Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment
Date: 2017-01-26
Institutions: Directorate-General for Environment, European Commission
Subjects: dangerous substance, electrical equipment, electronic component, electronic equipment, electronic waste, hazardous waste, machinery, market approval, musical instrument, waste recycling

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   EUROPEAN COMMISSION  Brussels, 26.1.2017  COM(2017) 38 final 2017/0013 (COD)   Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Text with EEA relevance) {SWD(2017) 22 final} {SWD(2017) 23 final}  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Directive  2011/65/EU  (RoHS  2)  sets  out  rules  on  the  restriction  of  the  use  of  certain 
hazardous substances in electrical and electronic equipment (EEE). RoHS 2 provisions apply 
to all EEE placed on the EU market regardless of whether they are produced in the EU or in 
third countries. RoHS 2 affects mainly industrial manufacturers, importers and distributors of 
EEE, as well as EEE customers. 

RoHS 2 addresses the waste hierarchy’s highest priority, waste prevention. Waste prevention 
includes  measures  that  reduce  the  content  of  harmful  substances  in  materials  and  products. 
Decreasing the amount of hazardous substances in electrical and electronic waste benefits the 
management of such waste as a result. It promotes the reuse of products and the recycling of 
used materials, which supports the circular economy. 

RoHS 2 is necessary to prevent barriers to trade and the distortion of competition in the EU, 
which  could  happen  in  case  of  disparities  between  the  laws  or  administrative  measures  on 
restricting  the  use  of  hazardous  substances  in  EEE  in  various  Member  States.  It  also 
contributes to the protection of human health and to the environmentally sound recovery and 
disposal of electrical and electronic waste. 

RoHS  2  is  a  recast  of  the  earlier  RoHS  Directive  2002/95/EC  (RoHS  1).  Both  RoHS 
directives  have  stimulated  a  reduction  in  hazardous  materials  all  over  the  world:  several 
countries, including China, Korea and the US, have developed RoHS-like legislation. 

RoHS  2  introduced  new  definitions  and  expanded  the  scope  to  cover  medical  devices  and 
monitoring  and  control  instruments.  The  impact  of  these  provisions  was  assessed  with  the 
Commission’s proposal in 2008. However, RoHS 2 also introduced further changes: the 'open 
scope' through a new category 11: "Other EEE not covered by any of the other categories". 
Those changes make the Directive applicable to all EEE (except equipment that is explicitly 
excluded)  and  give  a  broader  interpretation  of  EEE,  based  on  a  new  definition  of  the 
dependency on electricity. These 'open scope' provisions were not specifically assessed when 
introduced in RoHS 2. 

The Commission has a mandate to examine the need to amend the Directive’s scope in respect 
of the EEE definition and of additional exclusions of product groups covered by RoHS 2 by 
virtue of the open scope introduced with the 2011 recast. The Commission has carried out this 
assessment and identified a number of issues related to the scope of RoHS 2 that need to be 
addressed to avoid the legislation having unintended effects. 

In absence of a Commission proposal, the following problems would arise after 22 July 2019: 

– 

– 

– 

– 

the interdiction of secondary market operations (e.g. reselling, second-hand market) 
for new-in-scope EEE. This is known as the 'hard-stop'; 

the  stop  of  the  possibility  to  repair  with  spare  parts  a  subset  of  new-in-scope  EEE 
once legally placed on the market before that date; 

the different (distorting) treatment of cord-connected non-road mobile machinery in 
comparison  to  otherwise  identical  machinery  powered  by  a  battery  or  an  engine 
(currently excluded from RoHS scope); 

the  de-facto  prohibition  of  pipe  organs  placement  on  the  EU  market  (as  not 
RoHS-compliant due to the lead used to produce the wanted sound). 

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These  four  problems  could  affect  the  EU  market,  manufacturers  and  citizens  and  trigger 
negative economic, environmental, social and cultural impacts. 

The  Commission’s  proposal  therefore  tackles  scope  problems  that  cannot  be  resolved  by 
either  substance  substitution  or  exemptions  and  guidance,  e.g.  for  specific  product  groups 
with permanent compliance problem or  where  scope provisions generate market distortions, 
namely: 

  secondary  market  operations  for  RoHS  2  EEE  which  fell  outside  the  scope  of 

RoHS 1; 

  spare parts for RoHS 2 EEE which fell outside the scope of RoHS 1; 

 

traction-drive cord-connected non-road mobile machinery; 

  pipe organs. 

