EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
amending Annex II to Directive 2011/65/EU of the European Parliament and of the 
Council as regards the list of restricted substances 
(Text with EEA relevance) 
 EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Subject: Commission Delegated Directive amendi ng Annex II to Directive 2011/65/EU of the 
European Parliament and of the Council as re gards the list of restricted substances. 
Directive 2011/65/EU of the European Parl iament and of the C ouncil of 8 June 2011 
(RoHS 2) entered into force on 21 July 2011. RoHS 2 restricts the use of certain hazardous substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) in  electrical and electronic e quipment (EEE). The restricted 
substances are listed in Annex II to RoHS 2. 
Article 6(1) of RoHS 2 establis hes a procedure for a periodic re view of Annex II and sets the 
date for the first review: "With a view to achieving the obj ectives set out in Article 1 and 
taking account of the precauti onary principle, a review, bas ed on a thorough assessment, and 
amendment of the list of restricted substanc es in Annex II shall be considered by the 
Commission before 22 July 2014, and periodically thereafter  […]." 
Pursuant to Article 6(3) of RoHS 2, the "measures referred to in th is Article shall be adopted 
by the Commission by means of delegated acts ." 
In order to avoid inconsistencies with REAC H, the classification of substances and any 
available substance-specific information under REACH, including the regulatory processes of 
authorisation and restric tion, shall be considered: "The review and amendment of the list of 
restricted substances in Annex II shall be cohere nt with other legislation related to chemicals, 
in particular Regulation (EC) No 1907/2006, and s hall take into account,  inter alia, Annexes 
XIV and XVII to that Regulation. The review sh all use publicly available knowledge obtained 
from the application of  such legislation." 
Recital 16 of RoHS 2 states that  the review and amendment of th e list of restricted substances 
in Annex II should also "reflect the complementary nature of  the work carried out under other 
Union legislation, and in particular under Re gulation (EC) No 1907/2006 while ensuring the 
mutually independent operation of this Directive and that Regulation." 
The position of the Commission is that the REACH reference in RoHS 2 does not indicate 
that the procedure should be fully aligned or the criteria for a restrict ion under RoHS 2 are 
necessarily the same as under REACH. It is however important to a void double regulation or 
conflict between the two legislative instruments. Under RoHS 2, "in order to review and 
amend Annex II, the Commission shall take specia l account of whether a substance […] or a 
group of similar substances: 
(a) could have a negative  impact during EEE wast e management operations , including on 
the possibilities for preparing for the reuse of waste EEE or for recycling of materials from waste EEE; 
(b) could give rise, given its us es, to uncontrolled or diffuse  release  into the environment of 
the substance, or could give rise to hazardous  residues, or transformation or degradation 
products through  the preparation for reuse, recycling or other treatment of materials from 
waste EEE under current operational conditions;  
(c) could lead to unacceptable exposure of workers involved in the waste EEE  collection or 
treatment  processes; 
(d) could be replaced by substitutes or alternative technologies which have less negative 
impacts." EN 3   EN In its Common Understanding Paper on REACH and RoHS of 9 July 20141, the Commission 
clarified that RoHS 2 is the preferred legal instrument for tackling substance-related issues in electrical and electroni c products. In order to ensure c oherence between REACH and RoHS 2, 
the Paper sets out agreed approaches to certain scenarios, in particular for substances already 
subject to authoris ation or restriction under REACH. It is  also important to note that although 
the inclusion of a substance in Annex XIV to REACH (authorisation list) only affects 
manufacturing and does not prevent finished  products containing this substance being 
imported into the EU, Article 69(2) of REAC H requires the European Chemicals Agency 
(ECHA) to consider whether the use of the substa nce in articles poses a risk to human health 
or the environment. If it does, a restricti on may be imposed which can address imports. 
As regards the first RoHS 2 substance review, Recital 10 names the  highest priority 
substances : "In particular, the risks to human health  and the environment arising from the 
use of Hexabromocyclododecane (HBCDD), Bi s (2-ethylhexyl) phthalate (DEHP), Butyl 
benzyl phthalate (BBP) and Dibut yl phthalate (DBP) should be considered as a priority. With 
a view to further restrictions of substan ces, the Commission should re-investigate the 
substances that were subject to previous assessments […]." 
