, improved information flows  

EN 

34 

   EN 

 
                                                 
(b) 

Include  conformity  assessment  procedures:  use  of  standards,  external 
verification and CE marking 

Benefits: 

•  RoHS  has  currently  no  provision  on  how  manufacturers  should  demonstrate  compliance 
and this means that they either will face diverging requirements or they cannot be sure that 
the  method  they  will  choose  for  ensuring  compliance  will  be  accepted  by  different  MS. 
Inserting  such  a  provision  would  enhance  clarity  for  manufacturers  (for  which  this 
omission  can  be  an  important  source  of  administrative  burden35)  and  for  authorities. 
Although  significant  work  has  been  accomplished  by  their  informal  network,  its 
recommendations  cannot  be  legally  binding.  Establishing  provisions  for  conformity 
assessment  (CA)  in  RoHS  would  therefore  increase  legal  certainty  and  reduce 
administrative costs for manufacturers and authorities alike. 

•  Harmonisation  of  CA  procedures  would  be  beneficial  for  the  internal  market  (some 
Member States already introduce on an individual basis CA procedures or envisage to do 
so,  and  if  they  diverge,  this  might  create  problems  in  the  movement  of  goods)  and  fair 
competition  (including  through  harmonisation  of  requirements  on  documentation  for 
compliance and declaration of conformity).  

•  A  structured,  uniform  CA  procedure  facilitates  the  manufacturers’  efforts  to  achieve 
compliance and Member States' task to verify compliance thus overall reducing the number 
of non-compliant products placed in the market and increasing the environmental benefit. 

•  CE marking provides already presumption of conformity with other EU legislation (e.g. on 
safety)  for  almost  all  EEE  covered  by  RoHS;  if  it  is  extended  to  RoHS  it  will  give 
manufacturers a cost efficient and recognisable means to demonstrate compliance 

•  In  option  2.3  (a)  :  The  “Marketing  of  Products”  package  introduces  CA  procedures  that 
would allow manufacturers to demonstrate compliance with RoHS and a number of other 
Directives in one single document (Declaration of Conformity).  

•  Standards for identification and measurement of the restricted substances, for labelling and 
for communicating across the supply chain facilitate demonstration of product compliance 
and  enforcement  activities  and  can  promote  world  trade;  data  bases  have  proved 
particularly useful in other sectors (automotive), may contribute to maximum availability 
of information at low, or no, cost and could be valuable for SMEs. 

•  In option 2.3 (b): External verification from a neutral body could increase credibility of the 
CA  and  the  checks  would  prompt  greater  compliance  action  by  producers  currently  not 
aware  that  they  are  non-compliant.  It  would  therefore  probably  lead  to  an  increase  in 
substitution of the banned HS compared to self declaration. Otherwise the benefits would 
be the same, as described above. 

Costs: 

35 

Martin et Al, p. 226-227 

EN 

35 

   EN 

 
                                                 
•  Certification of compliance with requirements similar to RoHS is already required in major 
markets  (China).  However,  introducing  such  requirements  for  the  EU  market  via  RoHS 
will incur additional costs for some manufacturers. 

•  The costs for putting in place adequate mechanisms for demonstrating compliance would 
be  higher  for  those  manufacturers  who  still  have  no  such  mechanisms  for  the  existing 
RoHS;  however,  such  inaction  would  mean  that  those  manufacturers  do  not  ensure 
compliance  with  their  obligations  under  the  existing  RoHS.  Those  who  do  ensure 
compliance  will  have  minimal  or  zero  additional  costs  since  they  will  be  able  to  use 
procedures  and  documents  that  they  already  use  due  to  other  EU  legal  requirements  on 
EEE (e.g. on safety) 

•  In  the  case  of  3rd  party  verification  (from  an  external  accredited  organisation  such  as  a 
notified body) such costs would be higher and they could vary substantially depending on 
the  verifying  organisation.  The  ‘normal’  cost  was  considered  to  be  between  €2500  and 
€3000, although some bodies offered the same serv ice for as little as €500 – with evidence 
that  these  lower  prices  are  associated  with  less  stringent  approaches  to  assessment;  third 
party verification under RoHS would probably be similar to that for third party assessment 
of other products36. Binding 3rd party certification has not been considered cost-efficient in 
several other areas (such as safety of electrical equipment or machinery). 

•  The  standardisation  process  can  be  long.  Effort  will  be  required  by  stakeholders  and 
administrations  to  develop  the  harmonised  standards.  If  such  standards  take  too  long  to 
prepare  and  the  Directive  depends  on  their  existence,  the  Directive’s  implementation 
would be delayed. Although international standards can promote world trade and should be 
preferred, when possible, it is only EU harmonised standards that can be expected to be in 
line with the political priorities of the EU. 

5.3. 

Options to adapt the Directive to technical and scientific progress 

5.3.1.  Exemptions 

NB:  This  Impact  Assessment  does  not  refer  to the  content  of  the  Annexes  with  exemptions 
accompanying  the  legal  proposal;  Annex  II  is  currently  under  separate  technical  review  in 
accordance  with  Article  (5)(1)(c)  of  RoHS;  the  draft  proposal  for  the  review  of  RoHS  will 
therefore  include  as  Annex  II  the  current  annex  of  RoHS,  as  amended  by  the  successive 
Commission decisions.  

In Annex III are included the specific exemptions for the new categories of products (medical 
devices and control and monitoring instruments), which preparatory studies have shown to be 
justified. 

The  Impact  Assessment  examines  options  for  reducing  the  administrative  burden  from  the 
current procedure for granting exemptions. 

5.3.1.1.  Make no changes to the exemption mechanism 

Benefits 

36 

Information from the Impact Assessment supporting the Marketing of Products package 

EN 

36 

   EN 

 
                                                 
•  The  few  stakeholders  who  have  used  the  existing  mechanism  have  staff  who  are  used  to 
the existing mechanism and no adaptation effort to a new mechanism would be needed 

Costs 

•  The problems and needs outlined in section 2 will persist or increase due to the increasing 
variety  and  innovative  functions  of  EEE;  this  will  create  administrative  burden  probably 
higher than the one to be avoided if no changes are introduced to the exemption process. 

5.3.1.2.  Remove the exemption mechanism from the Directive 

Benefits: 

•  Avoidance  of 

the  exemptions  granting  procedure  and 

the  associated  required 
administrative effort from authorities and manufacturers; increased clarity about the scope 
of RoHS for manufacturers (product designers would no longer need to consult changing 
lists of exemptions) and facilitation of market surveillance (products within the scope must 
be "free" of the restricted substances, no exemptions to be taken into account). 

•  It  is  estimated  that  manufacturers’  costs  for  exemption  procedures  make  up  about  1%  of 
total  costs  related  to  RoHS37,  which  would  be  the  avoided  cost  if  the  exemption 
mechanism was removed. Although it is difficult to make forecasts on the number of future 
exemption  requests,  there  will  be  some,  not  least  because  of  the  development  of  new 
products; it is expected however that the streamlining of the exemption procedure proposed 
in this review will reduce drastically the number of unjustified requests. 

Costs: 

•  There is no data or information available to determine which product categories can remain 
under RoHS without any exemptions whatsoever, but these are very few. It has not been 
possible  to  demonstrate  for  any  of  the  EEE  categories  currently  covered  that  the 
implementation  cost  is  disproportionate  to  the  environmental  benefit  and  thus  justify  its 
exclusion  from  RoHS.  This  means  that  excluding  all  the  EEE  product  categories  which 
need exemptions so that for the ones remaining in RoHS the whole exemption mechanism 
would be redundant, will most probably reduce substantially the environmental benefit of 
the Directive. 

•  Adopting  this  option  in  relation  to  any  product  group  would  nullify  past  and  ongoing 

compliance efforts by manufacturers. 

37 

Arcadis  report,  p.110.  This  estimation  is  based  on  a  small  sample  of  only  10  companies  which  gave 
quantitative information on costs or time spent in relation to exemption requests; companies indicated 
costs ranging from 1000€ to 2000000€, spread over several years. The Commission services estimate 
that  a  figure  of  3000-4000€  (based  on  a  daily  rate  of  800€)  for  preparing,  sending  and  following  up 
(discussions  with  the  consultant  appointed  by  the  Commission,  further  follow  up)  of  a  well  prepared 
application  is  closer  to  reality;  this  figure  could  be  even  lower,  taking  into  account  that  exemptions 
affecting several producers are requested in a joint effort. Concerning distribution of costs across EEE 
sectors, although the electrical & electronic components that contain the hazardous substances (and for 
which  exemptions  are  requested)  are  used  in  almost  all  kinds  of  EEE  categories,  it  is  reasonable  to 
expect  that  most  applications  will  come  from  sectors  with  high  innovation  rates,  like  the  ICT  and 
consumer products sectors; this is confirmed by direct communications with industry representatives. 

EN 

37 

   EN 

 
                                                 
5.3.1.3.  Maintain  the  exemptions  procedure  with  changes  in  the  criteria  for  granting  and 

withdrawing exemptions and in the procedure for granting exemptions 

Introduce requirement for analysis of substitutes; 

Introduce broader criteria for granting exemptions; 

Introduce standard format and validity period. 

(a) 

(b) 

(c) 

Benefits: 

•  Poorly  substantiated  and  unjustified  requests  have  negative  impact  on  the  speed  of  the 
exemption  process:  approximately  70%  of  the  submitted  requests  to  date  were  rejected 
while provoking costs, wasting effort and causing delays in the treatment of the remaining 
justified  30%.  A  requirement  for  more  comprehensive  information  from  the  applicants 
reflected, if possible, in a substitution plan would filter out unsubstantiated requests. As a 
result, it would free resources for processing  of the other requests, improving the quality 
and  speed  of  the  process  and  thereby  reduce  administrative  burden  for  Member  States' 
administrations,  Commission  services  and  manufacturers,  in  particular  those  who  submit 
justified and well substantiated requests, which will be accepted much more quickly than 
in the past. 

•  Currently  RoHS  accepts  as  reasons  for  granting  an  exemption  technical  or  scientific 
impracticability  of  substitution  and  the  demonstration  that  substitution  would  bring  more 
environmental/health  disadvantages  than  the  banned  substance.  Taking  into  account  in 
addition  the  availability  and  reliability  of  substitutes  avoids  negative  socioeconomic 
effects, such as steep price increases or distortion of competition, withdrawal of products 
or  deterioration  of  quality  of  products  or  services  (for  example  medical  equipment  and 
health care services). 

•  A  standard  format  would  reduce  administrative  burden  for  manufacturers  given  that  it 
makes it easier for them to know what to submit in the request for exemptions; design of a 
request  for  exemption  is  reported  to  account  for  >50%  of  the  burden  related  to  the 
exemption procedure. 

Costs: 

•  In  cases  of  technical,  scientific  or  economic  uncertainty  as  to  when  substitution  can 
actually  take  place,  detailed  substitution  plans  may  prove  hard  to  draw  up  and  a  legal 
requirement to produce them would be too burdensome, if it is not flexible enough to take 
this into account; this is why the substitution plans will not be systematically required .  

•  The costs for analysing alternatives to HS range from 4300€ to 57000€

38, depending on the 
available  data  on  the  HS  to  be  substituted,  the  specific  application,  and  the  depth  of 
analysis  required  for  the  substitution  plan.  Integrating  a  requirement  for  analysing 
substitutes in RoHS should not incur any significant additional costs in the medium term, 
because economic operators will have to get acquainted with the REACH procedures and 

38 

http://ec.europa.eu/enterprise/reach/docs/reach/REACH_TAC_summary_report_final_19122006.pdf 
table 1, p.18 

EN 

38 

   EN 

 
                                                 
establish  mechanisms  internally  and  for  cooperation  (e.g.  on  sharing  of  data)  with  each 
other for fulfilling those at a reduced cost. 

•  It  may  prove  hard  to  collect  data  to  adequately  support  claims  of  lack  of  reliability  or 
availability  of  substitutes  for  requesting  an  exemption  which  would  lead  to  increase  of 
administrative  burden  for  manufacturers  (submitting  the  exemption  applications)  and 
Commission  services  and  Member  States  authorities  (who  have  to  evaluate  them  in  the 
Regulatory Committee). 

5.3.2.  Adapt product coverage to technical and scientific progress 

5.3.2.1.  Remove all products from scope of ROHS – repeal ROHS 

Benefits: 

•  Manufacturers  would  avoid  some  ongoing  costs  of  RoHS.  Where  manufacturers  have 
already  complied  with  RoHS  and  products  have  been  redesigned,  the  future  yearly  costs 
are  relatively  small:  estimated  at  0.04%  of  turnover39.  This  would  be  the  maximum  cost 
avoided,  but  the  costs  actually  avoided  will  depend  on  the  extent  to  which  industry 
switches back to using the HS  

•  If industry makes voluntary agreements not to return to those substances, repealing RoHS 
might  help  reach  the  policy  objectives  in  a  more  cost-effective  way;  (for  example,  the 
medical industry has already created an eco-design standard), however administrative costs 
from  implementing  any  voluntary  agreements  and  reporting  under  those  agreements  is 
likely  to  be  similarly,  or  perhaps  more,  burdensome  for  manufacturers  compared  to  the 
ongoing administrative costs from RoHS. 

•  The  upfront  costs  incurred  by  industry  for  RoHS  compliance  (understanding  and 
implementing  the  legislation,  capital  expenditure  and  operating  costs  for  making  the 
necessary changes in the production process) would not be saved by repeal. Although most 
manufacturers  have  not  calculated  the  cost,  industry  (for  products  currently  included  in 
RoHS)  estimates  it  would  vary  from  1-4%  of  turnover40.  More  recent  surveys  give  an 
average  overall  cost  related  to  RoHS  of  1,9%  of  turnover  (past  cost  and  one-off  future 
costs).  

