EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN 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 haza rdous substances in electrical and electronic 
equipment 
 
(recast) 
 
Impact Assessment  
{COM(2008) 809 final} 
{SEC(2008) 2931} 
 
EN 2   EN TABLE OF CONTENTS 
EXECUTIVE SUMMARY........................................................................................................ 5 
INTRODUCTION................................................................................................................... ... 9 
1. Procedural issues and consulta tion of interested parties............................................ 12 
1.1. Organisation and timing............................................................................................. 12 1.2. Consultation and expertise ......................................................................................... 12 2. Problem Definition..................................................................................................... 15 2.1. Problems requiring action .......................................................................................... 15 2.2. Underlying drivers of the problems ........................................................................... 18 2.3. Who is affected, in what ways, and to what extent? .................................................. 19 2.4. How would the problem evolve , if no action is taken................................................ 19 
2.5. The EU right to act..................................................................................................... 22  
3. 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 provision s 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 
 
EN 3   EN 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 tec hnical 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 incl ude 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 provision s 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 tec hnical and scientific progress..................................... 39 
5.3.2.1. Remove all products from scope  of ROHS – repeal ROHS ...................................... 39 
 
EN 4   EN 5.3.2.2. Make no changes, not incl ude 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. Comparing the options ............................................................................................... 50 6.1. Options to clarify and simplify the Directive............................................................. 50 6.2. Options to improve enforcement................................................................................ 51 6.3. Options to adapt the Directive to technical and scientific progress........................... 53 
6.3.1. Exemptions.............................................................................................................. ... 53 
6.3.2. Adapt product coverage to tec hnical 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. Monitoring and evaluation ......................................................................................... 58 7.1. Core indicators of progress towards meeting the objectives...................................... 58 
7.2. Broad outline for possible monitoring and evaluation arrangements ........................ 59 
ANNEX I........................................................................................................................ .......... 60 
ANNEX II ....................................................................................................................... ......... 63 
ANNEX III...................................................................................................................... ......... 65 
ANNEX IV....................................................................................................................... ........ 67 
GLOSSARY....................................................................................................................... ...... 72
 
EN 5   EN 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 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 an d control and monitoring 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. 
 
EN 6   EN  
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, enfor cement 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 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: 
 
EN 7   EN • 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 tu rnover (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 
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 
 
EN 8   EN 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. 
 
EN 9   EN INTRODUCTION 
Background 
Electric and electronic equipment (EEE) is a product group char acterized by extreme diversity 
and increasingly fast innovation cycles. Its production supports  one of the fastest growing 
domains of manufacturing industry in the west ern world. In the EU alone an estimated 9,3 
million tonnes of EEE are sold annually, the bi ggest share of which are large household 
appliances and IT and telecommunication equipment. 
As the market continues to expand and in novation cycles become even shorter, the 
replacement of equipment accelerates, maki ng waste electrical and electronic equipment 
(WEEE) the fastest growing waste stream. WEEE ar isings 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 differen t materials and components, including several 
hazardous substances that can be  released into the environmen t and damage human health if 
not treated appropriately. Potent ial 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 ofte n supplied by illegal shipments of WEEE1. 
These risks can be significantly reduced by s ound management of WEEE. Elements of sound 
management include: separating WEEE from other wa ste to facilitate targ eted and technically 
adequate treatment, applying treatment standa rds 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 innovativ e design of EEE. This can  help to avoid to 
the extent possible the use of hazardous substa nces, reduce possible exposure of workers and 
consumers, and favour the efficient dismantling and sorting of waste. 
In principle, such an approach offers oppor tunities 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, incinera ted or recovered without pre-tr eatment. Some of the main 
reasons seem to include: 
– 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 linke d to individual producers; 
– Hazardous substances are often the cheapest technical solutions in the short term; 
                                                
 
1 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 – legisla tive 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.  
 
EN 10   EN – Inadequate disposal of WEEE has no extra costs or may even have price incentives 
(low-cost landfilling in many c ountries; illegal exports for sub-standard treatment); 
– Low prices for raw materials in previ ous decades discouraged investment in 
collection and recycling infrastructure. Even  the present raw materials prices enable 
profitable operations in the EU for only fe w waste materials and fears of cyclical 
price changes keep holding back investment. 
In reaction to this, in the late 1990s severa l Member States introduced national laws to 
address environmental concerns related to the management of WEEE. In 2000, the 
Commission proposed EU legislation in this fiel d, in response to rapidly growing amounts of 
WEEE and associated possible environmental and health problems, and to approximate 
product-related legislation acr oss 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 pos sible to recycle and 
recover it to reduce its disposal. It requires Me mber States to ensure that collection and 
treatment schemes are set up, sets collection and recovery targets, and makes producers3 
responsible for the financi ng of the WEEE management. So  far, no negative effects on 
consumption levels have been reported alt hough, during a transitiona l period, the costs of 
collection and treatment are clear ly indicated on new equipment.  The Directive thus enables 
market mechanisms and financial incentives in  favour of efficient co llection, treatment and 
“design for recycling”. 
The RoHS Directive prohibits the use of certa in hazardous substances in EEE, approximating 
national legislation across Member States to  ensure the free movement of goods. Its 
environmental objective is to protect humans a nd the environment against the release of these 
substances and to facilitat e recycling and recovery of materials from WEEE. While 
establishing binding minimum requirements for all producers, it enables competitive advantages for innovative products  and technologies th at can comply with the substance ban 
more efficiently. 
Recent research has confirmed th e rationale of the Directives
4. 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 re quires 85% less energy and recycled steel requires 74% less 
energy than the extraction and re fining of virgin materials. 
While the RoHS Directive contributes effectiv ely 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, rec overy and treatment of  WEEE will therefore 
remain necessary for the foreseeable future. 
                                                
 
2 Directives 2002/96/EC and 2002/95/EC respectively 
3 “Producers” are manufacturers of EEE in the EU as  well as first-time importers of EEE into the EU. 
4 UNU study 
 
EN 11   EN 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 producer s 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 resu lts have already been achieved: 
– Compared to the 1990s, in 2005 about 2 milli on tonnes of WEEE have been diverted 
from disposal without any pre-treatme nt, by separate collection followed by 
treatment operations 
– The RoHS Directive has resulted in reduci ng the quantities of th e banned substances 
being disposed of and potentially releas ed into the environm ent 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 f acilities (15 new facilities in the EU-15 plus 
treatment facilities serving several new Memb er 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 possibl e. 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 expe rience and knowledge to design more effective 
collection and recycling/recovery targets, str eamline the process of granting exemptions under 
the RoHS Directive and efficiently widen the sc ope 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 equi pment covered by the substance ban (possible 
inclusion of control a nd monitoring and medical equipment) , and the collection and recycling 
targets for 2008, with the aim of adapting the provi sions to scientific ev idence as well as to 
technical and economic experience in the Member States.
6 
Furthermore, a review of the Directives is  foreseen by the Comm ission's simplification 
strategy, which should c ontribute to better implementation a nd enforcement of the Directives 
at national level. 
Also based on the experience with implementati on and enforcement of the two Directives at 
national level the following issues appear to requ est particular attentio n: Clarifying the scope, 
reviewing the substance ban, streamlining proced ures, strengthening co llection and recycling 
targets (WEEE), improving enforcement, clarif ying definitions and clarifying relations 
between the two directives  and with other relevant  Community legislation.  
                                                 
5 Arcadis report (See Annex I) 
6 See Articles Articles 4(3) and 6 of the RoHS Direc tive and Articles 5(5), 7 (4) and 17 (5) of the WEEE 
Directive. 
 
EN 12   EN 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 Dir ective on the restriction of the use of certain 
hazardous substances in electrical and el ectronic equipment (RoHS) (late spring 2007); 
following the conclusion of the second cons ultation on policy opt ions (February 2008) 
drafting of the Impact Asse ssment 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 provi ded input to all important 
milestones of the review (preparation of st udy reports, stakeholder consultations); in 
particular during 2007 it was extensivel y consulted and provided comments on the 
background documents for the two stakeholder consultations on th e RoHS Directive review. It 
was also convened in May 2008 to discuss the po licy options to be presented in the impact 
assessment. 
1.2. Consultation and expertise 
• Studies 
A comprehensive study (referred to below as th e "ERA report") regardi ng the possibility of 
including medical devices monitoring and contro l instruments, as requested by Article 6 of 
RoHS, was carried out in 20067.  
 
A study8 (Ökoinstitut) examining the need and feas ibility 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 sc ientific 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 as pects 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 partic ular with regard to th e 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 ma rkets and development of cost/prices. 
                                                 
7 http://ec.europa.eu/environment/waste/pdf/era_study_final_report.pdf . 
8 http://hse-rohs.oeko.info/.  
9 http://ec.europa.eu/enterprise/environment/reports_studies/index.htm  
10 http://ec.europa.eu/environm ent/waste/pdf/weee_review.pdf  
 
EN 13   EN Furthermore, the relevant information from th e preparatory studies ca rried out under the Eco-
design framework Directive (EuP) has been considered where relevant. 
• Stakeholder consultations 
Two structured stakeholder consultations have  been launched via th e EUROPA website, one 
inviting comments on topics and for informati on 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 re gular contacts with industry  (in particular  the industry 
associations for medical devi ces, 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 cri tical stages of the above mentione d studies (for example in July 
2007 and May 2008). 
The responses to the consultati ons covered a large st akeholder and geographical spectrum and 
there were considerable variations in th e extent and quality of the contributions. 
Industry stakeholders focused on the need of streamlined and harmonised implementation (in 
particular with regard to scope and dem onstration of compliance) and speeding up the 
exemptions mechanism. NGOs called for enhanci ng the environmental and health benefits of 
the Directive. 
The preselection of topics' by the Commission se rvices was not fundament ally 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 a nd therefore the Commission services used it as 
a basis for developing th e detailed policy options. 
In the second consultation the options were presented for each topic highlighting pros and 
cons; stakeholders were invited to expre ss 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 benef its 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 fu ture orientations of RoHS in general.  
Some went as far as suggesti ng phasing out of RoHS and entrus ting the hazardous substances 
management in REACH, but the vast majority of stakeholders did no t share this view. In 
general stakeholders submitted constructive ideas for clarifying concepts and reducing 
uncertainties. 
The standards applicable to public consultations in term s of duration, transparency, 
acknowledgement of receipt and feedback have been respected. Stakeholders have been pro-
actively notified about launching of the consu ltations, given the possibility to view all 
relevant non-confidential contributions and informed about the outcome through publication 
of a summary of the comments. 
 