The proposal also addresses lessons learnt from implementing RoHS 2, in line with its overall 
objectives and legal clarity requirements. 

This initiative is not part of the REFIT agenda. 

Consistency with existing policy provisions 

By  addressing  secondary  market  operations,  the  proposal  aims  to  reinstate  RoHS 2  full 
coherence with the EU’s general principles of product legislation. In particular, as set out in 
the  Blue  Guide  providing  horizontal  guidance  on  the  role  of  market  placement  in  the  EU's 
product  legislation1:  ‘When  made  available  on  the  market,  products  must  be  in  compliance 
with  the  Union  harmonisation  legislation  applicable  at  the  time  of  placing  on  the  market. 
Accordingly, new products manufactured in the Union and all products imported from third 
countries  —  whether  new  or  used  —  must  meet  the  provisions  of  the  applicable  Union 
harmonisation  legislation  when  placed  on  the  market  i.e.  when  made  available  for  the  first 
time on the Union market. Compliant products once they have been placed on the market may 
subsequently  be  made  available  along  the  delivery  chain  without  additional  considerations, 
even in case of revisions to the applicable legislation or the relevant harmonised standards, 
unless otherwise specified in the legislation’. ‘Making available on the market’ and ‘placing 
on the market’ are defined in RoHS 2. Secondary market operations, such as reselling of EEE, 
which may involve also repair, spare parts replacement, refurbishment and reuse, are already 
allowed for most (but not all) of the EEE. 

(1) 

(2) 

1 

RoHS  2  allows  EEE  that  was  outside  the  scope  of  RoHS 1,  but  which  would  not 
comply with RoHS 2, to continue to be made available on the market until 22 July 
2019.  After  that  date  however,  both  the  first  placing  on  the  market  and  secondary 
market  operations  (e.g.  reselling)  of  non-compliant  EEE  will  be  prohibited.  EEE 
affected  by  this  'hard-stop'  of  secondary  market  operations  are  medical  devices, 
monitoring  and  control  instruments  and  other  new-in-scope  EEE.  This  barrier  to 
secondary market operations is not consistent with the general harmonisation of EU 
product  legislation.  For  this  reason,  the  Commission  proposes  to  remove  the  hard-
stop of secondary market operations. 

RoHS  2  creates  an  exception  (to  the  general  substance  restriction)  for  cables  and 
spare parts for the repair, reuse, updating of functionalities or upgrading of capacity 

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2016:272:TOC  

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the  groups  of  EEE  gradually  becoming  subject 

of 
its  scope.  However, 
newly-in-scope  EEE  other  than  medical  devices  and  monitoring  and  control 
instruments are not listed. This leads to the impossibility to use spare parts after 22 
July  2019  and  to  an  unjustified  difference  in  treatment.  The  Commission  therefore 
proposes  to  introduce  a  specific  provision  to  exclude  spare  parts  from  substance 
restriction, so to allow the repair at any time of all EEE in RoHS 2 scope, which were 
placed on the EU market. 

(3) 

RoHS 2 lists 10 specific kinds of equipment that are excluded from the ‘open scope’ 
provisions.  One  kind  of  equipment  that  is  excluded  (‘non  road  mobile  machinery 
made  available  exclusively  for  professional  use’)  only  includes  machinery  with  an 
on-board power source. This provision leads to types of machinery that are otherwise 
identical  to  be  under  two  different  regulatory  regimes  for  the  only  reason  of  their 
power  source  being  different  (on  board  or  external).  The  Commission  proposes  to 
amend the definition of ‘non road mobile machinery made available exclusively for 
professional use’ to also capture traction-driven machinery. 

(4) 

The Commission also proposes to add pipe organs to the list of excluded equipment 
due to the lack of alternatives for substitution. 

Under  RoHS 2,  exemptions  to  substance  restriction  should  have  a  defined  limited  duration, 
and  therefore  start  and  end  dates  for  exemptions  are  given  either  explicitly  in  the entries  of 
Annexes III and IV or implicitly through the maximum validity period in Article 5(2). Under 
the  current  Article 5(2),  however,  there  is  no  maximum  validity  period  specified  for 
category 11. 