•  Yearly  administrative  costs  (in  particular  verification  of  compliance)  make  up 
approximately  67%  of  total  costs,  while  the  share  of  technical  costs  amounts  to  33% 
(expected  to  drop  to  12%  in  the  future).  The  most  important  administrative  cost  is 
compliance  verification,  which  is  an  ongoing  expense.  There  are  few  data  and  many 
uncertainties  about  actual  cost  impact  of  RoHS  but;  assuming  the  total  number  of  EU 
companies affected by RoHS to 87,000, we come up with an extremely large range of 165 
to 23000 million €, corresponding to 0.042 to 5% of  the total turnover of EU companies 
affected by RoHS. 

•  Repeal  would  remove  the  administrative  costs  from  RoHS  implementation  for  national 
administrations  (staff  training,  awareness  raising,  market  surveillance  involving  purchase 

39 

40 

Arcadis report, p.101; the sample of companies is small ( 30 companies) but category 8&9 products are 
well represented 
ERA report, p.30, 150 

EN 

39 

   EN 

 
                                                 
of  analytical  instruments  and  of  products  on  the  shelf  for  checking  product  compliance, 
additional staff expenses). Ireland reported monitoring costs of 10 000 € in 2007 41. 

Costs: 

•  As there is no guarantee that voluntary efforts will deliver the same results as legislation 
(for example there is no information on how the abovementioned eco-design standard for 
medical  devices  is  applied  and  to  which  reductions  of  use  of  HS  it  has  led),  the  worst 
potential environmental impact of this option would be the return to use of HS in EEE and 
subsequent increase of environmental exposure. 

•  Manufacturers  might  start  using  again  the  banned  substances,  for  cost  reasons. 
Researchers42 conclude that lead-free soldering creates additional costs for EEE producers. 
If  return  to  the  banned  substances  takes  place  in  a  large  scale,  the  exposure  to  HS  from 
EEE  will  most  probably  increase  substantially,  if  there  is  no  clear  increase  in  WEEE 
separate collection and state-of-the art recycling. 

•  The  actual  extent  of  this  environmental  harm depends  on  the  return  to  use  of  HS.  As  an 
illustration, the Arcadis study reports, for selected products not covering the whole scope 
of  RoHS,  that  thousands  of  tonnes  of  heavy  metals  and  hazardous  flame  retardants  have 
been avoided from being used in EEE (see Annex I). 

•  For estimating the net environmental cost (expressed in tonnes of HS avoided from being 
used in EEE) one would have furthermore to consider that the volumes of EEE have risen 
(and  continue  to  rise)  significantly  but  also  that  some  uses  of  these  substances  could  be 
restricted by REACH in the future. Yet, neither EuP Directive nor REACH would provide 
the same level of protection from HS in EEE. 

•  Substances  that  are  relevant  for  RoHS  (used  in  some  cases  in  low  or  very  low  amounts, 
large share of imported products) may not be a priority for REACH, which does not aim to 
meet  the  RoHS  objectives.  Authorisation  under  REACH  captures  incorporation  of 
substances  into  articles  only  if  this  is  done  inside  the  EU,  thus  potentially  reducing 
protection from imported products. Should restrictions on whole groups of substances used 
in  EEE  (e.g.  PBBs  or  PBDEs)  be  deemed  necessary,  they  can  be  made  more  easily  via 
RoHS. Given the potentially different priorities and the inevitably limited working capacity 
of  the  authorities  involved  in  REACH  implementation  and  enforcement,  RoHS  offers  a 
quicker way for taking the necessary measures in relation to the protection of health and 
the environment from the hazardous substances contained in EEE.  

•  EuP  either  cannot  ensure  the  same  level  of  protection:  it  works  through  implementing 
measures  and  a  great  number  of  those  would  be  needed  if  one  wanted  to  cover  the  EEE 
currently covered by RoHS. EuP has a quantitative threshold (200 000 units of the product 
placed  in  the  market  yearly)  for  triggering  implementing  measures;  this  would  leave, 
among others, many medical devices out of the reach of implementing measures. 

41 
42 

Arcadis report, p.17 
Explorative  study  into  the  Sustainable  Use  and  substitution  of  soldering  metals  in  Electronics, 
O.Deubzer,  PhD  Thesis,  p.  178  –  180;  the  total  additional  ownership  cost  for  lead  free  soldering 
worldwide amounts to approximately 3 billion €; material cost amounting to approximately to 1,34 and 
opportunity cost to 1,9 bn € respectively. 

EN 

40 

   EN 

 
                                                 
•  Repealing RoHS would also be likely to have negative impacts on the internal market and 
competitiveness  of  business  due  to  risk  of  unilateral  restrictions  by  Member  States  and 
damage to increased recycling43  

•  Repealing  RoHS  would  furthermore  have  far  reaching  impacts  on  research  to  undertake 
efforts for substituting HS in new and existing applications as well as on orientations of the 
research  community  to  support  such  efforts  (possible  loss  of  jobs  for  highly  qualified 
scientists/technicians). This increases the costs of any future removal of HS both in the EU 
and globally 

•  Stakeholders  have  known  RoHS  for  the  past  years  as  the  stand-alone  legal  instrument 
regulating  HS  in  EEE;  this  includes  industry,  which  after  long  efforts  is  increasingly 
understanding  and  complying  with  RoHS  requirements.  Merging  RoHS  with  other 
instruments  would  most  likely  lead  to  inefficiency  concerning  the  achievement  of  the 
pursued aims and uncertainty, if not confusion among stakeholders44. 

5.3.2.2.  Make no changes, not include categories 8 and 9. 

Benefits: 

•  Continued flexibility for manufacturers to move towards reducing toxicity of their products 
at  their  own  pace;  categories  8&9  comprise  certain  complex  products,  the  functional 
characteristics  of  which  are  diverse  and  technically  demanding;  moreover,  due  to  their 
sensitive  character,  some  of  them  are  already  subject  to  customer  qualification  and  legal 
certification requirements. Relieving them from a possible additional RoHS-burden would 
allow  the  industry  to  use  fully  its  scarce  specialized  human  resources  for  developing 
innovative products. 

Costs: 

•  Discriminatory  treatment:  many  pro-active  manufacturers  have  already  substituted  the 
RoHS substances in many of their products, anticipating the forthcoming inclusion (Article 
6 of RoHS); some would stop substitution efforts if it were announced that these categories 
would  not  be  included  and  many  manufacturers  would  prefer  inclusion  (with  sufficient 
time to make changes) for avoiding unfair competition from free riders45. 

•  Risk of fragmentation of the market:: it can not be excluded that some Member States may 
follow  the  example  of  Norway  and  introduce  more  stringent  requirements  on  the  use  of 
substances at national level; this can be avoided by introducing categories 8&9 in RoHS. 

5.3.2.3.  Include all of Categories 8 and 9 with specific exemptions: 

NB: The ERA report as well as stakeholders contributions have stated that it is not technically 
feasible  to  include  all  of  Categories  8  and  9  in  the  scope  of  RoHS  without  exemptions  for 
specific applications of the banned substances. 

43 
44 

45 

Arcadis report p.130 
Arcadis report, part 5.2.1, p.97 : "…most companies have completed the changes required and are not 
requesting revisions…" 
ERA report, p.234 

EN 

41 

   EN 

 
                                                 
The elements provided by the ERA report on: 

– 

– 

The suitability of existing exemptions in the Annex of the RoHS Directive 

The need for additional exemptions, specific to category 8&9 products 

have  been  considered  and  updated  by  some  of  the  other  research  activities  carried  out  on 
behalf of the Commission services for supporting the review of RoHS and discussed in detail 
with the concerned industry. 

The result of this work is not further discussed in this Impact Assessment but reflected in the 
annex to the proposed Directive. 

(a) 

From 2012 

Benefits: 

•  Environmental benefit: Although use of some HS in categories 8&9 such as mercury has 
already  been  reduced  due  to  other  legislation46,  they  still  contain  several  tonnes  of  the 
heavy  metals  banned  under  RoHS  (>1400  tonnes  of  lead,  approximately  2,2  tonnes  of 
cadmium47)  which,  by  improper  waste  management  may  be  released  to  the  environment 
(only  49,7%  of  waste  medical  devices  and  65,2%  of  waste  control  and  monitoring 
instruments are separately collected48). Including these categories will further amplify the 
knock-on  effects  in  the  supply  chain  (accelerated  phasing  out  of  non-RoHS  compliant 
parts) and will facilitate implementation for the existing EEE categories. With this option, 
the environmental benefit is reaped at the earliest possible stage since manufacturers, even 
if  they  have  alternative  compliant  products  already  from  2007,  will  not  withdraw  non-
compliant products unless there is legislative pressure49. NGOs favour an early inclusion of 
categories 8&9 in RoHS, considering that phasing out of the HS is taking place to a large 
extent already (for some HS such as mercury also under the pressure of legislation outside 
the EU) and, given the anticipated inclusion by manufacturers, many products are already 
RoHS compliant. 

•  The table below indicates the expected environmental benefits (expressed as reduction of 
the  HS  present  in  cat  8&9  products)  of  the  various  options,  as  described  in  the  2nd 
consultation  (December  2007  –  February  2008)  document  of  the  Commission  services; 
Business  as  usual  (option  5.3.2.2)  is  compared  (in  the  graph,  the  business  as  usual  is  set 
equal  to  1),  inter  alia,  to  option  5.3.2.3  (a)  and  (b)  (options  3  and  2B  of  the  graph 
respectively)50. Option 2 of the graph does not foresee any exemptions and was considered 
impracticable  at  this  stage  (see  Annex  III)  but  gives  the  medium  to  long  term 
environmental  benefit,  taking  into  account  that  exemptions  are  provided  on  a  temporary 
basis and are to be repealed as soon as substitutes are available. 

46 

47 
48 
49 
50 

For example in the US, or recently in the EU Directive 2007/51/EC of the European Parliament and of 
the Council of 25 September 2007 amending Council Directive 76/769/EEC relating to restrictions on 
the marketing of certain measuring devices containing mercury 
ERA report, p.68, 235 
UNU Final report on the review of the WEEE Directive, August 2007, p.iv 
ERA report, p.237 
BIO  intelligence  study;  this  graph  does  not  take  into  account  the  cancellation  of  the  DecaBDE 
exemption, which would mean zero DecaBDE for all options, including BAU 

EN 

42 

   EN 

 
                                                 
1.2

1

0.8

0.6

0.4

0.2

0

• 

BAU (Option 1)

Option 2

Option 2B

Option 3

Option 4

Option 5

Option 6

LEAD 
[kg]

CADMIUM
[kg]

MERCURY 
[kg]

HEXAVALENT 
CHROMIUM [kg]

PBB and PBDE 
[kg]

•  Further analysis, to take into account impact of waste management methods on the possible 
release  of  HS  to  the  environment  reveals  that  even  in  the  most  optimistic  scenario  (90% 
recycling)  inclusion  fo  categories  8&9  in  the  scope  would  result  in  improvements  of  at 
least 50% for all 4 toxicity indicators used51; if current reported recycling rates (57%) are 
taken as basis, the medium to long term reduction would be up to 70% compared to BAU.  

•  RoHS  helped  companies  for  a  better  preparation  for  export  markets,  improved  the 
knowledge  of  EEE  composition  and  the  supply  chain  management,  as  well  as  the  global 
skill levels and the process control within companies resulting in some cases in monetary 
gains52; if categories 8&9 are included these benefits will accrue also to companies in these 
sectors, in particular those which have not taken any measures to reduce product toxicity 
yet  and  to  “SMEs  –  EEE  manufacturers”  which  will  benefit  from  wider  data  availability 
and  to  “SMEs  –  components  manufacturers”  which  will  benefit  from  even  greater 
harmonisation of the requirements of their customers in the EEE sector 

Costs: 

•  The cost of compliance for categories 8&9 could be as high as 7 – 10% of turnover due to 
the  additional  test  and  approval  costs.  In  the  case  of  modifying  an  existing  complex 
product, as some products in categories 8&9 are, the cost to make it RoHS compliant can 
be  up  to  20%  although  in  most  cases  it  will  be  less,  in  the  order  of  1-10%53.  In  spite  of 
intensive  efforts  it  has  not  been  possible  to  obtain  reliable  and  comprehensive  data,  the 
margin  of  uncertainty  remaining  high  (indicative  overall  compliance  costs  for  categories 
8&9 are estimated in the range of 400 to 1600million€) 54  

•  If some specific medical devices (in vitro diagnostics or active implanted medical devices) 
or industrial control and monitoring instruments are included already in 2012, a potentially 

51 

52 
53 
54 

BIO  intelligence  study;  the  indicators  used  were  human  toxicity  potential,  freshwater  aquatic, 
freshwater sedimental and terrestrial ecotoxicity potentials 
Arcadis report, p.130 
The figures are from the ERA report, p.237 and 150 respectively 
BIO intelligence study 

EN 

43 

   EN 

 
 
                                                 
high number of products will have to be withdrawn from the market because of technical 
impossibility of substitution. In their recent submissions specialised industry stakeholders 
support in principle the inclusion of categories 8&9 in RoHS but consider that doing so as 
of 2012 will lead to unacceptably high costs and withdrawal of certain products from the 
market due to the impossibility of RoHS compliance (losses of sales revenue estimated in 
the order of magnitude of billions of €) 55 

•  Possible  negative  impacts  on  health  care  :  the cost  increase  would  be  passed  on  to  users 
increasing  the  price  of  e.g.  sophisticated  medical  equipment  and  thus  making  advanced 
health care services less affordable to some patients' categories. The later the inclusion of 
certain types of products, the less is the likely impact on users, because this would allow 
manufacturers to fit substitution with existing resources and product development cycles; if 
the date of inclusion is earlier than 2012, average prices of some medical equipment could 
rise by 5%56 thus possibly resulting in negative effects on healthcare provision but this is 
unlikely to happen if inclusion takes place on 2012, which is considered a date by which 
the most complex medical equipment could be compliant57. Note that the equipment costs 
are usually only a small proportion of health care costs, with the majority being the staff , 
medication and infrastructure costs. 