EN 14   EN Contributions and summary of stak eholder comments are available at 
http://ec.europa.eu/environmen t/waste/weee/events_rohs2_en.htm . 
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, enfor cement activities started in 2007) as well as the 
absence of formalized compliance/reporting mech anisms. Another important aspect is that 
some information on cost of compliance activi ties (for example technical modifications of 
products, materials' use, internal organisati on) are considered by some companies as too 
commercially sensitive to be shared in a stakeholder consultati on or a study of the 
Commission services. 
Comments from the Impact Assessment Board 
A draft of this Impact Assessment was ex amined by the Impact Assessment Board and 
discussed during its meeting of 2 July 2008, af ter which comments were formulated by the 
Board, complementing its preliminary remarks prior to the meeting. In essence the Board 
recommended clarifications and improvement s 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 interacti on of RoHS with other major policies of the 
EU on chemicals (REACH) and environmen tal performance of products (EuP)  
• Need to support the analysis  of options and final reco mmendations with additional 
quantitative data and quantified arguments 
• Upgrading of the assessment of the administrative burden 
• More consistent presentation of the views of stakeholders, in pa rticular with regard to the 
more sensitive options, such as the recommende d 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 s cenario was outlined, information on the 
environmental benefits of including categ ories 8&9 in RoHS a nd a new annex giving 
quantitative information on cost impacts and methodological approach and assumptions were 
added; in particular this anne x addresses the estima tion of the administra tive burden from the 
current RoHS Directive and its expected re duction if the recommended options are adopted 
during the RoHS review. As appropriate, key inform ation was inserted also in the analysis of 
options and the executive summary.  
                                                 
11 Following two rounds of structur ed 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 elect rical and electronic components. 
Therefore, it will be difficult to estimate the relevance of EEE fo r the total consumption of the 
substances…" 
 
EN 15   EN The relationship with REACH and RoHS was furt her explained, including in the analysis of 
options, as well as some further elements from  the broader context (E CJ ruling on DecaBDE), 
necessary for better understandi ng of options and recommendati ons. Stakeholders' views were 
more amply presented in the introduc tion and some individual key options. 
2. PROBLEM DEFINITION  
2.1. Problems requiring action 
EEE contains numerous substances that can ha rm human health and the environment (Annex 
I) if the equipment is designed inappropriately or treated ina ppropriately 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 humans
12. Sound management of waste from 
EEE (WEEE) reduces release of HS into the e nvironment and Community legislation to this 
effect is in place. However, even in the EU le ss 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 envi ronmental 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 th ese 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 Direct ive therefore is a bu ilding 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 th an two years. During this time it has already 
reduced the use of HS in EEE a nd thereby the risk of exposure significantly (Annex I). Within 
this time neither the drivers mentioned above no r the rationale for reduc ing 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 unintenti onally high efforts or  costs for market 
actors and administrations in complying with th e Directive. Most recently, the Electra report
14 
                                                 
12 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 
13 Arcadis report, p.69 
14 "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 transpos itions are quite divergent in different member 
states. Some member states, for in stance, reject the New Approach un derstanding in the context of the 
putting products on the community market. Other countries, Austria, Italy included the «Homogeneous 
 
EN 16   EN recommends harmonisation of the RoHS scope and of its applicati on, 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 environmen tal 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 a bout 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 exam ple, what means "lead- or cadmium-
free"?) in different ways as some Me mber States have specified differing 
methodologies. This creates additional admini strative costs for operators trading in 
more than one Member State. Other Me mber 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 pa rts"; although there is no information on the 
quantities of non-compliant parts which ar e placed in the market by manufacturers 
and whether they are used exclusively fo r 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" wh ich, 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 an d Italy included MCVs (maximum concentration 
values) into transposition laws. Proposals for im provement: 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…" 
15 See ARCADIS study, part 5.2.2.3, p.103-104 and industry contributions to the stakeholder 
consultations: http://ec.europa.eu/envi ronment/waste/weee/events_rohs2_en.htm 
16 See ARCADIS study, p.133 
 
EN 17   EN First market surveillance activit ies 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 actio n that Member States do take would improve 
and synergies created by bette r communication through the internal market. Unequal 
treatment of EEE on the internal market
17 and resulting additional, unnecessary administrative 
costs18 as Member States have taken divergen t approaches with respect to national 
enforcement. 
The recently adopted Regulation concerning market surveillance19 ("Marketing of Products 
Package") will apply also to RoHS, however th is is not likely to be clear to economic 
operators, and may not be imme diately clear to many enforcem ent authorities, so some 
confusion and difference in implementation acr oss the Member States is predicted to 
continue.  
• Problems related to perceived inconsistenc y with other Community legislation or 
technical/ scient ific progress. 
Since the development of the RoHS Direct ive 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 conseq uences of these rela tions are not always 
sufficiently clear for operators. There are perc eptions of inconsistencies between RoHS and 
other pieces of EU legislation, leading to unne cessary 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 Europ ean 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 c ourse 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 widene d, 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 Martin et al. In "The EU restriction of Hazar dous substances Directive: Problems arising from 
Implementation Differences between Member States  and Proposed Solutions", (RECIEL 16(2) 2007, 
Blackwell Publishing Ltd) present the results of tele phone interviews conducted with 21 Member State 
RoHS enforcement officials and come across, inter alia, diffe rent 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 to wards market surveillance. 
18 "Collecting and reviewing information" accounted for 49% of administrative burden, according to 
ARCADIS study, part 5.2.2.3, p.104 
19 Decision 768/2008/EC and Regulation (EC) 765/2008, OJEU L218, 13.08.2008 
 
EN 18   EN present situation. It is therefor e necessary to exempt such applications from the legal ban. 
However, the RoHS process for granting exem ptions 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 allo wed to put equipment on the ma rket and administrators face 
legal uncertainty when trying to assess the co mpliance of such equipment. Especially for 
products with short innovation cycles this can lead to signifi cant economic losses. 
2.2. Underlying drivers of the problems 
• Implementation-related problems 
Implementation-related problems (notably diffi culties in deciding wh ether 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 l ack 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 organisa tion given to product compliance.  Disparities, in turn, are 
partly due to differing perceptions by Member St ates of what constitute effective mechanisms 
for reporting, assessing product compliance and carrying out market surveillance.  
• Coherence/consistency-related problems 
Problems arising from mis-percep tions of the inter-relation betw een 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 legislati on while trying to minimize additional burden and 
efforts without reference to authoritative and use r-friendly explanations or cross-references.  
Restrictions in scope are rela ted to incomplete knowledge at the time the RoHS Directive was 
created, whilst technical and sc ientific progress has now provided more information. This has 
caused the exclusion of other produ ct categories that could have enhanced the benefits of the 
Directive. 
Inconclusive and incomplete scientific and soci o-economic information is also the main driver 
behind problems related to adapti ng 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-representati on of socio-economic considerations in the 
process can cause market disadvantages for produ cers that are refused exemptions as a result 
of insufficient cost-benefit assessments. 
 
EN 19   EN 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 le gal 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 trea tment 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 producti on and WEEE recycling and treatment 
facilities (in the EU and part icularly 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 he alth from exposure to Hazardous Substances in EEE and 
already regulated by RoHS 
There are various factors which will influenc e 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 cycl es, 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 reducti on of exposure for the next 5 to 10 years at 
least. Indeed, one needs to ta ke into account the life time of EEE which is quite diverse and 
can be even longer that 20 years for some special ised 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 gradua lly, 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 expo sure will depend on 
 
EN 20   EN many factors including the efficient checking of illegal WEEE shipments, the improvement of 
facilities and strengthening of e nvironmental legislation and enfo rcement 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 activit ies; 10 MS have reporte d inspection campaigns; 
these campaigns covered various numbers of EEE products and companies (below 100), 
involved various degrees of requests for comp liance documentation&tes ting and resulted in 
warnings or even (very few) w ithdrawals of products; the results  of most of these campaigns 
have not been published or are not even availabl e.. 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 nati onal level with the appliaction of  the recently adopted related 
Regulation (in the context of the "Marketing of products pack age"). Obviously the actual 
improvement will depend on the extent of the market surveillance ac tivities that national 
authorities will deploy and the efforts that  manufacturers will undertake to improve and 
demonstrate compliance; but no drivers for a ch ange in these trends are currently observed. 
Looking at the problem caused in particular by medical devices and co ntrol and monitoring 
instruments, although it is claimed that many of these products due to th eir specialized use are 
not disposed of in an uncontrolled way at their end of life, studies
20 show that only 50% 
(medical devices) to 65% (control and monitori ng 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 toxi city potential, freshwater aquatic , freshwater sedimental and 
terrestrial ecotoxicity potentials.  
It seems highly unlikely that the content of the substances in th ese products will be affected in 
the short to medium term (e.g up to 2016) by eith er 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 microsc opes) do not meet the EuP threshold of 200 
000 units sold per year; such complex and specia lised products due to their size can also be 
assumed to represent a higher % in the overall WEEE tonnage th an their sold numbers would 
make believe21; the fact that they normally do not  have energy consumption as their 
overriding environmental impact brings them fu rther down the priority list of EuP at this 
stage.   
                                                 
20 UNU study, final report August 2007 carried out to support the WEEE review 
21 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) 
 
EN 21   EN These categories of products account for appr oximately 1% of all EEE sold annually in EU 
and for 0,2 – 0,3% of WEEE by weight. The quanti ties 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-BDE
22.  
Industry claims that lead-free soldering is an yway 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 solder s 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%. Ho wever, 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 st andard) 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 be st use of a well functio ning internal market. 
Uncertainty among manufacturer s about legal requirements for demonstrating RoHS-
compliance and about enforcement methodologies in the 27 Member States will persist, 
maintaining or increasing administra tive burden and legal uncertainty. 
The Impact Assessment of the Marketing of Products Package
24 indicates that product 
conformity assessment related costs can be on th e average up to 1-2% of unit production cost 
(less for large scale production) for complying with related requiremen ts in the area of 
harmonised EU legislation affecting EEE, e.g. on safety.  
The RoHS Directive currently does not forese e explicit reporting ob ligations 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 aut horities for compliance de monstration 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 provi sions 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 authorit ies; the result could be costs higher than 1-
2% which would be the maximum expected rate if harmonised co nformity assessment 
requirements are introduced in  RoHS.confusion and difference in implementation across the 
                                                