Although Article 5(5) does not provide a specific deadline for the Commission's decision on 
applications for new exemptions, the timeframe for the Commission to decide on applications 
to renew an exemption is set for at the latest 6 months before the exemption expires, and this 
has proven to be unfeasible in practice. Combined with the requirement that an application for 
renewal  must  be  made  no  later  than  18  months  before  the  exemption  expires,  the  deadline 
means  that  the  Commission  must  make  its  decision  on  applications  to  renew  existing 
exemptions  within  twelve  months  after  the  application  is  submitted,  unless  specific 
circumstances justify a different deadline. Complying with this deadline is de facto unfeasible 
due to the several mandatory procedural steps needed for the evaluation of an application for 
renewal.  The  deadline  brings  no  additional  value  beyond  the  existing  transparent  procedure 
for  assessing  requests  for  renewal  and  retaining  a  deadline  which  has  proven  unfeasible  in 
practice  does  not  contribute  to  predictability  for  business  and  stakeholders.  Business 
continuity is in any case ensured since market operators can rely on an existing exemption to 
remain valid until a decision is taken on the renewal request. Therefore, the provision fixing a 
timeframe  for  the  Commission  to  decide  on  application  for  renewing  exemptions  should  be 
removed. 

Consistency with other EU policies 

The changes subject to the current proposal do not alter the fundamental approach of RoHS 2 
and its consistency with other legislation. RoHS 2 and the REACH Regulation are consistent 
in  terms  of  policy  interaction.  In  particular,  a  provision  on  coherence  with  REACH  is 
provided for both restricting new substances and granting exemptions from restriction. 

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RoHS  2  is  also  consistent  with  other  product-related  legislation,  such  as  Directive 
2012/19/EU of the European Parliament and of the Council on waste electrical and electronic 
equipment  and  Directive  2000/53/EC  of  the  European  Parliament  and  of  the  Council  on 
end-of-life  vehicles.  Other  EU  legislation,  for  example  on  medical  devices  or  occupational 
health  and safety,  may  contain independent obligations in  relation to  the use  phase of  EEE, 
but there are no overlaps with RoHS 2 requirements. 

2. 

LEGAL  BASIS,  SUBSIDIARITY,  PROPORTIONALITY  AND  LEGAL 
ELEMENTS OF THE PROPOSAL 

The legal basis of RoHS 2 and of this initiative is Article 114 of the Treaty on the Functioning 
of  the  European  Union  (TFEU),  the  objective  of  which  is  to  ensure  the  functioning  of  the 
internal  market  by  approximating  provisions  laid  down  by  law,  regulation  or  administrative 
action in Member States on the functioning of the internal market. 

The problems addressed by the current proposal cannot be solved without changing the scope 
of RoHS 2, as they originate in the current legal formulation of the RoHS 2 scope and related 
provisions. Only  a  solution  at  EU  level  can  solve  the  problems,  as  provisions regarding  the 
restriction of the use of hazardous substances in EEE being placed on the EU market have a 
direct impact on the EU single market and cannot be drawn up at Member State level without 
leading to distortion. 

The proposals are the only policy options capable of fully addressing the identified problems 
which  affect  the  EU  single  market  as  a  whole.  All  the  other  possible  policy  options  would 
neither  solve  the  identified  problems  permanently  and  in  their  entirety,  nor  ensure  legal 
certainty. 

The  impact  assessment  report  includes  further  indications  on  proportionality  of  the 
proposals.This  initiative  concerns  a  review  that  is  required  by  the  Directive.  The  directive 
revision  is  introduced  through  an  amending  directive,  the  content  of  which  is  explained 
below: 

Articles  1(1)(a)  and  1(3)(a)  change  the  transition  deadline  specified  in  the  current  RoHS 
Article 2(2) relating to the making available on the EU market of newly-in-scope EEE into a 
compliance date for placing on the EU market the same EEE specified in RoHS Article 4(3). 
This  follows  the  same  approach  as  for  all  the  other  product  groups  already  included  in  that 
provision. The amendment ensures legal clarity and consistency and removes the ‘hard-stop’ 
for  secondary  market  operations,  according  to  which  such  operations  would  not  have  been 
possible any longer after 22 July 2019 for the products concerned. 

Article 1(1)(b) excludes pipe organs from the scope of RoHS 2. 

Article  1(2)  broadens  the  definition  of  non-road  mobile  machinery  to  include  machinery 
powered by a cord-connected traction drive, in addition to similar machinery powered by an 
on-board  power  source.  As  a  consequence,  non-road  mobile  machinery  powered  through  a 
traction drive will be excluded from the scope of RoHS 2. 