•  Possible  uncertainty  and  costs,  associated  with  the  exemption  procedure;  although  costs 
incurred by the exemption procedure make up only 1% of the total cost related to RoHS, 
some stakeholders associate administrative burden to the perceived as lengthy exemption 
process  and  the  related  uncertainty.  More  exemptions  (probably  more  than  10)  will  be 
needed for 2012 in comparison to a later entry into force. 

(b) 

From 2014 

Benefits: 

•  The environmental benefit of this option would be as previously, but delayed by two years 

Costs: 

•  According  to  estimates  provided  by  manufacturers  (ERA,  p.149)  most  category  8&9 
products  could  be  compliant  already  in  2012,  taking  into  account  the  most  complex 
products without negative economic impact; including them in 2014 would unnecessarily 
delay  the  environmental  effect  of  the  Directive.  In  recent  position  papers  specialised 
industry  stakeholders  indicate  2014  as  the  preferred  date  for  medical  equipment  except 
IVD and AIMD. 

•  Due  to  the  long  life  cycles,  relatively  (compared  to  consumer  products)  small  numbers 
sold,  longer  research,  redesign,  validation  and  testing  periods,  the  compliance  cost  per 
product and its dependence on the enforcement date for categories 8&9 is higher. Choosing 
2014 as implementation date would present a  reduced risk  for cost increase compared to 
the previous option, because increase  of prices and removal of  products from the  market 
are due mainly to the limitation of resources and lack of profitability for marketing new, 
compliant products so quickly. This is illustrated by the expectances for degree of products' 

55 
56 
57 

Direct confidential submissions to the Commission services 
ERA report, p.236-237 
ERA report, p.149 

EN 

44 

   EN 

 
                                                 
compliance:  a  group  of  category  9  products  manufacturers  estimates  that  on  the  average 
<3%  of  products  will  be  non-compliant  if  entry  into  force  is  2018,  while  this  range 
(depending on product type) would be 10-30% for 2015 and 30-40% for 2012. Household 
instruments would comply by 95% already in 2012, while for some industrial equipment; 
this % for 2012 could be as low as 52%58. 

(c) 

Delayed inclusion of cat.9 industrial equipment (2015) 

Benefits: 

•  Due account is taken of higher technical complexity and need for reliability for industrial 
monitoring  and  control  instruments.  The  entry  into  force  will  take  place  with  minimal 
technical  and  other  (e.g.  withdrawal  of  products,  loss  of  jobs)  complications,  effects  on 
quality of services, innovation potential and competitiveness because it is possible to bring 
by  this  date  the  majority  of  industrial  category  9  equipment  in  compliance  within  the 
normal marketing cycles of companies. 

Costs: 

•  Possible  uncertainty  and  grey  areas  through  the  introduction  of  yet  another  distinction 
("industrial" vs. "household" products) leading to an increase of administrative burden; the 
use of an existing international standard was proposed for clarifying the differentiation but 
this  solution  does  not  enjoy  a  universal  support,  even  within  industry.  Such  uncertainty 
will  be  reduced  by  the  proposed  insertion  of  a  new  definition  for  industrial  control  and 
monitoring equipment. 

•  Producers  of  Category  9  products  estimate  that  the  cost  (loss  of  sales  because  of 
impossibility to comply and hence withdrawal from the market) would be 439, 246,3 and 
49,3  million  €  for  enforcement  dates  2012,  2015  and  2018  respectively.  They  consider 
2018 as an appropriate date for the inclusion of industrial products, to be properly defined 
in the revised RoHS. 

•  The  environmental  benefit  of  the  Directive  will  be  delayed  but  it  is  not  expected  to  be 
significant for this 3-year period, although Category 9 equipment not used in households 
accounts for almost 75 % of the total59. 

(d) 

Delayed inclusion of certain medical devices (IVD: 2016, AIMD: 2020) 

Benefits: 

•  Until  the  proposed  deferred  enforcement  date  of  2016  (2020)  manufacturers  will  have 
sufficient  time  to  bring  these  product  categories  into  RoHS  compliance  without 
jeopardising product diversity or reliability. Such an addition will contribute to the overall 
environmental benefit from including Category 8 products (for example, estimates for lead 
used in solders in IVD and AIMD are 6000 and 800 tonnes respectively, out of the 66 000 
tonnes used in category 8 equipment60. 

58 
59 

60 

Direct submissions of industry to the Commission services 
UNU  Final  report  on  the  review  of  the  WEEE  Directive,  August  2007,  information  from  Spain  and 
Hungary, % of weight 
ERA report, p.66 

EN 

45 

   EN 

 
                                                 
•  As  for  the  previous  option,  proposing  an  earlier  enforcement  date  for  this  type  of 
equipment  could  lead  to  a  too  high  %  of  withdrawal  of  products  from  the  EU  market, 
because  manufacturers  would  not  have  the  necessary  time  for  redesigning  and  testing 
products. Forcing a too early enforcement date would increase the overall compliance cost 
also because untimely withdrawal of products and this would lead to increases in cost for 
the health services (for example “cost per test” for IVD). 

Costs: 

•  The environmental benefit of the Directive would be delayed, although the HS quantities 

involved (in particular for AIMD) are low.  

•  Some  IVD  products  could  be  compliant  much  earlier  without  additional  cost  or  health 
risks;  given  that  a  more  detailed  differentiation  has  not  been  possible  on  the  basis  of  the 
available  information,  the  proposed  postponed  enforcement  date  benefits  also  products 
which do not need it. 

•  Specialized industry stakeholders agree to 2016 as an appropriate date for including IVD 
but  consider  that  AIMD,  due  to  their  critical  character  should  be  excluded  for  the 
foreseeable  future  from  RoHS,  2020  is  suggested  as  the  earliest  possible  date  for  the 
review of such an exclusion.  

•  Such a differentiated approach might give the wrong signal to industry and not provide the 
necessary motivation for substituting HS; if such substitution efforts are not undertaken in 
time, adaptation will be more difficult later, given the possibility of RoHS-like legislation 
spreading  around  the  world  and  the  decreasing  availability  of  non-compliant  parts  (how 
long can AIMD manufacturers rely on the availability of components with lead-solders?). 

5.3.3. 

Substances covered [article 6 of RoHS] 

Besides  the  already  regulated  substances  under  RoHS,  EEE  contain  other  HS.  Article  6  of 
RoHS asks the Commission to adapt the list of regulated substances on the basis of scientific 
facts and taking the precautionary principle into account. 

5.3.3.1.  Make no changes to the list of substances regulated by RoHS 

Benefits 

•  If no new HS would be banned under RoHS, this would leave more room for flexibility in 
further  reducing  toxicity  of  their  products  with  voluntary  instruments  (such  as  standards, 
lists  of  substances  of  concern)  stimulated  by  market  demand  for  more  environmentally 
friendly products; this would lead to an economic benefit because the redesign for reducing 
toxicity would be integrated in the normal product redesign cycles and no additional cost 
would be generated. 

•  For many of the substances that could be handled by RoHS, more information will become 
available in the forthcoming years due to the notification and registration requirements of 
REACH;  this  will  facilitate  decision  making  on  appropriate  risk  management  measures, 
including  restrictions  under  REACH  for  the  HS  satisfying  the  REACH  criteria  For 
industry,  wider  information  availability  throughout  the  supply  chain  will  reduce  cost  for 

EN 

46 

   EN 

 
implementing  voluntary  initiatives  or  regulatory  risk  management  measures,  if  and  when 
they are decided.  

•  No  additional  effort  required  for  getting  acquainted  with  requirements  for  new  HS  in 

RoHS and possible related exemptions. 

Costs: 

•  While  the  main  benefits  of  this  option  are  economic,  the  potential  costs  are  mainly  of 
environmental nature and pertain to potential damage to human health and the environment 
from the continued use of HS. The extent of these costs will depend on the future use of 
these HS in EEE. 

5.3.3.2.  Remove substances from the list of banned substances under RoHS 

The  only  banned  substance  for  which  available  information  justifies  examining  whether  it 
should be removed from the scope of RoHS is DecaBDE. 

Benefits: 

•  In view of the remaining uncertainties, there are studies ongoing to investigate toxicity of 
DecaBDE  and  its  degradation  to  other,  already  banned  PBDEs  such  as  octa-BDE  and 
penta-BDE. Removing DecaBDE from the list of banned substances would give more time 
to EEE manufacturers to prepare for a possible later substitution. 

•  Removing  DecaBDE  from  the  ban  would  give  more  time  to  assess  the  relevance  and 
concrete achievements of an ongoing industry initiative for checking DecaBDE emissions 
as regards EEE. It would give more weight to voluntary initiatives for phasing out the use 
of DecaBDE. 

•  DecaBDE manufacturers claim that the ECJ ruling only referred to procedural aspects and 
does not put in doubt the scientific and technical basis for exempting DecaBDE; in order to 
overcome the procedural hurdle, DecaBDE should be removed altogether from the list of 
banned  substances,  otherwise  there  would  be  unacceptable  costs  due  to  a  forced 
substitution and increased fire risks for consumers. 

Costs: 

•  Environmental: studies show that out of 22000 tonnes of DecaBDE used in certain EEE, 
179  tonnes  volatilise  into  ambient  air  during  service  life;  in  view  of  the  current 
uncertainties about toxicity and degradation to toxic products in the environment this could 
cause considerable environmental and health costs in the future;  

•  Discriminatory  treatment  :  many  pro-active  manufacturers  (including  large  electronic 
manufacturers)  have  already  replaced  DecaBDE  in  many  or  all  of  their  products  by 
substitutes.  At  least  some  of  the  substitutes  may  have  minimal  potential  adverse 
environmental  and  human  health  effects61.  Repealing  a  substitution  obligation  which  is 
apparently economically feasible and technically possible by safer substitutes would create 

61 

ECB study, January 2007, on the assessment of Deca-BDE substitutes by the Commission 

EN 

47 

   EN 

 
                                                 
legal  uncertainty  and  would  discourage  economic  operators  from  further  voluntary 
substitution efforts; 

•  In view of the recent ruling of the ECJ annulling the Commission Decision which allowed 
further  use  of  DecaBDE,  proposing  to  remove  DecaBDE  from  the  list  of  banned 
substances would create confusion among stakeholders 

•  Repealing  the  ban  is  very  likely  to  have  negative  impacts  on  the  internal  market  and 
competitiveness  of  business  due  to  risk  of  unilateral  restrictions  by  MS;  a  Member  State 
has already notified to the Commission its intention to ban DecaBDE in other applications; 
the  environmental  protection  agency  of  another  Member  State  has  clearly  indicated  its 
intention to implement immediately the ECJ ruling62 

5.3.3.3.  Add  new  substances  for  all  EEE,  in  the  scope  of  RoHS  but  with  exempted 

applications 

Benefits: 

•  Preparatory studies have indeed revealed the presence of other HS which potentially may 
need  to  be  managed  properly.  Possible  environmental  and  health  concerns  could  be 
anticipated at an early stage (see Annex II). The quantities used in EEE for some of these 
HS are quite large (tonnes/year in the EU: TBBPA: 40 000, DEHP:29 000), while some of 
these  HS  are  not  chemically  bound  additives  which  may  leak  to  the  environment  during 
use63. 

•  Environmental and health benefits from addressing additional HS through RoHS could be 
achieved  using  the  necessary  mechanisms  for  ensuring  and  checking  compliance  that 
should  be  in  place  already.  Some  of  the  substances  identified  as  possible  candidates  for 
RoHS have been under investigation for a long time as to their environmental and health 
impacts  or  have  even  been  proposed  for  restrictions  or  other  measures  at  national  or  EU 
level  (e.g.  TBBPA,  phthalates).  Restricting  them  under  RoHS  would  ensure  equal 
treatment in the internal market. The ban could be implemented with the necessary room 
for unavoidable uses via the exemption mechanism which could become more flexible and 
efficient  (see  options  outlined  above).  NGOs  claim  that  the  documented  health  and 
environmental  impacts  of  substances  such  as  all  brominated  flame  retardants,  phthalates, 
PVC and beryllium justify their inclusion in RoHS in the near future. 

Costs: 

•  The  risks  from  the  use  of  substitutes  of  the  substances  in  certain  applications  are  not 
sufficiently known. This is for example the case for the possible substitutes of TBBPA and 
HBCDD  and,  to  a  certain  extent,  of  phthalates.  The  potential  environmental  cost  from 
substitution  is  therefore  uncertain.  For  some  of  the  investigated  substances  the  small 
quantities  contained  in  EEE  would  result  in  disproportionately  high  burden  for  business 
and consumers. 