 
22 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 
23 EDMA contribution to the stakeholder consultation 
24 P.58 
 
EN 22   EN 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 ma rket 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 ava ilability of field data for substitutes which 
would promote their reliability and availabili ty; 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 pr ocedure, 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 pl ace to tackle problems arising 
with both products and waste.  Moreover, Council and the Eu ropean 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 adap tation 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 leve l less burdensome, easier to apply and thereby 
more effective. The Commission is comm itted to reduce unnecess ary burdens while 
preserving the level of environmental protection. 
3. OBJECTIVES  
3.1. Objectives  
The general objective  is to achieve the objectives of th e RoHS Directive more effectively 
and efficiently, thus optimizing benefits for the so ciety as a whole in return for the legislative, 
administrative and economic efforts required, th ereby to contribute to  a better regulatory 
environment that is simple, understandable, effective and enforceable, thus advancing sustainable development and environmental prot ection 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 requi rements 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 23   EN 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) 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";  
(b) Definitions that are easier to interpre t (for example in line with Community 
product legislation). 
(c) Clarity for users on the relati onship to other legislation 
(2) Improved enforcement of the Directive at national level: 
(a) Minimized number of non-compliant pr oducts by improved effectiveness of 
enforcement;  
(b) Increased legal certainty for opera tors across the internal market. 
(3) A Directive that is adapted to technical and scientific progress : 
(a) Faster mechanism for granting exemptions; 
(b) A product scope adapted to techni cal and scientif ic progress; 
(c) Restrictions on use of HS in EEE where justified by scientif ic 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 adop tion. These include notably the Lisbon and 
Sustainable Development Strategi es (including simplification/be tter regulation), the “Energy 
and Climate” Package, the 6th Environm ent Action Programme and the Community 
Strategies on natural resources and waste mana gement, 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 RE ACH and the EuP Directive are particularly 
relevant. 
REACH focuses on the chemical substances wh ile RoHS is product legislation dealing only 
with hazardous substances in EEE. The complementar ity consists in that, if  a substance that is 
subject to authorisation under REACH is rest ricted 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 en sures that any conflic t between REACH and 
RoHS is avoided. 
 
EN 24   EN EuP addresses toxicity as one among all signif icant environmental aspects of a product and 
during the first phase of implementation focuse s 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 (t echnical/economic) of th eir 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 Di rective is complementar y and coherent in its 
substance with other relevant Community legi slation. Nevertheless, some scope for better 
clarifying these relations and modernizing te rminology in line with newer policy exists. 
Options for doing this are also discussed in this impact assessment. 
4. D
ESCRIPTION OF POLICY OPTIONS  
Options are grouped in relation to  the objectives descri bed in section 3. To focus the analysis 
on the most important possibilitie s, other options whic h the Commission had considered at an 
earlier stage but found unsuita ble 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 fo r its scope; this option c onsists 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; th e WEEE Directive would re fer 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 pa rts"; 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 25   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 Ro HS as well, it is not 
written in the RoHS legal text; this option cons ists in explicitly excluding military equipment 
and equipment which is part of another equipment in the definition of the RoHS scope. Specifically to: 
(d) Insert in RoHS clause similar to W EEE Art 2.1 (excluding equipment which is 
part of another type of equipment th at does not fall within the scope); 
(e) 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 recen tly adopted "Marketing of Products Package"; 
definitions for medical devices and industria l control and monitoring equipment; definition 
for "homogeneous material" from the Guidance Document of the Commission services
25. 
4.2. Options to improve enforcement 
The options 4.2.2–4.2.3 are not mutua lly exclusive but complement ary 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-co mpliant products from the market 
This option consists in inserting provision s from the "Marketing of Products Package" 
establishing obligations for Member States to  carry out market surveillance activities with 
regard to products' compliance w ith RoHS, to exchange inform ation 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 in ternal design control for compliance of their 
products with RoHS and affix the CE marking befo re placing them in the market and give the 
possibility to use EU harmonised standards 
                                                 
25 http://ec.europa.eu/environmen t/waste/weee/pdf /faq_weee.pdf. 
 
EN 26   EN (b) Include conformity assessment proce dures: use of standards, external 
verification and CE marking 
Insert the obligation for producers to have veri fication 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 exempti ons) 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 manu facturers requesting an exempti on to submit their analysis for 
possibilities of substitution of the banned substa nce 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 standa rd 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 s hould 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 y ears, unless a renewed request is accepted. 
4.3.2.  Adapt product coverage to tech nical 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 Ro HS and the use of voluntary commitments or 
standards and existing EU legislation (Ecodesi gn Framework Directive, REACH) to try to 
achieve the objectives. 
 
EN 27   EN 4.3.2.2.  Make no changes, not incl ude Categories 8 and 9. 
Medical devices and 'control and monitoring' in struments (Categories 8 and 9) were included 
in the WEEE Directive but excluded from th e RoHS Directive because a longer adaptation 
period was needed for these pr oducts the high reliability of some of which is critical. 
Council and Parliament (in Article 6 of the Di rective) 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 a nd 9 with specific exemptions: 
(a) from 2012 
(b) from 2014  
(c) delayed inclusion of cat.9 industrial equipment (2015)  
(d) delayed inclusion of certain medi cal devices (IVD : 2016, AIMD : 2020) 
This option consists in incl uding both categories  in the scope of RoHS and granting 
exemptions for certain applications of the ba nned substances. The sub-options differ in the 
deadlines and the treatment of some sub-categories of products. 
a) Inclusion of products falling within categor ies 8 and 9 from 2012. 2012 is a realistic date 
for the legislative proposal to pass through the legislative proc ess and be implemented by MS. 
b) same as a) but with longe r period for adaptation granted. 
c) Can be combined with any of a) or b); independent from 3d): gr anting longer adaptation 
period to industrial monitoring and control instruments by submitting them to RoHS in 2015. 
d) deferred enforcement date for in vitr o 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 cont ain other HS. Article 6 of 
RoHS asks the Commission to adapt the list of regulated substances on th e basis of scientific 
facts and taking the precauti onary principle into account. 
 
EN 28   EN 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 informati on 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 rele asing DecaBDE from the ban26. 
4.3.3.3.  Add new substances for all EEE, in th e scope of RoHS but with exempted 
applications 
In line with the abovementioned requirements of Article 6 the resu lts of a study of the 
Commission services and other available informati on, this option consists in extending the list 
of substances banned by Ro HS by adding certain HS. 
5. ANALYSIS OF IMPACTS  
As mentioned before, it proved difficult to obt ain all the necessary information in order to 
comprehensively address all the impacts of the po licy options. This applies to an even greater 
extent to the social impacts. 
However, during the stakeholder consultations and the preparator y studies two broad kinds of 
impacts of social nature were identified: 
Health:  In particular related to th e 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 involve d in WEEE recycling. The recommended options for the 
inclusion of medical devices (s ection 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 th e exposure to HS. 
Employment:  Although economic operators and admi nistrations had to mobilise human 
resources for complying with RoHS, the prepar atory studies did not re veal 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 On 1 April 2008, the European Court of Justice annulled the DecaB DE 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 w ith and annulled the exemption fo r DecaBDE while maintaining its 
effects until 30 June 2008. 
27 Arcadis study, p.109: in most cas es apparently a reallocation of st aff took place but no job creation 
 
EN 29   EN 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 sectio n 2 will persist or increase because of the 
increasing variety of EEE and distribution outle ts, as well as further differentiation of 
implementation in MS. This w ould create an administrative burden probably higher than 
the one avoided by not introducing new pr ovisions for scope and definitions. 
• Informal clarification and coordination initiatives by Member States authorities and the 
Commission services are not le gally 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 therefor e 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 ma nufacturers 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 author ities have already been  discussing at length 
the "grey area" products and have developed considerable expertise
28. Making Annex IB 
binding would clarify the scope and therefor e reduce administrative burden and would be 
compatible with the legal basis of RoHS (Article 95 of the Treaty, harmonisation).  
• Environmental and health protecti on 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 inte rvals 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 30   EN • For many EEE categories both WEEE and RoHS will still apply. Manufacturers and other 
stakeholders will have to implement them join tly and there is a close link between the two 
Directives (for example the treatment requi rements of WEEE must  take into account 
RoHS); separating the scope will not reliev e 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 co sts will be eliminated if RoHS defines the 
WEEE scope (an option examin ed under the WEEE review). 
• The adaptation of the annexes by the Regulator y 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 ha ve 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 sc ope and hence include legal certainty and 
reduce economic risks, for example from diff erent Member States' interpretation: certain 
types of equipment are considered by some stakeholders as "par t/component" and not 
"final product" which, in th eir view, can be the only type of equipment falling under 
RoHS; such diverging interpretations will ceas e with the proposed cl arification. 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 produ ced 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 contri bute to spreading clearly and more equally the burden and 
cost of compliance throughout the supply chain. It would facil itate information supply and 
compliance for final product manufacturers, w ho would benefit from a reduction of the 
administrative cost. 
• The environmental benefit of the clarificati on of this scope is uncertain, though positive: 
the Commission does not have data on the numbe r of non-compliant part s 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 31   EN Costs: 
• The practical implementation co st for parts’ manufacturers s hould not be significant, given 
that, already now, all parts and components inte grated in new finished products must be 
RoHS-compliant.  
• The majority of industry stake holders 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 obligati ons 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 fo r the environment since it contributes to 
extending life time and avoiding untimely disposal of equipment. 
• It would bring legal certainty for manufactur ers with regard to servicing EEE after an 
exemption expires and security for end users th at they will not have to replace prematurely 
the EEE because of lack of spare parts. This is particularly im portant for high cost and long 
life time EEE as, for example, some medi cal 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 te rm "part" is used properly (some industry stakeholders 
consider whole EEE destined to  replace defective products u nder 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 us e of non-compliant spare parts. 
5.1.4.  Clarification on excluded equipment 
(a) Insert in RoHS clause similar to W EEE Art 2.1 (excluding equipment which is 
part of another type of equipment th at does not fall within the scope); 
(b) Insert in RoHS clause similar to W EEE Art 2.3 (excluding equipment which is 
intended for specifically military purposes). 
Benefits: 
• The Guidance document prepared by the Comm ission services in cooperation with 
Member States is known and to a large ex tent already used by Member States and 
manufacturers; transposing its interpretation in the RoHS legal text will increase legal 
 
