EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN 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 haza rdous substances in electrical and electronic 
equipment 
 
(recast) 
 
Summary of the Impact Assessment  
  
{COM(2008) 809 final} 
{SEC(2008) 2930} 
 
EN 2   EN SUMMARY  
RATIONALE FOR THE REVIEW 
Directive 2002/95/EC aims to restrict hazard ous substances in electrical and electronic 
equipment so as to contribute to the protect ion 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 co mmitted 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 impr ove 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 in clusion of two additional categories of equipment 
in the scope (categories 8&9 : medical device s and monitoring and control instruments) and 
the adaptation of the list of  restricted substances. 
PROBLEM AND OBJECTIVES  
Achievement of the RoHS Directive’s objectiv es is hindered and made more costly by 
problems related to uncertainties in implem entation 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 inconsiste ncy 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 monito ring instruments.  
The objectives of the review ar e: improved implementation and en forcement 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 stud ies were carried out. These dealt with the 
topics of the review as well as the policy optio ns within each topic. These consultations and 
studies helped define and an alyse 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 
 
EN 3   EN 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 cr eating 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 alre ady 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 pro duct on the basis of harmonised standards 
and CE marking. 
Adaptation of the procedure for exemptions,  for instance by intr oducing through comitology 
a requirement for applicants to analyse the substitutes before submitting a request, and the 
introduction of additional criteri a 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 rela ted to RoHS of 1,9% of turnove r (past cost and one-off future 
costs).  
In the case of medical devices and control an d monitoring instruments some of which are 
produced in low numbers or have critical ap plications 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% (modificati on 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 plac e 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 cas es Member States have not 
introduced such legal obligations at national le vel. The process for gr anting exemptions is 
considered lengthy for products with short i nnovation cycles; harmoni sing the requirements 
 
EN 4   EN for the contents of the application and clarifyi ng the period of validity of exemptions will 
speed up the process , increase legal security and reduc e 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 dependen t on the Member State’s current level of 
preparation for proper enforcement and on the ad equacy 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, approxima tely 2,2 tonnes of cadmium) are used in 
medical devices and control and monitoring in struments, 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 environm ent (only 49,7% of waste medical devices and 
65,2% of waste control and monitoring instrument s are separately collect ed); 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 ther eof; further analysis shows that even in 
scenarios assuming much higher recycling rates there is some environmental benefit from 
including these categories of e quipment in the scope of RoHS. 
Taking into account that curren t Member States checks reveal ed 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 remo val of non-compliant 
products are expected to increase considerab ly the environmental benefit of RoHS by 
minimising the number of non-compliant products on the market.  
Concerning the adaptation of list of hazardous s ubstances regulated by RoHS, the preparatory 
studies identified candidate substances, but gi ven the lack of suff icient information on 
substitutes, which does not allo w a clear view on whether they are environmentally safer or, 
in cases where environmentally safer alterna tives 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.