62 
63 

http://www.umweltbundesamt.de/uba-info-presse/2008/pd08-050.htm 
Ökoinstitut report 

EN 

48 

   EN 

 
                                                 
•  Too  little  information  is  available  about  cost:  even  in  cases  where  the  substitutes  or  the 
necessary design changes (for example use instead of PVC other polymers which need less 
or no plasticizers such as phthalates) are available and safe, these can be more expensive 
and  there  is  a  risk  that  imposing  restrictions  through  RoHS  would  create,  for  certain 
categories  of  EEE,  economic  cost  for  manufacturers  and  increase  considerably  product 
price  to  the  end  user.  The  overwhelming  majority  of  industry  stakeholders  is  against  the 
idea of adding new substances under RoHS and propose that the REACH mechanisms are 
used instead for addressing any risks that might be identified; in particular manufacturers 
of the chemicals used in EEE insist that it is not justified to add substances in view of the 
scarcity  of  information  on  environmental  risks  and  financial  consequences  from  the 
generalized use of substitutes.  

•  Four out of the five HS identified for further analysis for possible inclusion in RoHS at a 
later  stage  have  already  been  identified  as  possible  candidates  for  characterisation  as 
substances of very high concern under REACH; imposing at this stage a restriction through 
RoHS would create confusion among stakeholders 

EN 

49 

   EN 

 
6. 

COMPARING THE OPTIONS 

6.1. 

Options to clarify and simplify the Directive 

The table below gives a summary of the overall impact of each option, based on the analysis 
of costs and benefits in section 5. It also makes recommendations for selecting options 

Option  

Overall Impact 

(numbers refer to section 4) 

(based on analysis in section 5) 

Recommended 
Selection 

4.1.1.  Make  no  changes  to 
scope and definitions 

for  business  and 
Existing  problems 
authorities will continue or even increase. 

Reject 

4.1.2.  Create  an  independent 
scope for RoHS 

Reduction  of  administrative  burden. 
Harmonised 
improves 
implementation of Directive.  

scope 

Accept 

inclusion  of  spare  parts 
a)  Explicit 
improves 
Distributes 
clarity. 
responsibility for compliance more evenly  

Accept  a)  and 
b)  

life-time  of  EE 
b)  Allows  extended 
products  due  to  availability  of  suitable 
spare parts 

a)  &  b)  Benefits  for  Member  States  and 
legal 
manufactures  due 
certainty  

improved 

to 

Accept  

4.1.3.  Clarification  of  Spare 
Parts  

a) Explicit inclusion of spare 
parts 

b) "Repair as produced 
principle" 

4.1.4. Clarification of excluded 
equipment 

a) Insert in RoHS clause 
similar to WEEE Art 2.1 
(excluding equipment which is 
part of another type of 
equipment that does not fall 
within the scope) 

b) Insert in RoHS clause 
similar to WEEE Art 2.3 
(excluding equipment which is 
intended for specifically 
military purposes) 

EN 

50 

   EN 

 
 
 
 
 
 
 
 
4.1.5. 
definitions  

Adding 

modifying 

Adds  to  harmonisation  of  definitions  and 
legal  clarity.  Reduces  administrative 
costs.  

Accept  

Options  4.1.2,  4.1.4  and  4.1.5  were  widely  supported  by  stakeholders.  Most  industry 
stakeholders  opposed  the  introduction  of  a  definition  of  spare  parts  and  possible  associated 
administrative  burden.  The  recommended  option  consists  therefore  in  subjecting  the  parts 
explicitly  to  the  substance  ban  but  not  to  the  other  requirements  of  the  revised  RoHS 
Directive.  As  far  as  the  definition  of  "homogeneous  material  is  concerned,  the  Commission 
services believe that it is useful to introduce in the Directive the one provided in the Guidance 
document, for reasons of legal certainty. 

Summary: Options 4.1.2- 4.1.5 are recommended, resulting in: 

Creation  of  binding,  independent  lists  of  products  defining  the  scope  for  the  RoHS 
Directive 

Exclusion only of spare parts needed for repairing EEE lawfully placed in the market 

Exclusion of military equipment and of EEE which are parts of other products falling 
outside the scope of RoHS 

Adapting definitions to the "Marketing of products package" and adding definitions 
on category 8&9 products, and for "homogeneous material" 

6.2. 

Options to improve enforcement 

The table below gives a summary of the overall impact of each option, based on the analysis 
of costs and benefits in section 5. It also makes recommendations for selecting options 

Option  

Overall Impact 

(numbers refer to section 4) 

(based on analysis in section 5) 

Recommended 
Selection 

4.2.1.  Make  no  changes:  not 
add  provisions  aiming  at  better 
implementation 
and 
enforcement 

Problems with free movement of EE in 
internal  market  continue.  Continued 
administrative burden for both Member 
States and business.  

Reject 

4.2.2. Strengthen mechanisms to 
remove  non-compliant  products 
from the market 

Accept 

in 

hazards. 

Reduction  of  non  compliant  products 
reduced 
on  market, 
resulting 
environmental 
Increased 
synergies  with  other  EU  product 
in 
legislation, 
reduced 
resulting 
administrative  burden 
for  Member 
States  authorities  and  manufacturers. 
Promotes fair competition. 

EN 

51 

   EN 

 
 
 
 
 
4.2.3.  Harmonize  methods  for 
demonstrating compliance 

Include 

a) 
conformity 
assessment  procedures:  use  of 
standards,  self  declaration  and 
CE marking 

Include 

conformity 
b) 
assessment  procedures:  use  of 
standards,  external  verification 
and CE marking  

a) increased legal certainty and reduced 
administrative  costs  for  Member  States 
and  manufactures;  standardisation  can 
facilitate  demonstration  of  conformity 
and enforcement 

Accept a)  

Reject b) 

b)  leads  to  disproportionate  costs,  in 
particular for SMEs, and is not justified 
by the risk 

Promotion of harmonised implementation and enforcement of the Directive are major goals of 
the  RoHS  review.  It  is  also  an  important  concern  of  stakeholders,  in  particular  economic 
operators.  The  Commission  services  estimate  that  such  harmonisation  will  be  promoted  if 
RoHS  includes  provisions  for  market  surveillance,  EEE  conformity  assessment  by 
manufacturers  and  for  presumption  of  conformity  of  products  manufactured  in  accordance 
with EU harmonised standards. 

Such  provisions  will  also  contribute  to  the  achievement  of  the  environmental  objectives, 
reduce risks for distortion of competition among manufacturers and facilitate free movement 
of EEE in the internal market. 

The  Commission  services  also  consider  that  the  abovementioned  new  provisions  should  be 
coherent with other EU product legislation, in particular the recently adopted "Marketing of 
Products  Package"  because  not  doing  anything  and  let  potentially  diverging  compliance 
verification and checking practices proliferate will result in increase of administrative burden 
for both national administrations and businesses. 

Summary:  Options  4.2.2  and  4.2.3  a)  are  recommended,  for  introducing  all 
necessary provisions on the basis of the "Marketing of products package" concerning 
: 

– 

– 

– 

national market surveillance activities 

mechanisms for assessing the conformity of the product prior to its placing on 
the market based on the self declaration by the producer 

presumption of conformity of the product on the basis of harmonised standards 
and CE marking 

EN 

52 

   EN 

 
 
 
 
6.3. 

Options to adapt the Directive to technical and scientific progress 

6.3.1.  Exemptions 

The table below gives a summary of the overall impact of each option, based on the analysis 
of costs and benefits in section 5. It also makes recommendations for selecting options 

Option  

Overall Impact 

(numbers refer to section 4) 

(based on analysis in section 5) 

4.3.1.1.  Make  no  changes  to 
the exemption mechanism 

Problems with length and administrative 
costs of exemption procedure continued 

Remove 

4.3.1.2. 
the 
exemption  mechanism  from 
the Directive. 

Could hinder adaptation to scientific and 
technical progress. Reduced environmental 
benefit.  

Recommended 
Selection 

Reject 

Reject 

Maintain 

the 
4.3.1.3. 
exemptions  procedure  with 
changes  in  the  criteria  for 
granting  and  withdrawing 
in 
exemptions 
the 
procedure 
granting 
exemptions 

and 
for 

a) & b) Faster and more transparent 
procedure for granting exemptions. 
Encourages substitution efforts. 

Accept  a),  b) 
and c)  

b) avoids negative effects such as price 
increases, or withdrawal of certain products 
from the market  

(a) introduce requirement for 
analysis of substitutes  

c)  Faster 
increased legal certainty 

exemption  procedure 

and 

(b) introduce broader criteria 
for granting exemptions 

(c) introduce standard format 
and validity period 

The Commission services estimate that abolishing  the exemption mechanism would deprive 
the  Directive  of  the  necessary  flexibility  for  cases  where  substitution  is  not  possible 
immediately and for adapting it to technical and scientific progress; moreover, were this to be 
done at the expense of a reduced scope, an additional disadvantage would be a reduction of 
the environmental benefit. 

At  the  same  time  the  Commission  acknowledges  the  comments  in  favour  of  reducing  the 
administrative burden for both Member States and producers, for speeding up the process and 
further  increasing  its  transparency  and  legal  certainty,  in  line  with  requirements  of  the 
chemicals'  legislation  and  for  taking  into  account  broader  criteria  than  the  ones  currently 
included in the Directive for granting exemptions. 

EN 

53 

   EN 

 
 
 
While the standardisation of the  format  enjoyed a unanimous support,  industry stakeholders 
were against the substitution plan because it would increase the administrative burden while 
those  mostly  concerned  with  enhancing  the  environmental  effect  of  RoHS  resisted  the 
insertion  of  additional  criteria  because  they  would  be  too  difficult  to  evaluate  and  prolong 
rather than speed up the exemption process. 

The  Commission  services  believe  however  that  coherence  with  REACH,  which  has  very 
similar  provisions  concerning  substitution  plans,  will  also  ensure  synergies  for  economic 
operators,  thus  reducing  substantially  any  additional  cost  from  and  facilitating  the 
implementation  of the related  requirements in RoHS; furthermore refusing exemptions even 
when  substitutes  are  not  reliable  and  available  may  have  negative  environmental,  economic 
and social impacts. 

The  general  time  limitation  for  exemptions  increases  legal  certainty  and  has  been  explicitly 
supported  by  many  Member  States  during  informal  meetings  and  in  the  Regulatory 
Committee. 

Option 4.3.1.3 is recommended: 

– 

– 

– 

– 

Applicants  submit  an  analysis  of  substitutes  together  with  their  request  for 
exempting an application of the banned substance 

If availability or reliability of substitutes is not ensured, an exemption should 
be granted 

A  standard  format  for  requesting  an  exemption  should  be  established  (by  the 
regulatory Committee) 

Granted  exemptions  have  a  maximum  validity  period  of  4  years  but  can  be 
renewed 

6.3.2.  Adapt product coverage to technical and scientific progress 

The table below gives a summary of the overall impact of each option, based on the analysis 
of costs and benefits in section 5. It also makes recommendations for selecting options 

Option  

Overall Impact 

(numbers refer to section 4) 

(based on analysis in section 5) 

Recommended 
Selection 

4.3.2.1.  Remove  all  products 
from  scope  of  ROHS  –  repeal 
ROHS 

Damage to environment due to increased 
exposure to HS. Hinders recycling. 
Fragmentation of internal market 

Reject 

4.3.2.2.  Make  no  changes,  not 
include categories 8 and 9. 

Would penalise manufacturers and 
discourage substitution efforts. 
Fragmentation of internal market. 

Reject  

EN 

54 

   EN 

 
 
 
 
4.3.2.3. Include all of 
Categories 8 and 9 with specific 
exemptions: (a) from 2012 

a), c) & d): Environmental benefit from 
reduction of HS. Level playing field for 
manufacturers. 

Accept a), c) & 
d) 

Reject b) 

(b) from 2014  

(c) delayed inclusion of cat.9 
industrial equipment (2015)  

(d) delayed inclusion of certain 
medical devices (IVD : 2016, 
AIMD : 2020) 

b)Unnecessary delay for implementation 
of regulation and associated 
environmental impacts. 

c) & d) postponement for these specific 
sub-categories are justified. 

that 

The  Commission  services  estimate 
including  Categories  8&9  would  reduce 
environmental impacts from the presence of HS in these products. Equivalent environmental 
benefits would not be achieved by REACH, which focuses on substances rather than products 
and has its own prioritisation criteria, the EuP Directive which does not focus on toxicity of 
products  and  which  has  quantitative  thresholds  excluding  in  practice  many  products  of 
Categories 8&9 from its scope or by voluntary industry actions such as standards, the content 
and implementation of which do not necessarily reflect the policy objectives. Furthermore a 
continued exclusion would have negative economic repercussions. 

Maintaining  Categories  8&9  out  of  scope  would  possibly  avoid  certain  additional  costs  to 
some  manufacturers  but  would  be  detrimental  to  those  who  already  invested  in  substitution 
and in the medium and long run could be economically unfavourable to everybody, depriving 
the EU industry from the competitive advantage stemming from a better product and process 
control  and  adequate  preparation  for  facing  environmental,  including  reduced  toxicity, 
requirements worldwide. 

While the available data do not allow a fully quantified comparison of the benefits and costs 
of bringing these products in the scope at the various possible enforcement dates, taking into 
account  that  it  is  technically  feasible  to  achieve  the  expected  environmental  benefit  without 
excessive costs already in 2012, the Commission considers this as the most appropriate option 
for  bringing  in  the  scope  medical  devices  and  non-  industrial  control  and  monitoring 
instruments. 