EN 32   EN certainty about the scope and hence reduce admi nistrative burden, part icularly by reducing 
differences in interpretation betw een Member States in future. 
• Environmental and health protecti on 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 co sts since it would reflect in th e legal text what is already 
current practice. 
5.1.5.  Adding/modifying definitions 
Benefits: 
• Industry stakeholders have pointed out at vari ous occasions since the entry into force of 
RoHS that diverging interpreta tions of some concepts ("plac ing on the market") leads to 
market fragmentation ; defining them w ould remove ambiguity, enhance the free 
movement of EEE in the internal market29 lead to more harmonised interpretation and 
hence increase legal certaint y and reduce economic risks becau se 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 subs tantial economic benefits (reduction of 
administrative burden for administrations and producers30) can be achieved 
• In the case of medical devices, adopting the de finitions of other rele vant EU legislation 
would create legal certainty;  
• As a postponement of the enforcement date  is proposed for industrial control and 
monitoring instruments, clarif ication of what is “industria l” would increase clarity and 
reduce administrative burden for the impl ementation of this postponed enforcement. 
• Inserting the definition for "homogeneous ma terial" of the Guidance Document (already 
largely used by stakeholders) in the legal te xt would strengthen the legal basis for EEE 
manufacturers in demonstrating compliance a nd 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 impl ementation was based on them; this is not 
expected to be significant because many stak eholders already apply the definitions of 
relevant Guidance documents. 
                                                 
29 Martin et A1, p.225 
30 Arcadis report, Martin et Al 
 
EN 33   EN • Some stakeholders raise doubts as to the suitability of the available definition for 
"homogeneous material" for enforcing the ba n (for example for measuring content of 
hexavalent chromium; it is also claimed that small parts should be considered as "homogeneous material"); if a different defini tion 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 te chnical issue would give rise  to uncertainty and possible 
increase of administrative burden fo r authorities and manufacturers. 
5.2. Options to improve enforcement 
5.2.1.  Make no changes: not add pr ovisions aiming at be tter 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" scen ario 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 contin ued and increased administrative burden and 
problems in the free movement of EEE to the extent that not suffici ently coordinated and 
coherent national market surveilla nce activities will be deployed. 
5.2.2.  Strengthen mechanisms to remove non-co mpliant 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 woul d mobilise and coordinate efficient market 
surveillance activities. This is  considered also by producers
31 a major step to protect 
compliant companies from unfair competition of non-compliant products‘: although it is 
difficult to estimate the share of non-comp liant 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 complia nt; the loss of in dustry 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 clarifi cation of obligations, facilitati on of internal arrangements, 
sharing of resources among Member States au thorities and allowing these authorities to 
simultaneously control product compliance wi th requirements from several Community 
legal acts) and increase cohere nce and predictability for EE E economic operators (such as 
manufacturers, distributors, importers). 
                                                 
31 This is also one of the conclu sions of the Arcadis report, p.144 
32 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 34   EN • Effective market surveillance mechanisms at  national level and ha rmonised approach for 
removal of non-compliant products would grea tly enhance the environmental benefit of 
RoHS by minimising the number of non-comp liant products on the market. Current 
Member States' checks revealed that up to 44% of EEE checked were not fully compliant.  
• Structured cooperation between market surveillance authorities would reduce 
administrative costs for both the authorities (for example enhanced information sharing 
would avoid the need for rep eating investigations on a pr oduct done in another MS, in 
particular regarding expensive testing) and the manufacturers (no need to submit the same 
file in various administrations).  
• Information availability and exchange would be significantly enhanced by structured and 
harmonised market surveillance 33 
• The provisions on market surveillance are pa rt 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 wi ll facilitate understa nding 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 surv eillance authorities), 
but this would vary depending on current im plementation practices  of individual MS; 
Moreover, given that some work  in this direction has alread y been done (informal network 
exists), additional cost for au thorities 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 woul d be violation of thei r existing obligations. 
If "due diligence" is alr eady 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 procedur es: use of standards, self declaration 
and CE marking  
                                                 
33 Market surveillance in FIN yielded important information on the content of hazardous substances in 
EEE,  
34 On this point the Impact assessment carried out fo r 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 en abled by, inter alia, improved information flows  
 
EN 35   EN (b) Include conformity assessment pro cedures: use of standards, external 
verification and CE marking 
Benefits: 
• RoHS has currently no provision on how ma nufacturers 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 w ould enhance clarity for manuf acturers (for which this 
omission can be an important source of administrative burden
35) 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 manufact urers and authorities alike. 
• Harmonisation of CA procedures would be be neficial for the internal market (some 
Member States already introduce on an individu al basis CA procedures or envisage to do 
so, and if they diverge, this  might create problems in th e movement of goods) and fair 
competition (including through harmonisation of requirements on documentation for compliance and declaration of conformity).  
• A structured, uniform CA pro cedure facilitates the manufact urers’ 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 e nvironmental benefit. 
• CE marking provides already presumption of conf ormity 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 effici ent and recognisable means to demonstrate compliance 
• In option 2.3 (a) : The “Marke ting of Products” package introduces CA procedures that 
would allow manufacturers to demonstrate comp liance with RoHS and a number of other 
Directives in one single document (Declaration of Conformity).  
• Standards for identification and measurement of the restricted substan ces, for labelling and 
for communicating across the supply chain faci litate demonstration of product compliance 
and enforcement activities and can promot e 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 increa se credibility of the 
CA and the checks would prompt greater compliance action by pr oducers currently not 
aware that they are non-compliant. It would th erefore probably lead to an increase in 
substitution of the banned HS compared to se lf declaration. Otherwis e the benefits would 
be the same, as described above. 
Costs: 
                                                
 
35 Martin et Al, p. 226-227 
 
EN 36   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 mech anisms for demonstrating compliance would 
be higher for those manufactur ers 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 3
rd 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 woul d probably be similar to that  for third party assessment 
of other products
36. 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. Effo rt will be required by stakeholders and 
administrations to develop the harmonised sta ndards. If such standards take too long to 
prepare and the Directive depends on their existence, the Directive’s implementation would be delayed. Although international standa rds can promote world trade and should be 
preferred, when possible, it is only EU harmonise d 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 curre ntly under separate technical review in 
accordance with Article (5)(1)(c) of RoHS; the draft proposal fo r the review of RoHS will 
therefore include as Annex II the current a nnex of RoHS, as amended by the successive 
Commission decisions.  
In Annex III are included the specific exempti ons for the new categories of products (medical 
devices and control and monitori ng instruments), which preparator y studies have shown to be 
justified. 
The Impact Assessment examines options fo r 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 37   EN • The few stakeholders who have used the exis ting mechanism have staff who are used to 
the existing mechanism and no adaptation effo rt 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 cha nges 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 a ssociated required 
administrative effort from authorities and ma nufacturers; increased cl arity about the scope 
of RoHS for manufacturers (product designers would no longer need to  consult changing 
lists of exemptions) and facilita tion of market surveillance (p roducts within the scope must 
be "free" of the restricted substances, no exemptions to be taken into account). 
• It is estimated that manufacturers’ costs fo r 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 str eamlining 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 fe w. It has not been 
possible to demonstrate for any of the EE E categories currently covered that the 
implementation cost is disproportionate to th e environmental benefit and thus justify its 
exclusion from RoHS. This means that ex cluding all the EEE pr oduct categories which 
need exemptions so that for the ones remain ing in RoHS the whole exemption mechanism 
would be redundant, will most probably reduce substantially the environmental benefit of 
the Directive. 
• Adopting this option in rela tion to any product group woul d 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 di rect communications with industry representatives. 
 
EN 38   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 
(a) Introduce requirement for anal ysis of substitutes; 
(b) Introduce broader criteria for granting exemptions; 
(c) Introduce standard format and validity period. 
Benefits: 
• Poorly substantiated and unjus tified 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 causi ng 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 redu ce administrative burden for Member States' 
administrations, Commission services and manuf acturers, in particular those who submit 
justified and well substantiated requests, whic h will be accepted much more quickly than 
in the past. 
• Currently RoHS accepts as reasons for granti ng 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 di stortion 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 administra tive 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, scien tific or economic uncertainty as to when s ubstitution can 
actually take place, detailed substitution plan s may prove hard to draw up and a legal 
requirement to produce them would be too burde nsome, 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 alternativ es 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 s ubstitution plan. Integrating a requirement for analysing 
substitutes in RoHS should not incur any sign ificant additional cost s in the medium term, 
because economic operators will have to ge t acquainted with the REACH procedures and 
                                                 
38 http://ec.europa.eu/enterprise /reach/docs/reach/REACH_TAC_summ ary_report_fin al_19122006.pdf 
table 1, p.18 
 
EN 39   EN establish mechanisms internally and for c ooperation (e.g. on sharing of data) with each 
other for fulfilling those at a reduced cost. 
• It may prove hard to collect data to adequate ly support claims of l ack 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 author ities (who have to evaluate them in the 
Regulatory Committee). 
5.3.2.  Adapt product coverage to tech nical and scientific progress 
5.3.2.1.  Remove all products from scope  of ROHS – repeal ROHS 
Benefits: 
• Manufacturers would avoid some ongoing cost s 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 turnover
39. This would be the maximum cost 
avoided, but the costs actually avoided w ill depend on the extent to which industry 
switches back to using the HS  
• If industry makes voluntary agreements not to return to those substa nces, repealing RoHS 
might help reach the policy objectives in a mo re cost-effective way; (for example, the 
medical industry has already created an eco-des ign standard), however administrative costs 
from implementing any voluntary agreements  and reporting under th ose agreements is 
likely to be similarly, or perhaps more, bur densome for manufacturers compared to the 
ongoing administrative costs from RoHS. 
• The upfront costs incurred by industry fo r RoHS compliance (understanding and 
implementing the legislation, capital expend iture and operating costs for making the 
necessary changes in the production process) would not be saved by repeal. Although most 
manufacturers have not calcula ted the cost, industry (for pr oducts 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 co mpliance) make up 
approximately 67% of total costs, while th e 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 ongoi ng 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 co sts from RoHS implementation for national 
administrations (staff training, awareness rais ing, market surveillanc e involving purchase 
                                                
 
39 Arcadis report, p.101; the sample of companies is  small ( 30 companies) bu t category 8&9 products are 
well represented 
40 ERA report, p.30, 150 
 