Pursuant to Article 6(1) of RoHS 2, the fi rst review of Annex II was due July 2014. The 
Commission published an open call and launche d a preparatory study in November 2012. The 
consultants (Environmental Agency Vie nna, UBA) developed a methodology for the 
identification, pre-assessment and assessment of  substances that is EEE-specific and does not 
contradict REACH knowledge and provisions. The aim was to produce a sound basis for 
future reviews that can also be applied to fu ture Member State submissions as suggested by 
Article 6 of RoHS 2. They also applied this  methodology to the above mentioned priority 
substances DEHP, BBP, DBP  (three common phthalate plasticisers) and HBCDD  (a 
brominated flame retardant) and, based on this assessment, recommended a restriction of all 
four. An additional result of the pre-assessment was a list of 24 priority substances for future 
reviews. Final versions of all documents  are available since end of January 2014.
2 
As a follow-up, in order to avoid detrimenta l substitution effects from one problematic 
halogenated plasticiser to a nother, the Commission mandated Ro HS consultants Oeko-Institut 
("Oeko") under an existing framework contract  in November 2013 with the assessment of 
DIBP (diisobutyl phthalate) according to the newly developed methodology. DIBP had come up as a top priority substance in UBA's a bove mentioned prioriti sation exercise. Oeko's 
recommendation published in June 2014 was to give DIBP  the same treatment as the other 
three phthalates above.
3 
                                                 
1 
http://ec.europa.eu/geninfo/query/ resultaction.jsp?QueryText=rohs+a nd+reach&query_source=ENTERPRISE&s
wlang=en#queryText=rohs+and+r each&tab=restricted&customsort=date&filterNum=0&summary=summary . 
2 Direct links to substance evaluations and recommendations: 
http://www.umweltbundesamt.at/filead min/site/umweltthemen/abfall/ROHS/ finalresults/Annex5_RoHS_AnnexI
I_Dossier_HBCDD.pdf  [HBCDD]; 
http://www.umweltbundesamt.at/filead min/site/umweltthemen/abfall/ROHS/ finalresults/Annex6_RoHS_AnnexI
I_Dossier_DEHP.pdf  [DEHP]; 
http://www.umweltbundesamt.at/filead min/site/umweltthemen/abfall/ROHS/ finalresults/Annex7_RoHS_AnnexI
I_Dossier_BBP.pdf  [BBP]; 
http://www.umweltbundesamt.at/filead min/site/umweltthemen/abfall/ROHS/ finalresults/Annex8_RoHS_AnnexI
I_Dossier_DBP.pdf  [DBP]. 
3 http://rohs.exemptions.oeko.info/fileadmin/user_upl oad/reports/20140520_DIBP_AnnexII_Dossier_final.pdf  
[DIBP]. EN 4   EN 2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT 
Pursuant to Article 6(1) of RoHS  2, any review of the list of restricted subs tances in Annex II 
requires the consultation of "interested parties, including ec onomic operators, recyclers, 
treatment operators, environmental organisati ons and employee and consumer associations." 
In line with the provisions fo r the review of Annex II, th e Commission launched the above 
mentioned two studies and carri ed out the requisite technical  and scientific assessment 
including five official stake holder consultations and three o fficial stakeholder meetings.4 The 
two final reports are available on  the consultants' webpages; st akeholders and Member States 
were notified thereof. The project page is  accessible via the DG Environment webpage.5 
Subsequently, the Commission consulted the o fficial expert group fo r delegated acts under 
RoHS 2. A meeting with consultants and e xperts was held on 25 June 2014, a consolidated 
recommendation with all necessary background in formation was sent out on 1 July 2014 and 
experts were invited to comment on th e draft by 25 August 2014. The expert group 
unanimously supported the draft. All necessary steps pursuant to Article 6 of RoHS 2 have 
been performed. The Council an d the Parliament were notified of all activities of the 
delegated acts expert group via th eir official functional mailboxes. 
Technical background information  (for further information see footnotes 2 and 3): 
HBCDD  is a brominated flame retardant. It is  a substance of very high concern (SVHC)6; it is 
persistent and undergoes long range transport; it accumulates in the food chain, is reprotoxic 
and accumulates in human breast milk. Although the consultants recommended the restriction 
of HBCDD, the Commission considered a ban disp roportionate and refrained from it for the 
following reasons: On 22 May 2013 the Stoc kholm Convention on Persistent Organic 
Pollutants (POPs) decided to include HBCDD in  the Convention’s Annex A for elimination, 
with specific exemptions only for expande d (EPS) and extruded po lystyrene (XPS) in 
buildings. Japan was the first country to impl ement a ban on the import and production of 
HBCDD effective since May 2014. A complete phase-out of HB CDD in electronics, whether 
imported or produced in Europe, will only be a matter of years. In relation to the REACH 
authorisation process for HBCDD,  ECHA did not receive an app lication for authorisation for 
any specific use in EEE. This confirms that  in Europe HBCDD is not used in EEE. 
