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) - Summary of the impact assessment {COM(2008) 809 final} {SEC(2008) 2930}
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) 2931 

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) 

Summary of the Impact Assessment 

{COM(2008) 809 final} 
{SEC(2008) 2930} 

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RATIONALE FOR THE REVIEW 

SUMMARY 

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. 

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 

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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. 

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: 

There  is  little  experience  of  actual  compliance  costs  for  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 

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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 
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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