EN 40   EN of analytical instruments a nd of products on the shelf for checking product compliance, 
additional staff expenses). Ireland repor ted monitoring costs of 10 000 € in 200741. 
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 redu ctions of use of HS it has led), the worst 
potential environmental impact of  this option would be the retu rn to use of HS in EEE and 
subsequent increase of environmental exposure. 
• Manufacturers might start using again th e banned substances, for cost reasons. 
Researchers42 conclude that lead-free soldering cr eates 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 substantiall y, if there is no cl ear increase in WEEE 
separate collection and st ate-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 sel ected products not covering the whole scope 
of RoHS, that thousands of tonnes of heavy metals and ha zardous flame retardants have 
been avoided from being used in EEE (see Annex I). 
• For estimating the net environmental cost (expr essed 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) significan tly but also that some uses of these substa nces could be 
restricted by REACH in the future. Yet, ne ither 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. Authorisati on under REACH captures incorporation of 
substances into articles only if this is done  inside the EU, thus  potentially reducing 
protection from imported products. Should restrict ions on whole groups of substances used 
in EEE (e.g. PBBs or PBDEs) be deemed n ecessary, they can be made more easily via 
RoHS. Given the potentially diffe rent priorities and the inevitably limited working capacity 
of the authorities involved in REACH implem entation 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 Arcadis report, p.17 
42 Explorative study into the Sustainable Use and substitution of soldering metals in Electronics, 
O.Deubzer, PhD Thesis, p. 178 – 180; the total a dditional 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 41   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 fa r reaching impacts on research to undertake 
efforts for substituting HS in new and existing a pplications 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-al one legal instrument 
regulating HS in EEE; this in cludes industry, which after long efforts is increasingly 
understanding and complying with RoHS re quirements. Merging RoHS with other 
instruments would most likely lead to ine fficiency concerning the achievement of the 
pursued aims and uncertainty, if  not confusion among stakeholders
44. 
5.3.2.2.  Make no changes, not incl ude 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 tech nically demanding; moreover, due to their 
sensitive character, some of them are already subject to customer qualification and legal 
certification requirements. Relieving them fr om a possible additional RoHS-burden would 
allow the industry to use fully  its scarce specia lized human resources for developing 
innovative products. 
Costs: 
• Discriminatory treatment: many pro-active manufacturers have already substituted the 
RoHS substances in many of their products, an ticipating the forthcomin g inclusion (Article 
6 of RoHS); some would stop substitution effo rts if it were announced that these categories 
would not be included and ma ny 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 mo re stringent requirements on the use of 
substances at national level; this can be a voided by introducing categories 8&9 in RoHS. 
5.3.2.3.  Include all of Categories 8 a nd 9 with specific exemptions: 
NB: The ERA report as well as stakeholders contri butions 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 Arcadis report p.130 
44 Arcadis report, part 5.2.1, p.97 : "…most compan ies have completed the changes required and are not 
requesting revisions…" 
45 ERA report, p.234 
 
EN 42   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 th e other research activ ities carried out on 
behalf of the Commission servi ces for supporting the review of RoHS and discu ssed 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 ma y 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 (accele rated phasing out of non-RoHS compliant 
parts) and will facilitate im plementation for the existing EEE categories. With this option, 
the environmental benefit is reaped at the ear liest possible stage sinc e manufacturers, even 
if they have alternative compliant products already from 2007, will not withdraw non-
compliant products unless ther e is legislative pressure49. NGOs favour an early inclusion of 
categories 8&9 in RoHS, considering that phasi ng out of the HS is ta king 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 envir onmental benefits (expressed as reduction of 
the HS present in cat 8&9 products) of the various optio ns, 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) (optio ns 3 and 2B of the graph 
respectively)
50. Option 2 of the graph does not fores ee 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 substitute s are available. 
                                                 
46 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 Di rective 76/769/EEC relating to restrictions on 
the marketing of certain measuring devices containing mercury 
47 ERA report, p.68, 235 
48 UNU Final report on the review of the WEEE Directive, August 2007, p.iv 
49 ERA report, p.237 
50 BIO intelligence study; this gr aph does not take into account the cancellation of the DecaBDE 
exemption, which would mean zero D ecaBDE for all options, including BAU 
 
EN 43   EN • 00.20.40.60.811.2
LEAD 
[kg]CADMIUM
[kg]MERCURY 
[kg]HEXAVALENT 
CHROMIUM [kg]PBB and PBDE 
[kg]BAU (Option 1)
Option 2
Option 2B
Option 3
Option 4
Option 5
Option 6
 
• 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 th e 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 reduc tion 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 gains
52; 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 coul d be as high as 7 – 10%  of turnover due to 
the additional test and approva l costs. In the case of modifying an existing complex 
product, as some products in ca tegories 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 (indi cative 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 ac tive implanted medical devices) 
or industrial control and monito ring instruments are included already in 2012, a potentially 
                                                 
51 BIO intelligence study; the indicators used were human toxicity potential, freshwater aquatic, 
freshwater sedimental and terrestrial ecotoxicity potentials 
52 Arcadis report, p.130 
53 The figures are from the ERA re port, p.237 and 150 respectively 
54 BIO intelligence study 
 
EN 44   EN high number of products will have to be with drawn from the market because of technical 
impossibility of substitution. In their recent subm issions specialised industry stakeholders 
support in principle the inclusi on 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 comp liance (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 me dical 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 like ly impact on users, because this would allow 
manufacturers to fit substitution with existing resources and product development cycles; if the date of inclusion is earl ier than 2012, average prices of  some medical equipment could 
rise by 5%
56 thus possibly resulting in negative eff ects 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 w ith the exemption procedure; although costs 
incurred by the exemption procedure make up onl y 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 woul d be as previously, but delayed by two years 
Costs: 
• According to estimates provided by ma nufacturers (ERA, p.149) most category 8&9 
products could be compliant already in 2012, taking into account the most complex 
products without negative economic impac t; including them in 2014 would unnecessarily 
delay the environmental effect  of the Directive. In rece nt position papers specialised 
industry stakeholders indicate 2014 as the pr eferred 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 a nd testing periods, the compliance cost per 
product and its dependence on the enforcement da te for categories 8&9 is higher. Choosing 
2014 as implementation date would present a re duced 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 profitabil ity for marketing new, 
compliant products so quickly. This is illustra ted by the expectances for degree of products' 
                                                
 
55 Direct confidential submissions to the Commission services 
56 ERA report, p.236-237 
57 ERA report, p.149 
 
EN 45   EN compliance: a group of category 9 products ma nufacturers estimates th at on the average 
<3% of products will be non- compliant if entry into fo rce 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 complex ity and need for reliab ility for industrial 
monitoring and control instruments. The entr y into force will take place with minimal 
technical and other (e.g. wit hdrawal of products, loss of jobs) complications, effects on 
quality of services, innovation potential and comp etitiveness because it is possible to bring 
by this date the majority of industrial cat egory 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" pr oducts) 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 suppor t, even within indus try. 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 th at the cost (loss of sales because of 
impossibility to comply and hence withdraw al 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 Ca tegory 9 equipment not used in households 
accounts for almost 75 % of the total
59. 
(d) Delayed inclusion of certain me dical devices (IVD: 2016, AIMD: 2020) 
Benefits: 
• Until the proposed deferred enforcement date  of 2016 (2020) manuf acturers will have 
sufficient time to bring these product cate gories 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 respect ively, out of the 66 000 
tonnes used in category 8 equipment60. 
                                                 
58 Direct submissions of industry to the Commission services 
59 UNU Final report on the review of the WEEE Directive, August 2007, information from Spain and 
Hungary, % of weight 
60 ERA report, p.66 
 
EN 46   EN • As for the previous option, proposing an earlier enforcement date for this type of 
equipment could lead to a to o high % of withdrawal of products from the EU market, 
because manufacturers would not have the ne cessary time for redesigning and testing 
products. Forcing a too early enforcement date  would increase the overall compliance cost 
also because untimely withdrawal of products an d this would lead to increases in cost for 
the health services (for exam ple “cost per test” for IVD). 
Costs: 
• The environmental benefit of the Directive would be delayed, alt hough the HS quantities 
involved (in particular for AIMD) are low.  
• Some IVD products could be compliant much ear lier without additional cost or health 
risks; given that a more deta iled differentiation has not been  possible on the basis of the 
available information, the propos ed postponed enforcement date  benefits also products 
which do not need it. 
• Specialized industry stakeholders agree to 201 6 as an appropriate date for including IVD 
but consider that AIMD, due to their cri tical character should be excluded for the 
foreseeable future from RoHS, 2020 is sugge sted as the earliest possible date for the 
review of such an exclusion.  
• Such a differentiated approach might give th e wrong signal to industry and not provide the 
necessary motivation for substituting HS; if su ch substitution efforts are not undertaken in 
time, adaptation will be more difficult later, gi ven the possibility of RoHS-like legislation 
spreading around the world and the decreasing availability of non-compliant parts (how 
long can AIMD manufacturers re ly on the availability of co mponents with lead-solders?). 
5.3.3.  Substances covered [article 6 of RoHS] 
Besides the already regulated substances under RoHS, EEE cont ain other HS. Article 6 of 
RoHS asks the Commission to adapt the list of regulated substances on th e basis of scientific 
facts and taking the precauti onary 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 th eir products with voluntary inst ruments (such as standards, 
lists of substances of concern) stimulate d by market demand for more environmentally 
friendly products; this would le ad to an economic benefit beca use 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 ha ndled by RoHS, more information will become 
available in the forthcoming years due to th e notification and regist ration requirements of 
REACH; this will facilitate decision making on appropriate risk management measures, 
including restrictions under REACH for th e HS satisfying the REACH criteria For 
industry, wider information av ailability throughout the suppl y chain will reduce cost for 
 
EN 47   EN implementing voluntary initiatives or regulator y 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, al ready 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 fo r a possible later substitution. 
• Removing DecaBDE from the ban would give mo re time to assess the relevance and 
concrete achievements of an ongoing industr y initiative for checki ng DecaBDE emissions 
as regards EEE. It would give more weight to  voluntary initiatives for phasing out the use 
of DecaBDE. 
• DecaBDE manufacturers claim th at the ECJ ruling only referred to procedural aspects and 
does not put in doubt the scientific and techni cal basis for exempting DecaBDE; in order to 
overcome the procedural hurdle, DecaBDE shoul d 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 ambi ent 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 ma nufacturers (including  large electronic 
manufacturers) have already replaced DecaB DE in many or all of their products by 
substitutes. At least some of the substi tutes may have minimal potential adverse 
environmental and human health effects
61. Repealing a substituti on obligation which is 
apparently economically feasible and technical ly possible by safer s ubstitutes would create 
                                                 