Article  1(3)(b)  states  that  cables  or  spare  parts  for  the  repair,  the  reuse,  the  updating  of 
functionalities  or  upgrading  of  capacity  are  exempt 
for  all 
newly-in-scope EEE. This applies the same approach followed for other product groups. 

restrictions 

from 

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Article  1(4)(a)  establishes  the  maximum  validity  period  for  exemptions  applicable  to  the 
‘open  scope’  category  11  (i.e.  other  EEE  not  covered  by  any  of  the  other  categories).  The 
validity period for exemptions is already specified for the other categories. 

Article 1(4)(b) deletes the deadline for the Commission’s decision on the renewal of existing 
exemptions, reflecting practical experience and the fact that such deadline in practice does not 
bring additional certainty to applicants.  

3. 

STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS 

Stakeholder consultations 
Stakeholders  were  consulted  in  the  carrying  out  of  three  preparatory  Commission  studies2 
through specific websites; three 12-week open stakeholder consultations and four stakeholder 
meetings were held in 2012-2015. 

Around  three  hundred  experts,  representatives  from  Member  States,  industry  associations, 
manufacturers of EEE, environmental NGOs, consultancy companies and institutes, and other 
types  of  organisations  (e.g.  universities)  were  contacted.  Responses  from  around  forty 
participants  were  received  and  made  publicly  available.  Respondents  represented  mostly 
business and public authorities.  

When asked about their preferences for addressing the problems concerned, most respondents 
preferred:  

 

 

 

for the secondary market problem, removal of the ‘hard stop’ to secondary 
market operations for all newly-in-scope EEE and the transformation of the 
transition period into a compliance requirement by the same date;  

for the spare parts problem, introduction of a repair-as-produced provision;  

for  the  non-road  mobile  machinery  problem,  exclusion  from  the  RoHS 
scope of cord-connected twin machinery; 

 

for the pipe organ problem, a scope exclusion provision for pipe organs. 

Those options are seen as efficient, effective and safe solutions, and they have been reflected 
in the Commission proposal. 

Impact assessment 

Three  Commission  studies  were  conducted  in  2012-2015.  Related  studies  from  Member 
States were also taken into account. The impact assessment report received a positive opinion 
from  the  Regulatory  Scrutiny  Board  and  is  described  in  the  impact  assessment  summary 
sheet. 

The  Commission’s  proposed  measures  would  solve  the  four  identified  problems  and  would 
lead to the benefits discussed below; any negative impact would be limited or negligible. 

Restoring the secondary market and increasing spare part availability for certain EEE 
will have the following positive impacts: 

2 

http://ec.europa.eu/environment/waste/rohs_eee/studies_rohs4_en.htm 

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  A  reduction  of  costs  and  administrative  burden  both  for  business,  including  SMEs, 

and for public authorities; 

  Positive  economic  impact  in  terms  of  additional  market  opportunities  given  to  the 

repair industries and secondary selling; 

  Positive  social  impact,  including  for  EU  hospitals,  which  would  save  about  €170 
million after 2019, due to maintaining the possibility to resell and buy used medical 
devices;  

the  generation  of  hazardous  waste  (WEEE).  In  most  cases, 

  Environmental benefits in terms of reduced overall waste generation: the possibility 
of  prolonging  the  use  of  EEE  will  postpone  their  end-of-life  and  disposal,  thus 
delaying 
the 
environmental impact of producing additional spare parts is negligible in comparison 
with the advantage of keeping the entire equipment in use. This measure will prevent 
the creation of more than 3000 tonnes of hazardous waste per year in the EU, which 
would support the circular economy initiative. The longer lifetime of EEE would also 
lead to additional savings of energy and raw materials. 

The  exclusion  of  pipe  organs  from  the  Directive’s  scope  will  help  avoid  the  loss  of  up  to 
90%  of  jobs  in  the  sector  and  the  annual  loss  of  up  to  € 65  million  by  2025.  A  significant 
cultural loss — the pipe organs manufacture, maintenance and, gradually, also their use being 
abandoned — is also avoided.  