DEHP, BBP, DBP, DIBP:  
DEHP  is the most common plasticiser used in PVC.  It is a substance of  very high concern.7 
DEHP is a widespread environmental polluta nt, found in the food chain and in the human 
diet. 
The majority of environmental releases of DE HP from relevant WEEE treatment processes 
are releases to air. The total a nnual releases are estimated to be  0.9 to 6.8 tonnes. In addition, 
releases of DEHP are also expected from landfills, incineration plants and uncontrolled treatment of WEEE. Estimates of the number  workers exposed to DEHP releases range 
                                                
 
4 The consultation list is regularly updated and main tained by the consultants in cooperation with the 
Commission, and includes electronics related industry organisations, manu facturers and suppliers, recyclers, 
consumer associations, NGOs, academia, Member States ' representatives, etc. DG  Enterprise was actively 
involved in all activities. 
5 http://ec.europa.eu/environment/w aste/rohs_eee/review/index_en.htm . 
6 ECHA Decision ED/67/2008; http://echa.europa.eu/documents/10162/2bbe3f6b-4ef6-4586-b4bc-
66f9a6c7a894 . 
7 http://echa.europa.eu/documents/10162/2bbe3f6b-4ef6-4586-b4bc-66f9a6c7a894 . EN 5   EN between 2,250 and 6,750. The European risk assessment report on DEHP8 concludes that 
there is a need to limit the risks from use of DEHP at workplaces. 
Taking into account the regulations pertaining to the use of DEHP (e.g. under REACH) it is 
expected that the recycling possibilities for PV C will be reduced due to the presence of DEHP 
in WEEE plastics. Currently recycled PVC is used for the production of low value articles. 
Thus it is not expected that DEHP will stay in the recycling loop for long. Waste with a DEHP content of 0.5% is considered hazardous. Assuming a separating and shredding rate of 
80% for all WEEE cables, the estimated amount of hazardous waste generated per year is 
110,000 tonnes. 
Detailed assessments on possible alternatives were carried out recently on behalf of the 
European Chemicals Agency and the Danish Ministry of Environment.
9 Besides the hazard 
profiles of such substitute s, their use and technical feasibility were assessed.10 The results of 
these assessments show that the substitution of DEHP by less harmful substances is possible and already being done. Possible alternatives  are DINP (Di-isononyl phthalate, DIDP (Di-
isodecyl phthalate), DINCH (Di-isononyl-cyc lohexane-1,2-dicarboxylate) and ASE 
(Alkylsulfonic phenyl es ter). In general, the use of DEHP  in EEE is not considered to be 
essential, although there are still uncertainties about the safety of possible alternatives in 
particular in the medical sector.
 
In total, a ban on DEHP in EEE would create very limited additiona l costs while creating 
substantial additional benefits for health, e nvironment and the economy. The overall impact 
on jobs/employment is expected to be small. W ith respect to the benefits, however, the impact 
of a DEHP ban is expected to be substantial: 
• Increase in the competitive position of  an environmentally friendly industry; 
• Global reduction of environmental and h ealth impacts from DEHP and plastics 
production; 
• Reduction of the environmental and hea lth impact from the use of DEHP 
containing EEE and especially of im pacts arising during the waste and 
recycling phase. 
DEHP should therefore be included in  Annex II to the RoHS 2 Directive. A restriction of 
DEHP under RoHS 2 is considered to be an  appropriate measure to reduce any negative 
impacts from or on WEEE management because: 
• A risk for the environment (secondary poisoning of mammalians and birds) 
must be expected from the relevant  WEEE treatment processes (i.e. the 
handling of materials at shredder sites, shredding of cables and recycling of 
PVC derived from WEEE). Occupational exposure estimates for workers in 
WEEE treatment plants indicate that it is possible that exposure exceeds the 
safe exposure levels deri ved by the risk assessment committee of the European 
Chemicals Agency. Therefore, a risk  for workers cannot be excluded; 
                                                 
8 http://echa.europa.eu/documents/10162/060d4981-4dfb-4e40-8c69-6320c9debb01 . 