At  the  same  time  and  taking  into  account  the  specificities  of  some  of  Category  8  and  9 
products64  (safety  critical,  long  lifecycles,  long  product  development  not  least  because  of 
diverse  and  technically  demanding  functional  characteristics)  as  well  as  scientific  and 
technical development with regard to substitution of the substances in certain applications, it 
is considered necessary that some exemptions are granted65 and that the enforcement dates are 
staged  in  such  a  way  for  some  product  categories  so  that  negative  social  impacts  (reduced 
availability  of  products  due  to  forced  withdrawal  of  products  impossible  to  be  made 

64 
65 

ERA report, p. 27 
ERA report, p.242 – 245,  

EN 

55 

   EN 

 
 
 
 
                                                 
compliant, limitation of access to high quality health care due to disproportionate increase of 
medical devices' price) are avoided. 

Summary: The recommended options are the inclusion of, with the exemptions of 
the Annex to the Directive proposal: 

medical devices and non- industrial control and monitoring instruments from 2012 

industrial control and monitoring instruments from 2015 

in vitro diagnostics (IVD) from 2016  

active implanted medical devices (AIMD) from 2020  

6.3.3. 

Substances covered [article 6 of RoHS] 

The table below gives a summary of the overall impact of each option, based on the analysis 
of costs and benefits in section 5. It also makes recommendations for selecting options 

Option  

Overall Impact 

(numbers refer to section 4) 

(based on analysis in section 5) 

Recommended 
Selection 

4.3.3.1.  Make  no  changes  to 
substances 
of 
list 
the 
regulated by RoHS 

Manufactures will have greater flexibility. 
Lack of sufficient scientific and market 
information to justify changing the list  

Accept 

4.3.3.2.  Remove  substances 
from 
list  of  banned 
substances under RoHS 

the 

DecaBDE only substance concerned. 
Potential environmental and health risks. 
Substitutes exist.  

Reject  

4.3.3.3.  Add  new  substances 
for  all  EEE,  in  the  scope  of 
RoHS  but  with  exempted 
applications 

Lack of sufficient scientific and market 
information to justify adding new 
substances 

Reject  

Considering  the  available  evidence  (Ökoinstitut  report,  stakeholder  consultations  in 
connection  with  this  report,  bilateral  contacts  with  industry  and  other  stakeholders)  the 
Commission services conclude that: 

•  Beyond the HS already regulated by RoHS, EEE contains other HS and it is necessary to 

manage the risks emanating from their use in EEE. 

•  There seem to be substitutes in many applications of these HS in EEE but they are either 
insufficiently  investigated  as  to  their  potential  environmental  and  health  impacts,  or  too 
expensive to apply in all EEE covered by the RoHS scope, or both. 

EN 

56 

   EN 

 
 
 
 
For  the  abovementioned  reasons  the  Commission  services  do  not  consider  appropriate  that 
new  HS  are  added  to  the  scope  of  RoHS  but  will  continue  to  monitor  the  evolution  of 
knowledge  on  HS  in  EEE  not  regulated  by  RoHS  and  their  possible  substitutes  and,  if 
necessary, propose to add HS in the scope at the occasion of the next review of the Directive. 

Concerning  DecaBDE,  the  Commission  services  consider  that  the  remaining  uncertainties 
about  its  toxicity  and  degradation  to  other  banned  products,  as  well  as  the  commercial 
availability of substitutes justify maintaining the ban on this substance. 

No new hazardous substances added to the scope of RoHS at this stage 

6.4. 

Overall benefits and costs from the recommended options 

•  There  is  little  experience  of  actual  compliance  costs  in  industry;  for  products  currently 
included in RoHS, estimates are it would vary from 1-4% of turnover. More recent surveys 
give  an  average  overall  cost  related  to  RoHS  of  1,9%  of  turnover  (past  cost  and  one-off 
future costs).  

In  the  case  of  medical  devices  and  control  and  monitoring  instruments  some  of  which  are 
produced  in  low  numbers  or  have  critical  applications  and  hence  increased  testing  and 
reliability requirements, approximate yearly compliance cost is estimated to 400-1600 million 
€; it is even claimed that co st of RoHS compliance for some complex products could be as 
high as 7-10% of turnover (new product) or 1-10% (modification of existing product). A large 
part  of  this  cost  is  attributable  to  the  long  development,  testing  and  approval  cycles  of  the 
more  complex  products.  This  is  why  a  staged  introduction  for  these  products  is  proposed 
allowing the compliance conversion to take place in the framework of existing resources and 
product development cycles. 

The RoHS Directive does not foresee explicit reporting obligations for Member States or for 
information supply requirements by manufacturers in RoHS and in most cases Member States 
have  not  introduced  such  legal  obligations  at  national  level  either  for  manufacturers.  The 
process  for  granting  exemptions  is  considered  lengthy  for  products  with  short  innovation 
cycles;  harmonising  the  requirements  for  the  contents  of  the  application  and  clarifying  the 
period of validity of exemptions will speed up the process, increase legal security and reduce 
administrative burden for both authorities and the applicants.  

The  introduction  of  harmonised  requirements  for  scope,  definitions,  assessment  of  product 
conformity  and  market  surveillance  which  are  in  line  with  other  product-related  EU  legal 
requirements will increase legal certainty and thus reduce the administrative burden.  

Initial implementation of these revisions could create additional administrative burden for 
Member States and producers dependent on the Member State’s current level of preparation 
for  proper  enforcement  and  on  the  adequacy  of  measures  taken  by  producers  for  ensuring 
product compliance.  

The  Commission  services  estimate  that  overall  net  benefits,  albeit  modest,  will  ensue. 
Moreover,  the  recommended  options  will  have  an  important  cumulative  effect  in  clarifying 
the  Directive  and  harmonising  its  implementation  and  enforcement  with  a  positive 
contribution to better regulation. 

EN 

57 

   EN 

 
Environmental  benefits  are  likely  to  be  significant:  several  tonnes  of  the  heavy  metals 
banned under RoHS (>1400 tonnes of lead, approximately 2,2 tonnes of cadmium) are used in 
medical devices and control and monitoring instruments, which account for 0,2-03% of waste 
from  electrical  and  electronic  equipment  by  weigh;  these  substances  by  improper  waste 
management may be released to the environment (only 49,7% of waste medical devices and 
65,2%  of  waste  control  and  monitoring  instruments  are  separately  collected);  restricting  the 
use  of  these  substances  through  RoHS  will  in  the  medium  to  long  term  eliminate  their 
presence  in  the  products  and  in  the  waste  thereof;  further  analysis  shows  that  even  in 
scenarios  assuming  much  higher  recycling  rates  there  is  some  environmental  benefit  from 
including these categories of equipment in the scope of RoHS. 

Taking  into  account  that  current  Member  States'  checks  revealed  that  up  to  44%  of  EEE 
checked were not fully compliant, effective market surveillance mechanisms at national level 
and  enhanced  cooperation  among  Member  State  authorities  for  removal  of  non-compliant 
products  are  expected  to  increase  considerably  the  environmental  benefit  of  RoHS  by 
minimising the number of non-compliant products on the market.  

Concerning the adaptation of list of hazardous substances regulated by RoHS, the preparatory 
studies  identified  candidate  substances,  but  given  the  lack  of  sufficient  information  on 
substitutes, which does not allow a clear view on whether they are environmentally safer or, 
in  cases  where  environmentally  safer  alternatives  do  exist,  whether  replacement  costs  are 
proportionate  to  environmental  benefits,  it  is  not  considered  feasible  to  propose  new 
hazardous substances in the scope of RoHS. 

7. 

MONITORING AND EVALUATION 

7.1. 

Core indicators of progress towards meeting the objectives 

The  core  indicators  for  progress  towards  meeting the  objectives  set  for  this  policy  initiative 
are the following: 

(1) 

(2) 

(3) 

(4) 

Reduction  of  the  level  of  the  HS  regulated  by  RoHS  in  the  EEE  falling  under  its 
present scope  

Reduction of the level of the HS regulated by RoHS in medical devices, control and 
monitoring instruments. 

Overall  extent,  effects  and  efficiency  of  the  measures  taken  by  Member  States  to 
implement  RoHS  (for  example  via  number  of  product  checks  carried  out,  %  of 
compliant products, trends in reducing number of non-compliant products) 

Extent to which unnecessary administrative burdens are cut at EU and Member States 
levels to be evaluated via: 

(a) 

number  of  substantiated  complaints  from  economic  operators  about  non-
harmonized interpretation or enforcement of RoHS by Member States leading 
to avoidable cost 

(b) 

reduction of cost for conformity assessment for economic operators, 

EN 

58 

   EN 

 
(c) 

reduction of enforcement cost for authorities through improved administrative 
cooperation 

Stimulation of R&D efforts for substituting HS in EEE to be assessed by number of 
EU patents obtained in relationship to substituting HS in EEE 

Extent  to  which  the  RoHS  review  contributes  to  the  reduction  of  environmental 
burdens  and  health  problems  worldwide,  for  example  through  contributing  to  the 
promotion of less toxic and more environmentally friendly EEE, including through the 
adoption of legislation restricting the use of HS in EEE in other parts of the world or 
of  voluntary  instruments  (such  as  lists  of  HS,  voluntary  phase  out  of  non-regulated 
substances by individual companies, data bases, information and training of the supply 
chain on avoidance of HS in EEE) 

Reduction on number of voluntary marks for RoHS-compliance 

Promotion  of  use  of  harmonised  standards  for  presumption  of  conformity,  to  be 
evaluated  on  the  basis  of  adoption  of  harmonised  standards  related  to  RoHS 
implementation and of decrease in time needed to agree harmonised standards 

(5) 

(6) 

(7) 

(8) 

(9) 

Improvement of the exemption mechanism to be evaluated on the basis of: 

– 

– 

– 

Decrease in the time needed for granting an exemption 

Decrease in the number of exemption requests 

Decrease in the number of unsuccessful exemption requests 

7.2. 

Broad outline for possible monitoring and evaluation arrangements 

Taking  into  account  the  severe  difficulties  for  collecting  quantitatively  and  qualitatively 
meaningful data for carrying out the review (see section 1) it is suggested that the Regulatory 
Committee  determines  in  close  cooperation  with  stakeholders  specific  data  needs  and 
collection processes to monitor the progress made using the core indicators mentioned above. 
The details on the frequency and means of this reporting process will be left to the decision of 
the Committee. 

EN 

59 

   EN 

 
ANNEX I 

The environmental benefits of RoHS 

The  reduction  of  quantities  of  the  HS  banned  by  RoHS  contained  in  EEE  are  used  as  a 
straightforward and easily understandable indicator of its environmental benefit. Theoretically 
in order to calculate it, one would need to compare the HS quantities in EEE placed on the 
market before and after RoHS enforcement. 

However, the following should be considered: 

(1) 

(2) 

(3) 

(4) 

There is little information about the HS quantities used in EEE before RoHS and it is 
not  possible  to  elaborate  a  realistic  scenario  on  what  the  situation  would  have  been 
today (2008) if RoHS had never existed. 

Even  today  there  are  uncertainties  about  the  quantities  of  the  banned  substances  in 
EEE:  manufacturers  point  out  that  it  is  very  difficult  to  know  exactly  the  product 
composition in particular when it incorporates thousands of components from a long 
supply chain stretching around the world. 

There  are  uncertainties  about  the  quantities  of  EEE  placed  in  the  EU  market,  a 
necessary piece of information if one is to calculate the overall HS quantities.  

It is not always easy to determine to which extent the reduction of the HS in EEE can 
be attributed to RoHS or is due to other factors as well, such as technology changes or 
consumer preferences, or indeed other EU legal acts. 

The Arcadis study ("Study on RoHS and WEEE Directives", No30CE-0095296/00-09, March 
2008) carried out for the Commission services (Directorate General Enterprise and Industry) 
in  preparation  of  the  RoHS  review  calculated  (approximations)  the  quantities  of  the  banned 
substances avoided being present in EEE due to RoHS : 130605 tonnes of lead, 6251 tonnes 
of cadmium, 760 tonnes of hexavalent chromium, 31 tonnes of mercury and 18468 tonnes of 
Octa-BDE. 

TV  sets  are  an  illustrative  example;  Pre-RoHS  TVs  contained  (ranges  of  substances,  in 
grams): Lead : 2131-5473, cadmium : 125, DecaBDE : 452-1597, Octa-BDE:301-904. After 
RoHS the quantities are : Lead : 472-562, cadmium : 7-13, Octa-BDE : 0, Deca-BDE: 452-
1597 (when DecaBDE ban enters into force this will also be zero).  

By multiplying these figures with the average 35 million TVsets sold yearly in EU 25 one can 
calculate the absolute quantities of the substances.  

It has to be added that for lead a lot of the reduction is due not to RoHS but to technological 
change from cathode ray tubes to flat screens; taking this into account, it is estimated that the 
minimum amounts of lead in TVs avoided thanks to RoHS are in the order of 67 000 tons per 
year 

On the above basis, and taking into account the separate collection rates from the UNU study 
supporting  the  WEEE  review,  they  also  calculated  the  quantities  of  the  banned  substances 
avoided  being  disposed  of  and  potentially  released  into  the  environment:  89800  tonnes  of 

EN 

60 

   EN 

 
lead, 4300 tonnes of cadmium, 537 tonnes of hexavalent chromium, 22 tonnes of mercury and 
12600 tonnes of Octa-BDE. 

Key assumptions were the following:  

•  Out  of  the  whole  scope  of  RoHS,  only  the  following  products  are  considered: 
Refrigerators,  PCs  ,Laptops,  Printers,  Copiers,  Cell  phones,  TV  sets,  Watch/clocks, 
Fluorescent (double end) lamps, lawn mowers + gardening equipment.  

•  Video games and handheld video games, Dispenser for hot and cold beverages. 