The exclusion of non-road mobile machinery powered through a traction drive from the 
Directive’s scope  will  support  industry  development  in  the  sector  by  removing  distortion  in 
the treatment of machinery. In the EU cleaning machinery sector, for example, the proposal 
will allow 14 000 cord connected units to be placed on the market each year (with a turnover 
of  300  million  €),  preventing  any  risk  of  eliminating  these  machinery  models  from  the  EU 
market.  It  will  also  reduce  costs  and  unnecessary  administrative  burden  both  for  business, 
including SMEs, and for public authorities. 

4. 

BUDGETARY IMPLICATIONS AND OTHER ELEMENTS 

This legislative proposal has no budgetary implications. 

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2017/0013 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directive 2011/65/EU on the restriction of the use of certain hazardous 
substances in electrical and electronic equipment 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee3, 
Having regard to the opinion of the Committee of the Regions4, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

3 
4 
5 

6 

Article 24(1) of Directive 2011/65/EU of the European Parliament and of the Council5 
on the restriction of the use of certain hazardous substances in electrical and electronic 
equipment (EEE) requests that the Commission examine the need to amend the scope 
of  Directive  2011/65/EC  in  respect  to  the  EEE  therein  covered  and,  if  appropriate, 
present a legislative proposal with respect to any additional exclusions related to that 
EEE. 

Secondary market operations for electrical and electronic equipment (EEE), involving 
repair,  replacement  of  spare  parts,  refurbishment  and  reuse,  should  be  facilitated  to 
promote a circular economy in the Union. A high level of protection of human health 
and the environment should be ensured, including through the environmentally sound 
recovery  and  disposal  of  waste electrical  and  electronic  equipment.  Unnecessary 
administrative  burden  on  market  operators  should  be  avoided.  Directive  2011/65/EU 
allows  EEE  that  fell  outside  the  scope  of  the  previous  Directive  2002/95/EC  of  the 
European Parliament and of the Council6, but which would not comply with Directive 
2011/65/EU, to continue to be made available on the market until 22 July 2019. After 
that  date,  however,  both  the  first  placing  on  the  market  and  secondary  market 

OJ C , , p. . 
OJ C , , p. . 
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, 
p. 88). 
Directive  2002/95/EC  of  the  European  Parliament  and  of  the  Council  of  27  January  2003  on  the 
restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 37, 
13.2.2003, p. 19). 

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operations  of  non-compliant  EEE  are  prohibited.  Such  prohibition  of  secondary 
market  operations  is  inconsistent  with  the  general  principles  underlying  Union 
measures  for  the  approximation  of  laws  relating  to  products  and  should  therefore  be 
removed.  

scope  of 
Certain  niche  product  groups 
Directive 2011/65/EU  as  their  inclusion  would  bring  negligible  environmental  or 
health  benefits  and  introduce  unresolvable  compliance  problems  or  distortion  that 
cannot effectively be addressed through the exemption mechanism provided for in that 
Directive. 

should  be  excluded 

from 

the 

Pipes  in  organs  are  built  using  a  specific  type  of  lead-based  alloy,  for  which  no 
alternative  has  been  found  so  far.  Most  pipe  organs  are  kept  in  the  same  place  for 
centuries  and their turn-over rate is negligible. Pipe  organs should be excluded from 
the  scope  of  Directive  2011/65/EU  as  their  inclusion  would  bring  negligible  benefit 
with regard to the substitution of lead. 

Directive 2011/65/EU does not apply to non-road mobile machinery with an on-board 
power  source  and  made  available  exclusively  for  professional  use.  However,  for 
certain  types  of  non-road  mobile  machinery,  two  versions  are  produced  in  the  same 
production  line,  with  the  power  source  (on-board  or  external)  being  the  only 
difference.  Those  versions  should  be  treated  in  the  same  way  under  that  Directive. 
Non-road  mobile  machinery  with  a  traction  drive  powered  by  an  external  power 
source should therefore also be excluded from the scope of Directive 2011/65/EU. 

As exemptions from the restriction on the use of certain hazardous substances should 
have a limited duration, the maximum validity period for existing exemptions should 
be clearly defined for all relevant EEE categories, including for category 11 as set out 
in Annex I to Directive 2011/65/EU. 