9 COWI 2009, Data on manufacture, import, export, uses and releases of Bis(2-ethylhexyl) phthalate (DEHP) as 
well as information on potential alternatives to its use; and Danish Environmental Protection Agency 2011, 
Annex XV Restriction Report. Proposal for a restriction. Substance name: Bis(2-Ethylhexyl) phthalate (DEHP); 
Benzyl butyl phthalate (BBP); Dibutyl phtha late (DBP); Diisobutyl phthalate (DIBP). 
10 Summary and further references: 
http://www.umweltbundesamt.at/filead min/site/umweltthemen/abfall/ROHS/ finalresults/Annex6_RoHS_AnnexI
I_Dossier_DEHP.pdf ,  p. 55. EN 6   EN • DEHP releases from sites for the mech anical treatment of WEEE and cables 
and from PVC recycling are relevant contributors to the overall releases to air 
from treatment of DEHP-containing wast es in a scenario where measures for 
preventing dust emissions are insufficient; 
• There are considerable negative impacts on waste management (reduced 
recycling possibilities due to  regulations for DEHP, generation of considerable 
amounts of hazardous waste); 
• Alternatives with less negative properties are available and technically and 
economically feasible; 
• The socio-economic impact analysis indicat es that a restriction of DEHP would 
have several benefits, including reduced  risks and a less negative impact on 
waste management. Additional costs would be incurred in some sectors, i.e. by producers of chemicals and in the production of EEE. 
A restriction of DEHP in EEE would therefore be  fully in line with the requirements and 
criteria of Article 6(1) of Ro HS 2. The proposed maximum concentration value of DEHP 
to be tolerated in EEE is 0.1 weig ht % per homogeneous material.  Given the level of risk 
estimated by the Commission’s consultants when assuming a DEHP concentration in PVC of a few %, it can be expected that a maximum c oncentration of 0.1 weight %, which is the limit 
value for all other rest ricted substances under RoHS excep t cadmium, will al ready lead to 
significantly reduced risks. 
The situation regarding BBP and DBP  is similar. Both substances are SVHC and classified as 
toxic to reproduction.
11 A risk for workers was identified for DBP for industrial processes in 
Europe in 2003, with concerns for general systemic toxicity as a consequence of repeated dermal exposure arising from aerosol forming activ ities, as well as con cerns for adverse local 
effects in the respiratory tract as a consequen ce of repeated inhalation exposure. The majority 
of environmental releases of  BBP and DBP from relevant WEEE treatment processes are 
releases to air. 
Alternatives are available. In addition to th e alternatives mentioned under DEHP, potential 
substitutes are DGD (Dipropylene glycol di-b enzoate) and GTA (Glycerol triacetate).
12 BBP 
and DBP are not as widely used in EEE as DEHP and industry was reluctant to provide 
accurate data in the course of the various stakeholder consultations, although specific 
applications such as capacitors could be identifie d. Even on the basis of a worst case scenario 
regarding the amounts of BBP and DBP potentially used in electronics, the overall socio-
economic impact of a restriction under RoHS 2 is expected to be very small. This impact 
assessment covers both substitution and complia nce documentation costs. With respect to the 
benefits, however, the impact of a ba n is expected to be substantial. BBP and DBP should 
therefore be included in Annex II to the Ro HS 2 Directive. The proposed maximum 
concentration value per substance to be  tolerated in EEE is 0.1 weight % per 
homogeneous material. For BBP listed in Annex XIV to  REACH, no application for 
authorisation for use in EEE has been received so far; theref ore after the sunset date of 
February 2015, the use of BBP in the pr oduction of EEE in Europe will be banned. 
                                                 
11 http://echa.europa.eu/documents/10162/2bbe3f6b-4ef6-4586-b4bc-66f9a6c7a894 . 
12 
http://www.umweltbundesamt.at/filead min/site/umweltthemen/abfall/ROHS/ finalresults/Annex7_RoHS_AnnexI
I_Dossier_BBP.pdf , p. 38; and 
http://www.umweltbundesamt.at/filead min/site/umweltthemen/abfall/ROHS/ finalresults/Annex8_RoHS_AnnexI
I_Dossier_DBP.pdf , p. 37. Cf. also footnote 10. EN 7   EN Regarding DIBP , which is also a substance of very high concern because of its reproductive 
toxicity13, the situation is slightly different. Available data collected by the Commission’s 
consultants suggests that DIBP is currently not us ed in traditional EEE. It  is however used as 
a plasticiser in glues and inks for paper and food packaging, and in toys, childcare articles and 
a wide range of consumer products , some of which indeed might be in the scope of RoHS 2. 