•  Minimum benefit scenario i.e. minimum concentration of the HS in EEE before RoHS and 
minimum concentration after RoHS for the items with exemption and for the items without 
exemption after RoHS the presumed concentrations are based on the maximum allowable 
values :0.1 % by weight for Pb, Hg, Deca-BDE; 0.01 % for Cd and of 0 % for Cr(VI) and 
Octa-BDE.  

•  Technology changes or changes in the demand of product type after the implementation of 
RoHS  are  mostly  not  taken  into  account  in  the  determination  of  the  quantities  and  the 
further calculations, because there was often no detailed information. Only for PCs and TV 
sets  the  technology  change  from  a  cathode  ray  tube  before  RoHS  to  a  flat  screen  after 
RoHS was included. 

•  Reduction  in  Deca-BDE  presence  and  emissions  is  put  to  zero,  based  on  the  assumption 
that its use is allowed but from 30.06.2008 this will no longer be the case. It is estimated 
that approximately 22 000 tonnes of Deca-BDE are used yearly in the selected products. 

The overall environmental effects of lead substitution in solders have been largely discussed. 
Besides  the  positive  environmental  effects  of  substitution,  it  can  also  have  negative 
environmental  effects,  in  particular  energy  consumption.  However,  there  seems  to  be  no 
consensus  yet  on  energy  consumption  of  Pb-free  soldering  versus  Pb  soldering.  As  the 
discussion on the environmental impact of Pb-free soldering is very complex, ambiguous and 
still on-going, no definitive conclusion can be drawn on this topic yet. 

RoHS has generated additional environmental benefits as well which are probably even more 
uncertain to assess quantitatively but are nonetheless concrete and real: 

– 

– 

– 

– 

– 

stimulation of compliance throughout the supply chain affecting also EEE outside the 
RoHS scope (knock on effect). 

greater awareness about product composition and toxicity leading to better control of 
HS, including those not regulated by RoHS. 

similar legislation worldwide and hence increase of the market pressure for reducing 
EEE toxicity, beyond the elimination of the regulated substances. 

reduction of quantities of hazardous waste at the EEE production plants. 

reduction  of  health  and  safety  risks  stemming  from  the  use  of  these  substances  in 
production plants. 

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– 

reduction of environmental and health impacts during service life: Brominated flame 
retardants  tend  to  volatilise  from  products  during  service  life;  thanks  to  RoHS  the 
release of 150 tonnes of octa-BDE in the environment during use of EEE has been 
avoided (the quantities have been estimated per product/year; over the total lifetime 
of a product and for the number of products in the EU 25). With the entry into force 
of the ban, 179 tonnes of Deca-BDE should be added. 

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ANNEX II 

Additional hazardous substances used in electrical and electronic equipment 

The Commission services had a study carried out to determine which other HS are present in 
EEE, in which quantities, how their risks are managed and what could/should be done under 
RoHS (taking in particular REACH into account) if anything, to further reduce these risks. 

The contractor carried out an extensive consultation (overall duration three and a half months) 
with  stakeholders,  in  particular  industry,  to  determine  nature  and  quantities  of  HS  used  in 
EEE other than those regulated by RoHS. 

On the basis of the terms of reference, the contractor applied the following criteria to be used 
for the selection of HS to be further investigated:  

– 

– 

– 

– 

Substances meting the criteria for classification as dangerous according to Directive 
67/548. 

Substances meeting the criteria for classification as substances of very high concern 
(SVHC) in accordance with REACH. 

Substances which have been found as contaminants in humans and biota. 

Substances which can form HS during the collection and treatment of EEE. 

Based  on  these  criteria  and  after  extensive  stakeholder  consultations,  the  contractor  (Öko-
Institut) established the following list of (groups of) substances, for further assessment with 
regard to possible future inclusion in the RoHS substance ban: 

Tetrabromo bisphenol A (TBBP-A) 

Hexabromocyclododecane (HBCDD) 

Bis (2-ethylhexyl) phthalate (DEHP)  

Butylbenzylphthalate (BBP) 

Dibutylphthalate (DBP) 

Medium-chained chlorinated paraffins (MCCP) (Alkanes, C14-17, chloro) 

Short-chained chlorinated paraffins (SCCP) (Alkanes, C10-13, chloro) 

Nonylphenol ethoxylates 

Halogenated organic compounds 

These  preliminary  findings  as  well  as  the  need  for  additional  risk  management  measures 
under  the  RoHS  Directive  for  these  substances  in  light  of  (on-going  or  finalized)  Risk 
Assessments were discussed in a stakeholder workshop on 6 May 2008. The outcome of the 
stakeholder workshop can be summarized as follows: 

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Stakeholders  contested  the  relevance  of  certain  hazardous  substance  for  EEE,  due  to  the 
reported low quantities. 

Stakeholders  felt  that  'halogenated  organic  compounds'  is  too  broad  a  description  (many 
substances included) to be used as a basis for restrictions under the RoHS Directive. 

Concerning the substitutes -- although some information is available and it is settled that they 
do not present some of the hazards (such as, persistence, bioaccumulation or toxicity for the 
halogen-free  flame  retardants)  of  the  hazardous  substances  currently  in  use  --  stakeholders 
were  of  the  opinion  that  the  scientific  information  would  not  be  sufficient  to  establish  with 
certainty  that  substitutes  would  be  safer  for  environment  and  health  than  the  candidate 
hazardous substances of the list above. 

Some  stakeholders  pointed  out  that  phthalates,  used  in  EEE  mainly  as  plasticizers  in  PVC, 
may also be released out of the material into the environment during the life time of EEE. In 
this  case  for  many  EEE  applications  safer  alternative  substances  or  design  solutions  (use  of 
polymers  other  than  PVC  which  do  not  need  phthalates  as  plasticizers)  seem  to  exist  but 
stakeholders stated that they would not be fit for all EEE or would be too expensive. 

Taking into account the stakeholder comments, only the first five items of the above list were 
retained for more in-depth investigation. 

In spite of some additional data collected after the workshop, the study concludes that further 
investigation  of  technical  suitability,  (eco-)  toxicological  and  environmental  endpoints  of 
substitutes is necessary; limited information exists on environmental (e.g. energy use, toxicity, 
impact on waste stream), social (occupational health and consumer safety) impacts caused by 
substitution, on which costs will arise through a possible restriction of the proposed candidate 
substances  in  the  supply  chain  both  for  industry  and  consumers  or  the  competitiveness  of 
industry  on  the  internal  and  external  market.  Further  impacts  may  arise  from  administrative 
burden  (i.e.  information  and  verification  activities).  The  available  information  has  not  been 
specific enough to quantify the impacts mentioned above within the study. 

The  available  data  therefore  do  not  allow  to  decide  that  for  any  of  the  abovementioned 
candidate  substances  a  ban  under  RoHS  would  bring  more  important  environmental, 
economic  or  social  benefits  than  the  respective  costs  it  is  likely  to  incur,  therefore  it  is  not 
proposed to include any new hazardous substance in the scope of RoHS. 

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ANNEX III 

Options discarded at an early stage 

During  the  stakeholder  consultations  several  other  options,  not  analysed  in  section  5  were 
considered but rejected at an early stage. These are summarised below: 

Options to clarify and simplify the Directive 

Some  options  for  additional  definitions,  such  as  for  "fixed  installations",  "consumables"  or 
analytical description of the various product categories (including for example the "large scale 
industrial tools") have not been retained. Elaborating new definitions in these cases, some of 
which  are  highly  controversial,  could  prove  too  time  consuming;  it  is  doubtful  whether 
definitions  alone  would  solve  the  problem,  moreover,  the  current  "grey  area"  products  are 
rather few, in view of the overall scope of RoHS. It would be preferable not to undermine the 
efforts  made  to  date  for  clarifying  the  status  of  ‘grey  area’  products  but  rather  encourage 
efforts by stakeholders, in particular enforcement authorities in MS, to settle any remaining or 
emerging  cases;  this  will  be  facilitated  by  the  possibility  to  amend  one  of  the  annexes  by 
Comitology, as proposed in the present review. Available information does not justify either 
the  inclusion  of  electricity  generating  equipment  as  a  new  product  category  in  the  scope  of 
RoHS. 

Options to improve enforcement 

New  marking  has  been  almost  unanimously  rejected  by  stakeholders  and  does  not  seem 
indeed  to  bring  enough  benefits  to  counterbalance  the  visible  drawbacks,  such  as  risk  of 
confusion  from  proliferation  of  not  necessarily  easily  recognisable  marks  (taking  also  into 
account  that  EEE  are  subject  to  mandatory  labelling  under  the  WEEE  Directive);  this 
confusion  would  be  greater  if  the  marking  is  voluntary  (in  this  case  also  the  environmental 
benefit  would  be  reduced).  Furthermore,  any  additional  marking  (voluntary  or  obligatory) 
would entail some additional cost for industry. 

Some  stakeholders  supported  the  creation  of  a  stakeholder  forum;  this  would  represent  an 
additional step in decision-making that would probably slow down the process considerably 
(already  many  stakeholders  find  the  exemptions'  process  very  time  consuming).  The  added 
value  would  be  limited,  if  any,  since  sufficient  provisions  and  safeguards  for  stakeholder 
information and intervention are provided in the current RoHS. 

Options to adapt the Directive to technical and scientific progress 

•  Exemptions 

Other  options  examined  but  rejected  at  an  early  stage  included  removing  explicit  legal 
requirements  for  stakeholder  consultation  and  integrating  this  consultation  in  the  technical 
work  leading  to  positive  or  negative  recommendations  for  each  exemption  request  or 
submitting  directly  such  requests  to  the  Regulatory  Committee;  they  were  not  retained,  in 
spite of the apparent gains in expediency, because of the possible loss of transparency and the 
massive rejection by stakeholders. 

Granting  exemptions  only  for  new  technologies  or  only  for  new  equipment  would  probably 
pre-empt abuses of the process (unreasonable requests, same request submitted several times, 

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65 

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requests  for  applications  which  exist  long  enough  for  substitutes  to  be  in  place)  and  would 
leave  room  for  innovation  by  allowing  use  of  the  HS  in  new  applications  and  technologies 
whilst  not  considerably  damaging  the  overall  environmental  benefit  of  the  Directive. 
However, stakeholders in their vast majority are of the opinion that it would be too difficult to 
define  which  product  or  technology/application  is  "new"  or  "innovative".  The  Commission 
considers  that  the  risk  of  confusion  and  uncertainty  is  too  high  for  such  an  option  to  be 
retained. 

•  Adapt product coverage to technical and scientific progress 

Including  category  8&9  products  without  exemptions  soon  (e.g.  2012)  would  have  been 
impracticable while postponing the entry into force (e.g. until 2018) so that all these products 
may be included without a need for exemptions would mean an unnecessary postponement for 
the vast majority of products which are already compliant or close to substitution of the HS in 
question. 

Extending  the  scope  of  RoHS  to  cover  all  EEE  would  have  certainly  been  a  far  reaching 
amendment  and  did  get  support  from  several  stakeholders  (NGOs  and  MS).  Realizing  it, 
would enhance the environmental effect of the Directive in the medium term and remove any 
uncertainty  as  to  which  equipment  falls  under  the  scope.  However,  the  creation  of  the 
necessary negative list with exempted equipment (military equipment, aerospace applications, 
transport  equipment,  large  stationary  equipment)  might  lead  to  prolonged  discussions;  most 
importantly, the investigation of the full impacts of such an option cannot take place within 
the time schedule of the present review. Other options for clarification of the scope (related to 
fixed  installations  and  large  scale  industrial  tools)  were  mooted  but,  given  the  almost 
diametrically  opposed  views  of  stakeholders  and  the  lack  of  sufficient  data  for  evaluating 
them, it was decided to discard them. 

•  Substances covered [Article 6 of RoHS] 

Options  of  managing  risks  alternative  to  restrictions  of  use  have  been  considered:  waste 
management of EEE (thus reducing the release of HS in the environment); easy removability 
of parts containing HS (thus facilitating WEEE recycling and reducing release of substances 
during  the  end  of  life  phase).  Stakeholders  considered  them  at  most  as  part  of  the  solution; 
labelling  is  almost  unanimously  rejected,  since  it  is  deemed  likely  to  bring  confusion. 
Rejected were also the options aiming at simplification (choosing the time of entry into force 
of the ban in such a way that no exemptions are needed) because the availability of substitutes 
would not be necessarily ensured. 

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ANNEX IV 

Relations of the WEEE and RoHS Directives and coherence with other Community 
Policies or Legislation 

The  WEEE  and  RoHS  Directives  are  closely  linked  and  complement  each  other:  the  RoHS 
Directive  prohibits  the  use  of  certain  hazardous  substances  in  electrical  and  electronic 
equipment and thus facilitates the treatment of this equipment when it becomes waste.  

Coherence with general Community strategies 

The  objectives  of  both  Directives  are  in  line  with  relevant  Community  strategies,  including 
the Lisbon Strategy, the Sustainable Development Strategy, the Energy and Climate Package, 
the 6th Environmental Action Programme and its mid-term review, Integrated Product Policy, 
the Thematic Strategies on the sustainable use of natural resources and on waste prevention 
and recycling, the 'Marketing of Products' package and the Commission's recent lead market 
initiative. 

The  review  of  the  Directives  is  foreseen  in  the  Commission's  simplification 
programme, with implements the Community Lisbon Programme66. It will contribute 
to  eliminating  unnecessary  barriers  and  burdens  facing  European  business  and 
society, in line with the "growth and jobs" strategy of the EU. 