61 ECB study, January 2007, on the assessment of  Deca-BDE substitutes by the Commission 
 
EN 48   EN legal uncertainty and would discourage economic operators  from further voluntary 
substitution efforts; 
• In view of the recent ruling of the ECJ a nnulling the Commission Decision which allowed 
further use of DecaBDE, proposing to re move DecaBDE from the list of banned 
substances would create c onfusion 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 inte ntion to ban DecaBDE in other applications; 
the environmental protection agency of anot her Member State has clearly indicated its 
intention to implement immediately the ECJ ruling62 
5.3.3.3.  Add new substances for all EEE, in th e scope of RoHS but with exempted 
applications 
Benefits: 
• Preparatory studies have indeed revealed th e presence of other HS which potentially may 
need to be managed properly. Possible envi ronmental 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 0 00), while some of 
these HS are not chemically bound additive s which may leak to the environment during 
use63. 
• Environmental and health benefits from addr essing 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 subs tances 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 restri ctions or other measur es at national or EU 
level (e.g. TBBPA, phthalates ). Restricting them under RoHS would ensure equal 
treatment in the internal market. The ban c ould be implemented with the necessary room 
for unavoidable uses via the exemption mechan ism 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 inclus ion 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 cas e for the possible substitutes of TBBPA and 
HBCDD and, to a certain extent , of phthalates. The potentia l environmental cost from 
substitution is therefore uncertain. For some of the investigated substances the small quantities contained in EEE w ould result in disproportiona tely high burden for business 
and consumers. 
                                                
 
62 http://www.umweltbundesamt.de/uba -info-presse/2008/pd08-050.htm 
63 Ökoinstitut report 
 
EN 49   EN • Too little information is avai lable about cost: even in cases  where the substitutes or the 
necessary design changes (for example use inst ead of PVC other polymers which need less 
or no plasticizers such as phthalates) are avai lable and safe, these can be more expensive 
and there is a risk that imposing restrict ions through RoHS would create, for certain 
categories of EEE, economic cost for manuf acturers and increase considerably product 
price to the end user. The overwhelming major ity of industry stakehol ders is against the 
idea of adding new substances under RoHS a nd 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 ri sks and financial consequences from the 
generalized use of substitutes.  
• Four out of the five HS identified for furthe r analysis for possible inclusion in RoHS at a 
later stage have already been identified as  possible candidates fo r characterisation as 
substances of very high concern under REACH; imposing at this stag e a restriction through 
RoHS would create confusion among stakeholders 
 
EN 50   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 s ection 5. It also makes recomme ndations for selecting options 
Option  
(numbers refer to section 4) Overall Impact 
(based on analysis in section 5) Recommended 
Selection 
4.1.1. Make no changes to scope and definitions Existing problems for business and 
authorities will continue or even increase. 
 Reject 
4.1.2. Create an independent 
scope for RoHS Reduction of admini strative burden. 
Harmonised scope improves implementation of Directive.  
 Accept 
4.1.3. Clarification of Spare 
Parts  
a) Explicit inclusion of spare 
parts 
b) "Repair as produced 
principle" 
 a) Explicit inclusion of spare parts 
improves clarity. Distributes responsibility for compliance more evenly  
b) Allows extended life-time of EE 
products due to availa bility of suitable 
spare parts 
 Accept a) and 
b)  
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) 
 a) & b) Benefits fo r Member States and 
manufactures due to improved legal certainty  
  Accept  
 
EN 51   EN 4.1.5. Adding modifying 
definitions  
 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 s upported by stakeholde rs. Most industry 
stakeholders opposed the introduction of a defin ition of spare parts and possible associated 
administrative burden. The recommended option c onsists 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 "homoge neous 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 wh ich 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 s ection 5. It also makes recomme ndations for selecting options 
Option  
(numbers refer to section 4)  Overall Impact 
(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 c ontinue. Continued 
administrative burden for both Member States and business.  
 Reject 
4.2.2. Strengthen mechanisms to 
remove non-compliant products from the market 
 Reduction of non compliant products 
on market, resulting in reduced environmental hazards. Increased synergies with other EU product legislation, resulting in reduced administrative burden for Member States authorities and manufacturers. Promotes fair competition. Accept 
 
EN 52   EN 4.2.3. Harmonize methods for 
demonstrating compliance 
a) Include conformity 
assessment procedures: use of standards, self declaration and CE marking 
b) Include conformity 
assessment procedures: use of standards, external verification and CE marking  
 a) increased legal certainty and reduced 
administrative costs for Member States and manufactures; st andardisation can 
facilitate demonstrat ion of conformity 
and enforcement 
b) leads to dispropor tionate costs, in 
particular for SMEs, and is not justified by the risk 
 Accept a)  
Reject b) 
Promotion of harmonised implementation and enfo rcement of the Directive are major goals of 
the RoHS review. It is also an important co ncern of stakeholders, in particular economic 
operators. The Commission services estimate that such harmonisation will be promoted if RoHS includes provisions for market surv eillance, EEE conformity assessment by 
manufacturers and for presumption of confor mity of products manufactured in accordance 
with EU harmonised standards. 
Such provisions will also contribute to the ach ievement of the environmental objectives, 
reduce risks for distortion of competition among ma nufacturers 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 administ rations and businesses. 
Summary: Options 4.2.2 and 4.2.3 a) are recommended , for introducing all 
necessary provisions on the ba sis of the "Marketing of pr oducts 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 pro duct on the basis of harmonised standards 
and CE marking 
 
 
EN 53   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 s ection 5. It also makes recomme ndations for selecting options 
Option  
(numbers refer to section 4)  Overall Impact 
(based on analysis in section 5)  Recommended 
Selection 
4.3.1.1. Make no changes to the exemption mechanism Problems with length and administrative 
costs of exemption procedure continued Reject 
4.3.1.2. Remove the 
exemption mechanism from the Directive. Could hinder adaptation to scientific and 
technical progress. Reduced environmental benefit.  
 Reject 
4.3.1.3. Maintain the 
exemptions procedure with changes in the criteria for granting and withdrawing exemptions and in the 
procedure for granting 
exemptions 
(a) introduce requirement for 
analysis of substitutes  
(b) introduce broa der criteria 
for granting exemptions 
(c) introduce standard format 
and validity period 
 a) & b) Faster and more transparent 
procedure for granting exemptions. Encourages substitution efforts. 
b) avoids negative effects such as price 
increases, or withdrawal of certain products 
from the market  
c) Faster exemption procedure and 
increased legal certainty Accept a), b) 
and c)  
The Commission services estimate that abolis hing 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 disadvanta ge 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 54   EN While the standardisatio n of the format enjoyed a unanim ous support, industry stakeholders 
were against the substitution plan because it would increase the administrative burden while 
those mostly concerned with enhancing the e nvironmental 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 s ubstitution 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 reliab le and available may have ne gative environmental, economic 
and social impacts. 
The general time limitation for exemptions increas es legal certainty and has been explicitly 
supported by many Member States during in formal meetings and in the Regulatory 
Committee. 
Option 4.3.1.3 is recommended : 
– Applicants submit an analysis of subs titutes together with their request for 
exempting an application of the banned substance 
– If availability or reliability of substi tutes is not ensured, an exemption should 
be granted 
– A standard format for requesting an ex emption should be established (by the 
regulatory Committee) 
– Granted exemptions have a maximum va lidity period of 4 years but can be 
renewed 
 
6.3.2.  Adapt product coverage to tech nical 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 s ection 5. It also makes recomme ndations for selecting options 
Option  
(numbers refer to section 4)  Overall Impact 
(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 55   EN  
4.3.2.3. Include all of 
Categories 8 and 9 with specific 
exemptions:  (a) from 2012 
(b) from 2014  (c) delayed inclusion of cat.9 
industrial equipment (2015)  
(d) delayed inclusion of certain 
medical devices (IVD : 2016, AIMD : 2020) 
 a), c) & d): Envir onmental benefit from 
reduction of HS. Level playing field for manufacturers. 
b)Unnecessary delay for implementation 
of regulation and associated environmental impacts. 
c) & d) postponement for these specific 
sub-categories are justified. 
 Accept a), c) & 
d) 
Reject b) 
The Commission services estimate that 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, whic h 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 quantita tive thresholds excluding in practice many products of 
Categories 8&9 from its scope or by voluntary indus try 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 woul d 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 ec onomically unfavourable to everybody, depriving 
the EU industry from the competitive advantag e stemming from a better product and process 
control and adequate preparation for facing environmental, includ ing reduced toxicity, 
requirements worldwide. 
While the available data do not allow a fully qua ntified 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 f easible to achieve the expected  environmental benefit without 
excessive costs already in 2012, the Commission c onsiders this as the most appropriate option 
for bringing in the scope medical device s and non- industrial control and monitoring 
instruments. 
At the same time and taking into account the specificities of some  of Category 8 and 9 
products
64 (safety critical, long lifecy cles, long product development not least because of 
diverse and technically demanding functional ch aracteristics) as well as scientific and 
technical development with regard  to substitution of the substan ces 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 categori es so that negative social impacts (reduced 
availability of products due to forced with drawal of products impossible to be made 
                                                 
64 ERA report, p. 27 
65 ERA report, p.242 – 245,  
 
EN 56   EN compliant, limitation of access to high quality h ealth 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 cont rol and monitoring instruments from 2012 
industrial control and mon itoring 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 s ection 5. It also makes recomme ndations for selecting options 
Option  
(numbers refer to section 4)  Overall Impact 
(based on analysis in section 5)  Recommended 
Selection 
4.3.3.1. Make no changes to the list of substances 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 the list of banned substances under RoHS 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 contac ts 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 applicat ions of these HS in EEE but they are either 
insufficiently investigated as to their potent ial environmental and health impacts, or too 
expensive to apply in all EEE c overed by the RoHS scope, or both. 
 