(3) 

(4) 

(5) 

(6) 

(7)  When  an  application  for  renewal  of  an  exemption  is  submitted,  the  Commission  is 
required to take a decision no later than 6 months before the expiry date of the existing 
exemption,  unless  specific  circumstances  justify  a  different  deadline.  No  deadline  is 
specified for the Commission to take a decision on applications for new exemptions.  
According  to  the  report  from  the  Commission  to  the  European  Parliament  and  the 
Council  on  the  exercise  of  the  power  to  adopt  delegated  acts  conferred  on  the 
Commission  pursuant  to  Directive 2011/65/EU7,  that  deadline  has  proven  to  be 
unfeasible  in  practice,  due  to  the  several  mandatory  procedural  steps  needed  for  the 
evaluation of an application for renewal. While the deadline brings no additional value 
to  the  existing  procedure  of  examination  of  requests  for  renewals,  it  entails 
uncertainties for businesses and other stakeholders due to its impracticability. Business 
continuity  is  ensured  since  market  operators  may  rely  on  an  existing  exemption 
remaining  valid  until  a  decision  is  taken  on  the  renewal  request.  Therefore,  the 
provision related to the deadline should be removed. 

(8) 

Since the objectives of this Directive to contribute to the protection of human health 
and the environmentally sound recovery and disposal of waste electrical and electronic 
equipment  by  the  means  of  restriction  on  the  use  of  hazardous  substances  in  EEE  
cannot be sufficiently achieved by the Member States as disparities between the laws 
or  administrative  measures  adopted  by  the  Member  States  could  create  barriers  to 
trade and distort competition in the Union and thus have a direct impact on the internal 

7 

COM(2016) 215 final of 18 April 2016. 

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market,  but  can  rather,  by  reason  of  the  scale  of  the  problem  and  its  implications  in 
respect  of  other  Union  legislation  on  recovery  and  disposal  of  waste  and  areas  of 
common interest, such as human health protection, be better achieved at Union level, 
the Union may adopt measures, in accordance with the principle of subsidiarity as set 
out in Article 5 of the Treaty on European Union. In accordance with the principle of 
proportionality  as  set  out  in  that  Article,  this  Directive  does  not  go  beyond  what  is 
necessary in order to achieve those objectives, 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 2011/65/EU is amended as follows: 

(1) Article 2 is amended as follows: 

(a) paragraph 2 is deleted; 

(b) in paragraph 4, the following point (k) is added: 

‘(k) pipe organs.’; 

(2) in Article 3, point (28) is replaced by the following: 

‘non-road mobile machinery made  available exclusively for professional use’ 
‘(28) 
means  machinery,  with  an  on-board  power  source  or  with  a  traction-drive,  the 
operation  of  which  requires  either  mobility  or  continuous  or  semi-continuous 
movement  between  a  succession  of  fixed  working  locations  while  working,  and  is 
made available exclusively for professional use.’; 

(3) Article 4 is amended as follows: 

(a) paragraph 3 is replaced by the following: 

‘3. Paragraph 1 shall apply to medical devices and monitoring and control instruments 
which  are  placed  on  the  market  from  22  July  2014,  to  in  vitro  diagnostic  medical 
devices  which  are  placed  on  the  market  from  22  July  2016,  to  industrial  monitoring 
and control instruments which are placed on the market from 22 July 2017 and to all 
other EEE that was outside the scope of Directive 2002/95/EC which is placed on the 
market from 22 July 2019.’; 

(b) in paragraph 4, the following point (ea) is inserted: 

‘(ea) all other EEE that was outside the scope of Directive 2002/95/EC and is placed 
on the market before 22 July 2019;’ ; 

(4) Article 5 is amended as follows: 

(a) in paragraph 2, the second subparagraph is replaced by the following: 

‘For the exemptions listed in Annex III as at 21 July 2011, unless a shorter period is 
specified, the maximum validity period, which may be renewed, shall be: 

(a) for categories 1 to 7 and category 10 of Annex I, 5 years from 21 July 2011; 

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(b)  for  categories  8  and  9  of  Annex  I,  7  years  from  the  relevant  dates  laid  down  in 
Article 4(3);  

(c) for category 11 of Annex I, 5 years from 22 July 2019.’; 

(b) in paragraph 5, the first sentence of the second subparagraph is deleted. 

Article 2 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  by  [insert  date  ten months  after 
the entry into force of this Directive] at the latest. They shall forthwith communicate 
to the Commission the text of those provisions. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 3 

This Directive is addressed to the Member States. 

Done at Brussels, 

Article 4 

For the European Parliament 
The President 

For the Council 
The President 

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