Both  Directives  contribute  to  the  reducing  CO2  emissions  through  energy  savings  from 
recycled  materials  and  thus  contribute  to  European  climate  reduction  targets  agreed  in 
Kyoto67. 

The  substance  ban,  design  requirements  and  waste  management  approach  of  the 
RoHS and WEEE Directives contribute to the objective of Thematic Strategy on the 
Sustainable  Use  of  Natural  Resources68  which  calls  for  lowering  the  overall 
environmental  impact  of  resource  use  in  a  growing  economy.  The  RoHS  Directive 
takes  account  of  this  by  allowing  exemptions  from  the  substance  ban  where 
“substitution  is  technically  or  scientifically  impracticable  or  where  the  negative 
environmental health and/or consumer safety impacts caused by substation are likely 
to outweigh the environment, health and/or consumer safety benefits thereof”69 and 
by  requiring  regular  reviews  of  the  substance  bans  in  the  light  of  scientific 
evidence70. The WEEE Directive responds to this by reducing the environmental and 
health impacts per unit of material used without restricting the use itself or limiting 
quantities. 

66 

67 
68 
69 
70 

The objective of the simplification exercise is to contribute to a European regulatory framework of the 
highest standards in respect of the principle of subsidiary and proportionality. Simplification intends to 
make  legislation  less  burdensome,  easier  to  apply  and  thereby  more  effective  in  achieving  its  goals. 
Following on these principles, a regulatory action should not be beyond what is necessary to achieve the 
policy  objectives  pursued,  needs  to  be  cost-efficient,  and  should  take  the  lightest  form  of  regulation 
called for. 
Prognos study, May 2008, http://www.prognos.com/Singleview.306+M5c828d79ff6.0.html. 
http://europa.eu.int/comm/environment/natres/index.htm 
RoHS Article 5 
RoHS Article6? 

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The  WEEE  and  RoHS  Directives  also  contribute  to  the  objectives  of  the  Thematic 
Strategy  on  Waste  Prevention  and  Recycling71  which  calls  for  less  waste  being 
generated  in  terms  of  toxicity  (“qualitative  waste  prevention”)  and  weight 
(“quantitative  prevention”),  and  for  an  optimization  of  recycling  in  view  of  overall 
environmental  and  health  benefits.  The  substance  ban  of  the  RoHS  Directive 
responds in particular to the call for “qualitative prevention”. The WEEE Directive 
responds to the aim of optimized re-use, recycling, and other recovery at a high level 
of environmental and health protection, giving planning security to economic actors 
through binding collection targets and harmonized standards for waste treatment. 

In  line  with  the  Integrated  Product  Policy  approach72,  the  RoHS  Directive  introduces  life-
cycle considerations as an essential criterion for granting exemptions.73 The WEEE Directive 
seeks to improve the environmental performance of all operators involved in the life-cycle of 
electrical and electronic equipment, e.g. distributors and consumers and treatment operators. 

WEEE  and  RoHS  contribute  to  the  objectives  established  by  the  6th  Environmental  Action 
Programme74 and its mid-term review75, which call, inter alia, for a significant reduction in 
the quantity of waste going to disposal and the volumes of hazardous waste produced while 
avoiding  an  increase  of  emissions  to  air,  water.  Moreover,  the  RoHS  Directive  explicitly 
refers  to  the  Sixth  Environment  Action  Programme  with  respect  to  future  decisions  on  the 
prohibition of additional hazardous substances under the RoHS Directive.76

Ensuring consistency with the “Marketing of Products” Package77 is particularly important in 
the  context  of  the  RoHS  review.  This  legislative  package  aims  to  simplify  and  improve 
existing  internal  market  legislation  on  goods,  by  providing  a  clear  and  consistent  legal 
framework which will at the same time guarantee safe products on the market. In the case of 
RoHS,  harmonised  definitions  and  obligations  for  the  economic  operators  could  lead  to 
substantial  economic  benefits  (reduction  of  administrative  burden  for  administrations  and 
producers) and more efficient and coordinated enforcement at Community level. 

The WEEE Directive is one of the policy instruments mentioned in the Lead Market initiative 
78  to  foster  recycling  markets,  help  more  and  better  recycling  yielding  environmental  and 
economic gains. 

Coherence with EU legislation on product design and waste management 

The  provisions  of  the  Directives  are  coherent  with  the  requirements  of  other  pieces  of  EU 
legislation on product design and waste management as explained below. 

71 
72 
73 

74 

75 
76 
77 
78 

http://europa.eu.int/comm/environment/waste/strategy.htm  
Reference IPP 
Exemptions  from  the  substance  ban  are  allowed  where  “substitution  is  technically  or  scientifically 
impracticable  or  where  the  negative  environmental  health  and/or  consumer  safety  impacts  caused  by 
substation are likely to outweigh the environment, health and/or consumer safety benefits thereof. 
Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down 
the Sixth Community Environment Action Programme OJ L 242, 10.9.2002, p. 1–15.  
COM(2007) 225 final. 
Article 4(3) of RoHS. 
Add reference when published. June? 
COM (2007)860 final 

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RoHS and REACH 

REACH79 aims to create an EU-wide system for the management of chemicals and their safe 
use,  by  inter  alia  requiring  manufacturers  and  importers  to  gather  information  on  the 
properties  of  chemical  substances,  which  will  allow  their  safe  handling,  and  to  register  the 
information in a central database run by the European Chemicals Agency (ECHA). RoHS, on 
the other hand aims to contribute to the protection of human health and the environmentally 
sound recovery  and disposal of WEEE  and to  eliminate the disparities between the national 
laws of the Member States. To this end, it restricts the use of certain hazardous substances in 
electrical  and  electronic  equipment  put  on  the  Community  market.  Since  the  objectives  and 
approaches of both pieces of legislation differ, one cannot be replaced by the other but they 
complement each other. 

REACH confirms the importance of managing chemical releases related to waste treatment, 
which  forms  the  core  of  RoHS,  by  requiring  information  on  all  stages  of  a  substance's 
lifecycle to be provided for in the chemical safety report. It is based on the demonstrated risk 
of a substances resulting from its use, while RoHS is founded on a preventive approach, based 
on the hazard profile of the substances (as opposed to only demonstrated risk from their use), 
similarly  with  the  recent  Commission  proposal  for  the  revision  of  the  toys'  Directive. 
Currently,  should  a  substance  that  is  subject  to  authorisation  under  REACH  be  restricted 
under  the  RoHS  Directive  for  use  in  EEE,  such  application  will  be  exempted  from  the 
REACH authorisation requirements. 

However,  since  REACH  is  subsequent  to  RoHS,  and  much  wider  and  elaborate  in  scope, 
certain  provisions  of  RoHS  could  be  clarified  or  further  elaborated  upon  in  the  light  of 
REACH.  For  example,  it  could  be  clarified  how  the  link  to  REACH  should  be  if  further 
hazardous substances would be restricted under Article 4(3) of RoHS80 . Using the REACH 
model, it could be clarified in the RoHS Directive that producers requesting exemptions under 
RoHS should be required to provide relevant information on the available substitutes and their 
characteristics and, if possible, a substitution plan. Likewise, by June 2012, the Commission 
will carry out a review of the scope of REACH with a view to identify overlaps with other 
Community legislation that may exist and propose an amendment of the scope of REACH if 
appropriate. 

RoHS, WEEE and the EuP Directive 

The  "EuP"  Directive  (2005/32/EC)81  establishes  a  framework  for  the  setting  of 
ecodesign requirements for energy-using products.  

79 

80 

81 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, OJ L 396 of 30 December 2006. 
While  RoHS  simply  states  that  further  prohibitions  can  be  decided  based  on  available  scientific 
evidence,  and  the  substitution  of  those  substances  by  more  environment-friendly  alternatives  which 
ensure  at  least  the  same  level  of  protection  for  consumers,  without  providing  any  definition  of  these 
criteria, REACH provides for a detailed risks identification for substances and their substitutes. 
OJ L 191, 22.7.2005, p.29. 

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On  the  basis  of  the  EuP  Directive,  the  Commission  could  set  specific  eco-design 
requirements  for  EEE  which  may  also  be  covered  by  the  WEEE  and  RoHS 
Directives. 

However,  the  EuP  Directive  aims  at  improving  the  overall  environmental  performance  of 
selected  groups  of  EEE,  while  considering  economic  feasibility.  Reducing  toxicity  of  the 
product, e.g. by avoiding hazardous substances could be considered but restricting the use of 
substances is not an aim of the Directive. EuP was not meant to substitute specific legislation 
(otherwise REACH would contain a reference to it, as far as EuP products are concerned) but 
to ensure that sectoral/specific legislation is applied in a coherent and efficient way, for the 
benefit of the environment and the internal market.  

To the contrary, the RoHS Directive aims primarily at avoiding the banned substances for all 
EEE  within  its  scope.  Exemptions  are  only  possible  if  substitution  is  technically  or 
scientifically  impracticable  or  where  the  negative  impacts  of  substitution  outweigh  the 
positive  ones  As  regards  the  hazardous  substances  the  RoHS  Directive  therefore  provides  a 
more  direct  protection  of  the  environment  and  human  health.  RoHS  may  not  result  in  a 
negative  impact  on  the  overall  environmental  performance;  it  has  direct  (in  the  exemption 
process) and indirect (to chemicals policy, REACH) references to the life cycle environmental 
effects of substitution which need to be overall positive. 

There is a need to avoid ambiguity for those EEE potentially covered by all three Directives. 
With regard to substances banned by the RoHS Directive, ambiguity is avoided because the 
EuP  Directive  applies  without  prejudice  to  the  RoHS  Directive.  With  regard  to  the  WEEE 
Directive ambiguity could arise as concerns the general requirement of the WEEE Directive 
for  Member  States  to  encourage  design  for  recycling  (Article  4  of  the  WEEE  Directive). 
However,  since  this  is  a  general  requirement,  it  should  be  seen  as  addition  to  any  specific 
design requirements developed under EuP. 

RoHS, WEEE and specific EU waste management legislation 

The WEEE and RoHS Directives apply without prejudice to Community legislation on safety 
and  health  requirements  protecting  all  actors  in  contact  with  WEEE  as  well  as  specific 
Community  waste  management  legislation,  such  as  the  Battery  Directive82  and  the  End-of 
Life Vehicles Directive83. 

The Commission has clarified the links between these pieces of legislation in several guidance 
documents.  For  example,  with  respect  to  restrictions  on  the  use  of  hazardous  substances, 
batteries  are  covered  by  the  provisions  of  the  Batteries  Directive84;  not  by  the  RoHS 
Directive. Batteries are only covered by the requirements of the WEEE Directive where they 
are  still  included  in  EEE  at  the  moment  of  discarding.  EEE  is  covered  by  the  End-of  Life 
Vehicles  Directive  where  specifically  designed  to  be  used  in  vehicles,  otherwise  they  are 
covered by the WEEE and RoHS Directives. 

WEEE and general EU waste management legislation 

82 

83 
84 

Recital  10  and  Article  2  (2).  It  also  required  the  'old'  Battery  Directive  to  be  revised  in  light  of  the 
WEEE Directive, recital 11. 
ELV reference 
OJ L 266, 26.9.2006, p.1 

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The WEEE Directive is coherent with general EU waste management legislation, such as the 
Waste Framework Directive,85 the Landfill86 and Incineration87 Directives. It refers back to the 
general definitions set out in these Directives, for instance regarding the definition of waste 
and general waste management operations such as recovery and disposal88 and to the general 
provisions of the Waste Shipment Regulation.89 

85 
86 
87 
88 
89 

OJ L 114, 27.4.2006, p.9 
OJ L 182, 16.7.1999, p.1 
OJ L 332, 28.12.2000, p.91 
See Article 3 of the WEEE Directive. 
See Article 6 of the WEEE Directive. 

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GLOSSARY 

AIMD Active Implanted Medical Devices  

CA Conformity assesment 

DecaBDE DecaBromo- diphenylether 

EEE Electrical and electronic equipment 

EE Electrical and Electronic 

EuP Directive on the Eco-Design of Energy Using Products  

RoHS  Restrictction of Hazardous substances 

IVD in vitro dignostics 

HS Hazardous Substances 

HBCDD Hexabromocyclododecane 

MS Member States 

PBDEs Polybrominated diphenylethers 

PVC Polyvinyl Chloride 

REACH:  Regulation  on  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemical substances 

TBBPA Tetrabromobisphenol-A 

WEEE Directive on Waste electronic and Electrical Equipment 

DEHP : Bis(2-ethylhexylphthalate) 

NGO : Non Government Organisation 

ECJ European court of Justice 

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Annex V 

Assessment of the reduction of administrative burden 

In order to evaluate the overall cost of compliance to RoHS as a first step for calculating the 
expected  reduction  of  administrative  burden  from  the  recommended  options  in  the  review, 
several information sources were used (see also p.11) in particular : 

–  The ERA report  

–  The Arcadis Study 

–  The study made by the US-based Consumer Electronics Association (CEA) on the 

economic impacts of RoHS on the electronics industry 

–  UK Regulatory Impact Assessment on the transposition of RoHS Directive 

–  The "BIO Intelligence contract"  

In the context of the Arcadis study extensive consultation took place to identify and calculate 
RoHS  compliance  costs;  only  36  companies  responded  to  the  1st  and  2nd  round  of 
questionnaires. Most of them were large companies and in order to partly overcome the lack 
of SMEs (only 3) the results of 4 case studies from another project (GreenRose) were added, 
making  up  a  total  sample  of  40  companies.  The  majority  of  respondents  were  EEE 
manufacturers/assemblers, two companies manufacture components as their sole activity.  