EN 57   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 Commissi on services consider that the remaining uncertainties 
about its toxicity and degrad ation to other banned products , as well as the commercial 
availability of substitutes justify ma intaining 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 tu rnover (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 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 consider ed lengthy for products  with short innovation 
cycles; harmonising the requirements for the cont ents 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 auth orities 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 58   EN Environmental benefits are likely to be significant: several tonnes of the heavy metals 
banned under RoHS (>1400 tonnes of lead, approxi mately 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 weigh; 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  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 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.  
7. M
ONITORING 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) Reduction of the level of the HS regulat ed by RoHS in the EEE falling under its 
present scope  
(2) Reduction of the level of the HS regulated by RoHS in medical de vices, control and 
monitoring instruments. 
(3) Overall extent, effects and e fficiency of the measures taken by Member States to 
implement RoHS (for example via numb er of product checks carried out, % of 
compliant products, trends in reduci ng number of non-compliant products) 
(4) 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 enforcemen t of RoHS by Member States leading 
to avoidable cost 
(b) reduction of cost for conformity assessment for economic operators, 
 
EN 59   EN (c) reduction of enforcement cost for aut horities through improved administrative 
cooperation 
(5) Stimulation of R&D efforts for substituting HS in EEE to be assessed by number of 
EU patents obtained in relationshi p to substituting HS in EEE 
(6) Extent to which the RoHS review contri butes to the reduction of environmental 
burdens and health problems worldwide,  for example through contributing to the 
promotion of less toxic and more environm entally friendly EEE, including through the 
adoption of legislation restrict ing the use of HS in EEE in other parts of the world or 
of voluntary instruments (such as lists of HS, voluntary phase ou t of non-regulated 
substances by individual companies, data bases, information and training of the supply 
chain on avoidance of HS in EEE) 
(7) Reduction on number of voluntary marks for RoHS-compliance 
(8) 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 
(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 uns uccessful 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 ma de using the core indicators mentioned above. 
The details on the frequency and means of this re porting process will be left  to the decision of 
the Committee. 
 
EN 60   EN ANNEX I  
The environmental benefits of RoHS  
The reduction of quantities of  the HS banned by RoHS cont ained in EEE are used as a 
straightforward and easily understandable indicato r 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) There is little information about the HS quan tities 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. 
(2) Even today there are uncertainties about th e quantities of the ba nned substances in 
EEE: manufacturers point out that it is ve ry difficult to know exactly the product 
composition in particular when it incorpor ates thousands of components from a long 
supply chain stretching around the world. 
(3) There are uncertainties about the quanti ties of EEE placed in the EU market, a 
necessary piece of information if one is to calculate the overall HS quantities.  
(4) 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 f actors as well, such as technology changes or 
consumer preferences, or indeed other EU legal acts. 
The Arcadis study ("Study on RoHS and WEEE  Directives", No30C E-0095296/00-09, March 
2008) carried out for the Commission services (D irectorate General Enterprise and Industry) 
in preparation of the RoHS review calculate d (approximations) the qua ntities of the banned 
substances avoided being present in EEE due  to RoHS : 130605 tonnes of lead, 6251 tonnes 
of cadmium, 760 tonnes of hexavalent chromi um, 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; ta king this into account, it is estimated that the 
minimum amounts of lead in TVs avoided thanks to Ro HS are in the order of 67 000 tons per 
year 
On the above basis, and taking into account th e separate collection rates from the UNU study 
supporting the WEEE review, they also calculate d the quantities of th e banned substances 
avoided being disposed of a nd potentially released into the environment: 89800 tonnes of 
 
EN 61   EN lead, 4300 tonnes of cadmium, 537 tonnes of hexavalent chromi um, 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, Copi ers, Cell phones, TV sets, Watch/clocks, 
Fluorescent (double end) lamps, lawn mowers + gardening equipment.  
• Video games and handheld video games, Di spenser for hot and cold beverages. 
• Minimum benefit scenario i.e. minimum concen tration 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-BD E; 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, beca use there was often no detailed information. Only for PCs and TV 
sets the technology change from a cathode ray t ube before RoHS to a flat screen after 
RoHS was included. 
• Reduction in Deca-BDE presence and emission s is put to zero, based on the assumption 
that its use is allowed but from 30.06.2008 this w ill no longer be the ca se. It is estimated 
that approximately 22 000 tonnes of Deca-BDE ar e used yearly in the selected products. 
The overall environmental effects of lead substitu tion 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-fr ee 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 conclusi on 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 s upply chain affecting also EEE outside the 
RoHS scope (knock on effect). 
– greater awareness about product composition an d toxicity leading to better control of 
HS, including those not  regulated by RoHS. 
– similar legislation worldwide and hence incr ease 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 stemmi ng from the use of these substances in 
production plants. 
 
EN 62   EN – reduction of environmental and health imp acts 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. 
 
EN 63   EN 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 furthe r reduce these risks. 
The contractor carried out an extensive consul tation (overall duration th ree 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 contra ctor applied the following criteria to be used 
for the selection of HS to be further investigated:  
– Substances meting the criteria for classifi cation as dangerous according to Directive 
67/548. 
– Substances meeting the criteria for classifi cation 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 st akeholder consultations , the contractor (Öko-
Institut) established the following list of (groups of) substances , for further assessment with 
regard to possible future inclus ion in the RoHS substance ban: 
Tetrabromo bisphenol A (TBBP-A) Hexabromocyclododecane (HBCDD) Bis (2-ethylhexyl) ph thalate (DEHP)  
Butylbenzylphthalate (BBP) Dibutylphthalate (DBP) Medium-chained chlorinated paraffi ns (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 ne ed for additional risk management measures 
under the RoHS Directive for th ese 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: 
 
EN 64   EN Stakeholders contested the relevance of cer tain 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 us ed as a basis for restrictions  under the RoHS Directive. 
Concerning the substitutes -- althoug h some information is available and it is settled that they 
do not present some of the hazards (such as, pe rsistence, bioaccumulation or toxicity for the 
halogen-free flame retardants) of the hazardous substances curre ntly in use --  stakeholders 
were of the opinion that the scientific informat ion would not be suffici ent to establish with 
certainty that substitutes would be safer fo r environment and health than the candidate 
hazardous substances of the list above. 
Some stakeholders pointed out th at 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 phtha lates as plasticizers) seem to exist but 
stakeholders stated that they would not be  fit for all EEE or woul d 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 af ter the workshop, the study concludes that further 
investigation of technical su itability, (eco-) toxicological and environmental endpoints of 
substitutes is necessary; limited information exis ts 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 activi ties). The available information has not been 
specific enough to quantify the impact s 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, ther efore it is not 
proposed to include any new hazardous  substance in the scope of RoHS. 
 
EN 65   EN ANNEX III  
Options discarded at an early stage  
During the stakeholder consultatio ns 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 (includi ng for example the "large scale 
industrial tools") have not been retained. Elabor ating 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 Ro HS. It would be preferable not to undermine the 
efforts made to date for clarif ying the status of ‘grey area ’ products but rather encourage 
efforts by stakeholders, in particular enforcemen t 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 el ectricity generating equipment as a new product category in the scope of 
RoHS. 
Options to improve enforcement 
New marking has been almost unanimously re jected 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 la belling under the W EEE 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 th e 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 a ny, since sufficient pr ovisions 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 in tegrating this consulta tion in the technical 
work leading to positive or negative reco mmendations 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, becau se 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, 
 
EN 66   EN requests for applications which exist long enough for substitutes to be in place) and would 
leave room for innovation by allowing use of th e HS in new applications and technologies 
whilst not considerably damaging the overall  environmental benefit of the Directive. 
However, stakeholders in their vast majority ar e of the opinion that it would be too difficult to 
define which product or technology/applicat ion is "new" or "i nnovative". The Commission 
considers that the risk of confusion and uncer tainty 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 st akeholders (NGOs and MS). Realizing it, 
would enhance the environmental effect of the Directive in th e medium term and remove any 
uncertainty as to which equipment falls unde r the scope. However, the creation of the 
necessary negative list with exempted equipmen t (military equipment, aerospace applications, 
transport equipment, large stationary equipmen t) might lead to prolonged discussions; most 
importantly, the investigation of the full impact s of such an option cannot take place within 
the time schedule of the present re view. Other options for clarific ation of the scope (related to 
fixed installations and large scale industrial tool s) were mooted but, given the almost 
diametrically opposed views of st akeholders 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 restri ctions 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 re lease of substances 
during the end of life phase). Stak eholders considered them at mo st as part of the solution; 
labelling is almost unanimously rejected, si nce it is deemed likel y 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 ar e needed) because the availability of substitutes 
would not be necessarily ensured. 
 
EN 67   EN ANNEX IV  
Relations of the WEEE and RoHS Directiv es 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 w ith relevant Community strategies, including 
the Lisbon Strategy, the Sustaina ble Development Strategy, the Energy and Climate Package, 
the 6th Environmental Action Programme and its mi d-term review, Integrated Product Policy, 
the Thematic Strategies on the sustainable us e of natural resources and on waste prevention 
and recycling, the 'Marketing of Products' pack age and the Commission's recent lead market 
initiative. 
The review of the Directiv es 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 reduci ng CO2 emissions through energy savings from 
recycled materials and thus contribute to European climate reduction targets  agreed in 
Kyoto67. 
The substance ban, design requirements a nd waste management approach of the 
RoHS and WEEE Directives contribute to the objective of Them atic 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 exem ptions from the substance ban where 
“substitution is technically or scientifically impracticable or where the negative environmental health and/or consumer safety impacts cau sed by substation are likely 
to outweigh the environment, health and/or consumer safety benefits thereof”
69 and 
by requiring regular reviews of the substa nce bans in the li ght of scientific 
evidence70. The WEEE Directive resp onds to this by reducing the environmental and 
health impacts per unit of material used w ithout restricting the use itself or limiting 
quantities. 
                                                 
66 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 a nd thereby more effective in achieving its goals. 
Following on these principles, a re gulatory action should no t 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. 
67 Prognos study, May 2008, http://www.progn os.com/Singleview.306+M5c828d79ff6.0.html. 
68 http://europa.eu.int/comm/environment/natres/index.htm  
69 RoHS Article 5 
70 RoHS Article6? 
 