The quality of the responses was diverse. Some companies only gave qualitative information. 
The interpretation of the data was often complicated by the fact that the provided figures in 
many cases  were incoherent. Moreover, only a limited number  of companies have provided 
turnover or employment figures. 

The  total  costs  include  the  so-called  "compliance  costs"  (getting  acquainted  with  the 
Directive’s requirements; provision of training and information to the different actors in the 
chain;  cost  of  collecting,  organising  and  reviewing  information  (e.g.  material  declarations); 
costs  related  to  exemption  procedures;  costs  related  to  organisational  implications  causing 
monetary  losses)  and  the  "technical  costs  of  phase-out  of  RoHS  substances"  (capital  and 
operating expenditure for the substitution, research and development to find, test and employ 
substitutes to replace the restricted substances. Compliance costs (apart from the last item on 
monetary  losses)  correspond  broadly  to  what  is  defined  as  "administrative  burden"  in  the 
impact assessment guidelines90; given however the absence of detailed information on each of 
the items of "compliance costs" it is considered that this approximation does not influence the 
conclusions. 

Administrative costs are defined as the costs incurred by enterprises, the voluntary sector, 

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public authorities and citizens in meeting legal obligations to provide information on their 
action or production, either to public authorities or to private parties. Information is to be 
construed in a broad sense, i.e. including costs of labelling, reporting, monitoring and 
assessment  needed  to  provide  the  information  and  registration.  In  some  cases,  the  information  has  to  be 
transferred to public authorities or private parties. In others, it only has to be available for inspection or 
supply on request. 

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On  the  basis  of  these  data  and  assumptions,  Arcadis  calculated  the  past  and  future  one-off 
compliance costs. Compliance costs make up 67% of total costs; the share of technical costs 
amounts to 33%. Within the future yearly costs to stay RoHS compliant, the share of technical 
costs  drops  to  12%,  whereas  compliance  costs  reach  a  level  of  88%  of  total  costs.  Future 
yearly costs amount to a maximum of € 4.7 mi llion, with an average of € 1.3 million and a 
weighted average of € 2.8 million.  

The most important compliance cost consists of compliance verification, which is an ongoing 
expense. When taking into account all compliance costs made in the past, almost half of it is 
dedicated  to  collecting  and  reviewing  information  activities.  41%  of  compliance  costs  is 
dedicated to training and information activities. 8% is dedicated to organisational implications 
causing monetary losses and 2% relates to exemption procedures. When only looking at the 
yearly  recurring  costs  expected  in  the  future,  the  share  of  costs  dedicated  to  compliance 
verification increases from 49% to 68%. The share of compliance costs dedicated to training 
and information activities falls from 41% to 26%. 

The "BIO Intelligence contract" summarised the available information and presented data 
from  additional  sources,  such  as  EUROSTAT  and  dedicated  Commission  studies  for  the 
engineering industry.  

The aim was to assess the administrative costs generated by the implementation of the RoHS 
Directive and their expected reduction thanks to the review. 

Given that administrative costs in available studies are rather expressed in €/company or % of 
turnover,  the  total  administrative  costs  due  to  the  RoHS  Directive  were  estimated  starting 
from the number of companies affected by RoHS and their turnover in the EU.  

The table below summarises the data found on administrative costs: 

Summary of available estimates of administrative costs 

Source 

Arcadis 2008 

CEA 2008 

Past costs and one-off future 
administrative costs 

Future yearly administrative costs 

€5,900,000/ company 
0.184% of turnover 

€286,000/ company 

€265,500/company 
0.042% of turnover 
€97,000/company 

It  is  clear  from  the  differences  observed  in  the  above  table  that  these  figures  must  be  taken 
with  extreme  care.  If  we  apply  them  to  an  estimate  of  15,000  (figure  from  statistics  on 
engineering  industry)  to  87,000  (Eurostat)  EU  companies  affected  by  RoHS,  we  obtain  the 
following  figures  (rounded),  on  the  basis  of  an  estimated  overall  turnover  of  approximately 
392 billion€ (Eurostat, EU 27, 2004) : 

Estimates of past and future administrative costs due to the RoHS Directive for 
European companies 

Source 

Arcadis 2008 

CEA 2008 

Past costs and one-off future 
administrative costs 
million euros 
89,000 – 513,000 (on the basis of cost 
/company) 
721 (on the basis of % of turnover)  

4,000 – 25,000 

Future yearly administrative costs
million euros 

4,000 – 23,000(on the basis of cost 
/company) 
165 (on the basis of % of turnover)  
1,400 – 8,000 

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If  we  focus  on  future  yearly  costs,  assume  the  87,000  figure  for  the  total  number  of  EU 
companies  affected  by  RoHS  is  the  best  estimate,  and  consider  only  cost  estimates  from 
[Arcadis 2008], we come up with an extremely large range of 165 to 23,000 million euros, 
corresponding to 0.042 to 5% of the total turnover of EU companies affected by RoHS. 

However,  due  to  the  low  overall  response  rate  to  their  survey,  the  sample  cannot  be 
considered  as  representative  and  cannot  be  used  for  extrapolation.  The  figure  of  265,500 
€/company  of  future  administrative  costs  is  onl y  valid  for  international  companies,  whereas 
the  percentage  of  0.042%  of  turnover  is  not  representative  either,  since  basically, 
administrative costs are proportionally higher for SMEs than for large companies. So neither 
165 nor 25,000 million€ can be considered accurate , because either under- or overestimated. 

It  therefore  appears  not  feasible  to  assess  the  total  future  RoHS-related  administrative  costs 
for European companies, as data available is not consistent enough.  

In  a  further  attempt  to  obtain  more  precise  information  regarding  the  impact  on  the 
administrative  burden  for  a  group  of  specific  options  (identified  as  options  which  could 
decrease the administrative burden of RoHS for companies), a short questionnaire was sent by 
BIO  to  some  major  industry  associations  but  too  few  responses  to  allow  any  meaningful 
quantitative conclusions were received.  

Based  on  the  view  of  industry  on  the  different  options  presented  in  the  questionnaire,  the 
reduction  in  administrative  costs  to  the  industry  is  expected  to  be  modest.  Nevertheless,  as 
pointed  out  by  some  of  the  respondents,  many  of  the  options  would  reinforce  the  current 
interpretations and practices and would thus support better regulation.  

Given the scarcity and lack coherence of data, other sources were also used in an attempt to 
get the best possible estimation of cost of compliance to the current RoHS and the impact of 
the  recommended  options;  in  particular  the  ERA  report  provided  some  input  for  medical 
devices and control and monitoring instruments; it states that for some complex products sold 
in small quantities cost might be as high as 7-10% of turnover, but this as well is based on 
estimates of an unspecified number of manufacturers (p.150). Assuming costs in the order of 
1-4%  of  the  turnover,  BIO  intelligence  estimated  the  yearly  compliance  costs  to  400-
1600million€ for categories 8&9. Date of entry into scope seems to be the main concern of 
manufacturers  and  to  have  an  important  impact,  although  difficult  to  quantify.  In  a  late 
submission,  the  medical  industry  claims,  based  on  a  sample  of  few  companies,  millions  of 
losses  (confidential  figures)  if  2012  instead  of  2014  is  chosen  as  an  enforcement  date.  For 
industrial test and measurement instruments, manufacturers claim that the estimated cost (loss 
of sales because of products which cannot be made RoHS compliant, even if exemptions are 
granted) would be 439, 246,3 and 49,3 million€ for enforcement dates 2012, 2015 and 2018 
respectively. For comparison purposes, the total sales revenue for a sub-group (test instrument 
categories only) is 1520 million € for the EU. It  should be stressed however that these figures 
have not been subject to any third party assessment, nor is it possible to weigh them against 
the expected increased environmental benefit of early enforcement date, which is very hard to 
calculate. 

In  the  Impact  Assessment  of  the  "Marketing  of  products  package"  some  cost  elements  are 
given which, although  general and pertaining to other regulated aspects of products such as 
safety and, to a certain extent, to products not covered by RoHS, do give an idea of the order 

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of magnitude of estimated cost from conformity assessment procedures (1-2% of overall unit 
production cost; for third party verification, cost could be as low as 500€, but would normally 
range  from  2500  –  3500€)  and  ma rket  surveillance  (industry  estimates  that  non-compliant 
products  cost  them  4-25%  of  their  annual  turnover;  increase  of  cost  by  5-10%  for 
administrations). Again it has to be stressed that the actual costs will depend on the degree of 
current  preparation  and  compliance  with  RoHS  and  that  subjecting  RoHS  explicitly  to  the 
same  requirements  and  procedures  as  for  other  regulated  aspects  will  create  synergies  and 
reduce  costs  (declaration  of  conformity  covering  many  regulated  aspects,  facilitation  of 
market surveillance). 

Finally, concerning the substitution plan, the Impact Assessment of REACH was used and the 
figures given in the analysis of options above are extracted from the below table  

Costs of analysis of alternatives at different levels of detail 

Level of detail 

Technical 

Level 1 
Level 2  
Level 3 

€ 875 
€ 2 188 
€ 8 750 

Costs of 
Alternatives 

HH & Env 
Hazard/Risk 

Total 

€ 1 750 
€ 8 750 
€ 35 000 

€ 1 750 
€ 10 938 
€ 13 125 

€ 4 375 
€ 21 875 
€ 56 875 

The possible administrative costs could be estimated on the basis of the above table, but these 
would of course vary considerably depending on what the actual substitution plan would look 
like and the substance/process in question. 

Use of the standard cost model 

Full calculation of administrative costs using the core equation of the cost model presented in 
the IA guidelines Annex 1091 was not possible due to absence of reliable and comprehensive 
data.  An  attempt  was  made  to  use  it  for  two  items  which  are  considered  most  relevant  and 
liable  for  quantification  that  is  to  say  demonstration  of  compliance  and  the  exemptions 
procedure. 

Concerning  the  exemptions  procedure,  the  Commission  services,  estimate  that  3000-4000€ 
(based on a daily rate of 800€) for preparing,  sending and following up (discussions with the 
consultant appointed by the Commission, further follow up) of a well prepared application is a 
realistic  figure.  The  Commission  services  have  received  approximately  140  exemption 
requests during the last 5 years, i.e. on the average 28 requests per year meaning a yearly cost 
to  applicants  of  84  –  112  000€.  Several  of  the  requests  were  submitted  or  followed  up  by 
industry  associations,  meaning  that  the  cost  has  not  been  borne  by  one  single  company  but 
spread among several. Even if we multiply the man/hours spent by factor 10, still the amount 
would  be  negligible,  compared  to  overall  turnover  of  the  EEE  industry  in  EU,  despite 
uncertainties and approximations. 

Administrative costs should be assessed on the basis of the average cost of the required 

91 
action (Price) multiplied by the total number of actions performed per year (Quantity). The 
average cost per action will be generally estimated by multiplying a tariff (based on average 
labour cost per hour including prorated overheads) and the time required per action. Where 
appropriate, other types of costs such as equipment or supplies’ costs will be taken into 
account. The quantity will be calculated as the frequency of required actions multiplied by the 
number of entities concerned. 

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The RoHS Directive does not foresee explicit reporting obligations for Member States or for 
information supply requirements by manufacturers in RoHS and in most cases Member States 
have not introduced such  legal obligations at national level either for  manufacturers. In  this 
respect,  a  strict  interpretation  of  the  "administrative  cost"  definition  could  lead  us  to  the 
conclusion  that  RoHS  does  not  create  any  administrative  burden  for  manufacturers,  as  far 
demonstration of compliance is concerned.  

Costs for testing may be significant but, as explained, in the majority of cases testing is not 
required;  in  most  cases  testing  costs  should  be  considered  as  cost  for  technical  compliance, 
hence  outside  the  definition  of  administrative  burden.  The  "RoHS  enforcement  Guidance 
Document" produced by the informal network of national authorities, although not binding, is 
largely  used  by  manufacturers.  Testing  of  a  single  component  may  cost  up  to  530€  but  full 
product  tests  according  to  international  standards  (ISO17025)  that  closely  follow  the 
guidelines  of  the  informal  network  are  available  at  630€.  However,  the  focus  of 
manufacturers'  effort  as  confirmed  by  direct  communications  with  manufacturers  and  the 
Arcadis  report  (p.104)  is  on  "collecting  and  reviewing  information"  primarily  from  their 
suppliers so as to make sure that the purchased parts are RoHS compliant. 

In  the  absence  of  more  detailed  information  on  the  actual  cost  for  producing  RoHS 
compliance documentation, the Commission services base their estimation on the relationship 
of cost of exemption request/collecting and reviewing information, which the Arcadis report 
estimated to 1/6. This would mean that, on the assumption that the annual cost for exemption 
request is 4000€ (see above) the annual cost  for compliance documentation would be 24 000€. 
Applying  the  87,000  figure  for  the  total  number  of  EU  companies  affected  by  RoHS  (see 
above), the result is approximately 2100 million€ for the EU.  

Conclusion 

The  analysis  in  Annex  V  shows  that  there  are  few  data  and  many  uncertainties  for  the 
calculation of the administrative burden incurred from RoHS, which seems to be low (or even 
negligible, if the administrative cost definition is strictly interpreted).  

It is therefore difficult to calculate the reduction of administrative cost that the recommended 
options will result in, but it is expected to be modest, albeit positive (for the reasons explained 
in  the  analysis  of  the  individual  recommended  options).  Nevertheless,  the  recommended 
options will have an important cumulative effect in clarifying the Directive and harmonising 
its implementation and enforcement with a positive contribution to better regulation. 

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