EN 68   EN The WEEE and RoHS Directives also contri bute to the objectives  of the Thematic 
Strategy on Waste Prevention and Recycling71 which calls for less waste being 
generated in terms of toxicity (“quali tative waste prevention”) and weight 
(“quantitative prevention”), a nd for an optimization of r ecycling in view of overall 
environmental and health benefits. The substance ban of the RoHS Directive 
responds in particular to the call for “qua litative prevention”. The WEEE Directive 
responds to the aim of optimized re-use, re cycling, and other rec overy at a high level 
of environmental and health protection, gi ving planning security to economic actors 
through binding collection targets and harm onized standards for waste treatment. 
In line with the Integrated Product Policy  approach72, the RoHS Directive introduces life-
cycle considerations as an essentia l 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 electroni c 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, wa ter. Moreover, the RoHS Directive explicitly 
refers to the Sixth Environment Action Program me with respect to future decisions on the 
prohibition of additional hazardous subs tances 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 fo r administrations and 
producers) and more efficient and coordi nated enforcement at Community level. 
The WEEE Directive is one of th e policy instruments mentioned in  the Lead Mark et initiative
 
78 to foster recycling markets, help more a nd better recycling yielding environmental and 
economic gains. 
Coherence with EU legislation on pr oduct design and waste management 
The provisions of the Directives are coherent w ith the requirements of other pieces of EU 
legislation on product design and wast e management as explained below. 
                                                 
71 http://europa.eu.int/comm/environment/waste/strategy.htm   
72 Reference IPP 
73 Exemptions from the substance ban are allowed wh ere “substitution is technically or scientifically 
impracticable or where the negative environmental h ealth and/or consumer safety impacts caused by 
substation are likely to outweigh the environment, health and/or consumer safety benefits thereof. 
74 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.  
75 COM(2007) 225 final. 
76 Article 4(3) of RoHS. 
77 Add reference when published. June? 
78 COM (2007)860 final 
 
EN 69   EN RoHS and REACH 
REACH79 aims to create an EU-wide system for th e management of chemicals and their safe 
use, by inter alia  requiring manufacturers and importe rs to gather information on the 
properties of chemical substances, which will allow their safe handlin g, and to register the 
information in a central database run by the European Chemicals Agency (ECHA). RoHS, on the other hand aims to contribu te to the protection of human health and the environmentally 
sound recovery and disposal of WEEE and to e liminate the disparitie s between the national 
laws of the Member States. To this end, it rest ricts the use of certain hazardous substances in 
electrical and electronic equipment put on th e 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 chem ical releases related to waste treatment, 
which forms the core of RoHS , by requiring information on a ll 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 founde d 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 Ro HS, and much wider and elaborate in scope, 
certain provisions of RoHS c ould 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 rest ricted under Article 4(3) of RoHS
80 . Using the REACH 
model, it could be clarified in the RoHS Dir ective that producers requesting exemptions under 
RoHS should be required to provide relevant in formation on the availabl e 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 propo se 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 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. 
80 While RoHS simply states that further prohibitions can be decided based on available scientific 
evidence, and the substitution of th ose 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. 
81 OJ L 191, 22.7.2005, p.29. 
 
EN 70   EN 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 improvi ng the overall environmental performance of 
selected groups of EEE, while considering ec onomic feasibility. Reducing toxicity of the 
product, e.g. by avoiding hazardous substances c ould 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 a nd efficient way, for the 
benefit of the environment and the internal market.  
To the contrary, the RoHS Directive aims primar ily at avoiding the banned substances for all 
EEE within its scope. Exemptions are only po ssible 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 pe rformance; it has direct (in the exemption 
process) and indirect (to chemicals policy, REAC H) 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 pr ejudice 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 re cycling (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 wa ste management legislation 
The WEEE and RoHS Directives apply without prejudice to Community legislation on safety 
and health requirements protectin g all actors in cont act with WEEE as well as specific 
Community waste management legisla tion, such as the Battery Directive
82 and the End-of 
Life Vehicles Directive83. 
The Commission has clarified the links between th ese pieces of legisla tion in several guidance 
documents. For example, with respect to rest rictions on the use of hazardous substances, 
batteries are covered by the provis ions of the Batteries Directive84; not by the RoHS 
Directive. Batteries are only covered by the re quirements 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 Recital 10 and Article 2 (2). It also required the 'old' Battery Directive to be revised in light of the 
WEEE Directive, recital 11. 
83 ELV reference 
84 OJ L 266, 26.9.2006, p.1 
 
EN 71   EN 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 operati ons such as recovery and disposal88 and to the general 
provisions of the Waste Shipment Regulation.89 
                                                 
85 OJ L 114, 27.4.2006, p.9 
86 OJ L 182, 16.7.1999, p.1 
87 OJ L 332, 28.12.2000, p.91 
88 See Article 3 of the WEEE Directive. 
89 See Article 6 of the WEEE Directive. 
 
EN 72   EN 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, Evaluati on, Authorisation a nd 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 
 
EN 73   EN Annex V  
Assessment of the reduction of administrative burden  
In order to evaluate the overall cost of complia nce to RoHS as a first step for calculating the 
expected reduction of admini strative burden from the recomme nded 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 th e 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 companie s responded to the 1st and 2nd round of 
questionnaires. Most of them were large compan ies and in order to pa rtly overcome the lack 
of SMEs (only 3) the results of  4 case studies from another pr oject (GreenRose) were added, 
making up a total sample of 40 companie s. The majority of respondents were EEE 
manufacturers/assemblers, two companies manuf acture 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 complic ated by the fact that the provided figures in 
many cases were incoherent. Moreover, only a limited number of co mpanies have provided 
turnover or employment figures. 
The total costs include the so-called "compl iance costs" (getting acquainted with the 
Directive’s requirements; provisi on of training and information to the different actors in the 
chain; cost of collecting, orga nising and reviewing informati on (e.g. material declarations); 
costs related to exemption procedures; costs related to organisati onal implications causing 
monetary losses) and th e "technical costs of phase-out of  RoHS substances" (capital and 
operating expenditure for the substitution, resear ch and development to find, test and employ 
substitutes to replace the restricted substances . Compliance costs (apart from the last item on 
monetary losses) corres pond 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. 
                                                 
90 Administrative costs are defined as the costs incurred by enterprises,  the voluntary sector, 
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 co sts of labelling, reporting, monitoring and 
assessment needed to provid e the information and registration. In some cases, the information has to be 
transferred to public authorities or pr ivate parties. In others, it only has to be available for inspection or 
supply on request. 
 
EN 74   EN On the basis of these data and assumptions, Ar cadis calculated the past and future one-off 
compliance costs. Compliance costs make up 67% of  total costs; the shar e 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 r each 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 re viewing 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 proce dures. 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 studi es 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 da ta found on administrative costs: 
Summary of available estimate s of administrative costs 
Source Past costs and one-off future 
administrative costs Future yearly administrative costs 
Arcadis 2008 €5,900,000/ company 
0.184% of turnover €265,500/company 
0.042% of turnover 
CEA 2008 €286,000/ company €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 a pply them to an estimate of 15,000 (figure from statistics on 
engineering industry) to 87,000 (E urostat) EU companies aff ected 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 Past costs and one-off future 
administrative costs 
million euros Future yearly administrative costs
million euros  
Arcadis 2008 89,000 – 513,000 (on the basis of cost 
/company) 
721 (on the basis of % of turnover)  4,000 – 23,000(on the basis of cost 
/company) 
165 (on the basis of % of turnover)  
CEA 2008 4,000 – 25,000 1,400 – 8,000 
 
EN 75   EN  
If we focus on future yearly costs, assu me the 87,000 figure for the total number of EU 
companies affected by RoHS is the best esti mate, 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 tur nover of EU companies affected by RoHS. 
However, due to the low overall response ra te 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 representati ve either, since basically, 
administrative costs are proportiona lly 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 feasib le 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 fo r 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 w ould thus support better regulation.  
Given the scarcity and la ck 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 manufact urers (p.150). Assuming costs in the order of 
1-4% of the turnover, BIO intelligence es timated 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 imp act, 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 ma de RoHS compliant, even if exemptions are 
granted) would be 439, 246,3 and 49,3 milli on€ 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 th ird party assessment, nor is it possible to weigh them against 
the expected increased environmen tal 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 
 
EN 76   EN of magnitude of estimated cost from conform ity assessment procedures (1-2% of overall unit 
production cost; for third party ve rification, 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 th at 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 c onformity covering many regulated aspects, facilitation of 
market surveillance). 
Finally, concerning the substitu tion 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 Costs of 
Alternatives HH & Env 
Hazard/Risk Total 
Level 1 € 875 € 1 750 € 1 750 € 4 375 
Level 2  € 2 188 € 8 750 € 10 938 € 21 875 
Level 3 € 8 750 € 35 000 € 13 125 € 56 875 
  
The possible administrative costs could be estima ted on the basis of the above table, but these 
would of course vary considerab ly 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 10
91 was not possible due to absen ce 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 dem onstration of compliance and the exemptions 
procedure. 
Concerning the exemptions procedure, the Commission services, es timate that 3000-4000€ 
(based on a daily rate of 800€) for preparing, sending and following up (discussions with the 
consultant appointed by the Commi ssion, 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 aver age 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 th e man/hours spent by factor 10, still the amount 
would be negligible, compared to overall tu rnover of the EEE indust ry in EU, despite 
uncertainties and approximations. 
                                                
 
91 Administrative costs should be assessed on th e basis of the average cost of the required 
action (Price) multiplied by the total number of actions performed per year (Quantity). The 
average cost per action will be generally estimat ed by multiplying a tariff (based on average 
labour cost per hour including prorated overh eads) 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. 
 
EN 77   EN 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 na tional level either for manufacturers. In this 
respect, a strict interpretation of the "adminis trative cost" definition could lead us to the 
conclusion that RoHS does not create any admi nistrative burden for manufacturers, as far 
demonstration of compliance is concerned.  
Costs for testing may be significant but, as expl ained, in the majority of cases testing is not 
required; in most cases testing costs should be considered as cost fo r technical compliance, 
hence outside the definition of administra tive 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 st andards (ISO17025) that closely follow the 
guidelines of the informal network are available at 630€. However, the focus of 
manufacturers' effort as confirmed by dire ct communications with  manufacturers and the 
Arcadis report (p.104) is on "collecting and re viewing information" primarily from their 
suppliers so as to make sure that the purchased parts are RoHS compliant. 
In the absence of more de tailed information on the actu al cost for producing RoHS 
compliance documentation, the Commission services  base their estimation on the relationship 
of cost of exemption request/collecting and re viewing 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 cal culate 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 indi vidual recommended options). Nevertheless, the recommended 
options will have an important cumulative effe ct in clarifying the Directive and harmonising 
its implementation and enforcement with a positive contribution to better regulation.