Moreover, DIBP has similar properties as DBP and can be used as a substitute for it. In a scenario where DIBP instead of DBP would be used in EEE, the assessment would be the 
same as for DBP, and a restric tion would become necessary in any case. Consultants therefore 
recommend that measures against DIBP in EEE u nder RoHS 2 should be tie d to the restriction 
of the other three phthalates in order to avoid "regrettable substitution". The same logic was applied when DIBP was added to Annex XIV to REACH. DIBP should therefore be 
included in Annex II to the RoHS 2 Directiv e. The proposed maximum concentration 
value per substance to be tolerated in EE E is 0.1 weight % per homogeneous material. 
As no application for authorisation for use in E EE has been received so far, after the sunset 
date of February 2015, the use of DIBP in the production of EEE in Europe will be banned. 
The decision to restrict DEHP, BBP, DBP and DIBP under RoHS is coherent with and 
complementary to REACH. The consultants’ as sessment is consistent with available REACH 
data, which were used in the evaluation, and the substance classification under REACH. The 
restriction is also fully in line with th e Commission’s Common Un derstanding Paper on 
REACH and RoHS of 9 July 2014 (see above). 
DEHP, BBP and DBP have been restricted in toys for nearly a decade through entry 51 of 
Annex XVII to REACH. Toys containing these phthalates in a concen tration greater than 
0.1% (calculated for the three phthalates cumulativ ely) by weight of the plasticised material 
cannot be placed on the EU ma rket. Avoidance of double regul ation of EEE toys by RoHS 2 
will be ensured by stipulating that the long-stan ding, stricter restricti on in entry 51 of Annex 
XVII to REACH will continue to be the only re striction applicable to DEHP, BBP and DBP 
in EEE toys. This preserves the established conc entration calculation for toys of 0.1% for the 
three phthalates in combination and avoids any relaxation of the restriction (by calculating 
concentration on the basis of 0.1% per phthalate). 
With regard to authorisations under REACH, there will be a need to ensure coherent 
administration of any adaptation to technical progress of Annex III or  IV of RoHS 2 to 
exempt certain applications of DEHP and DB P and any authorisatio n granted under REACH. 
Applications for authorisation ha ven been received for these tw o phthalates including uses in 
EEE. 
In order to allow a smooth transition and to mitigate possible minor socioeconomic impacts, 
an appropriate transition pe riod should be granted. Extensiv e discussions with sectoral 
stakeholders showed that 22 July 2019 is a realistic complia nce date for the majority of 
EEE, while 22 July 2021 should be sufficient for RoHS 2 Annex I categories 8 and 9, i.e. 
medical devices including in vitro medi cal devices and monitoring and control 
instruments including industrial mo nitoring and control instruments.  This gradual 
approach is coherent with the gradual extension of RoHS restrictions in Article 4(3) of RoHS 
2 and respects the higher re liability requirements and long er innovation cycles of product 
categories 8 and 9. It will also help ensure legal certainty and allow all economic operators to 
identify problem areas and submit applicatio n specific exemption requests for the newly 
                                                
 
13 ECHA Decision ED/68/2009; http://echa.europa.eu/documents/10162/3b3b4e1d-f47b-43d1-9726-
e25f959bd110 . EN 8   EN banned substances well ahead of the deadline.14 This timetable will also give the Commission 
enough time to deal with these requests and gr ant an exemption where the substitution is 
indeed inappropriate purs uant to the criteria of Article 5(1) of RoHS 2 and the use of a 
restricted substance should be tolerated beyond the respective compliance date. The exact date 
is aligned with the compliance date in Article 2(2) of RoHS 2 for products newly included in 
the scope and will therefore facilitate proce dural efforts (documentation etc.) for economic 
operators. 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT 
The act adds the four phthala tes DEHP, BBP, DBP and DIBP to  the list of restricted 
substances in Annex II to Directive 2011/65/EU (RoHS 2). 
The instrument is a delegated directive. The delegated directive implements Directiv e 2011/65/EU, and in part icular Article 6(3) 
thereof. 
The objective of the act is to ensure legal certainty and sustainabl e market conditions for 
electronic manufacturers, to establish a level pl aying field for EU and non-EU manufacturers 
and to facilitate EEE recycli ng by phasing out problematic substances, while granting an 
appropriate transition period in order to allow economic operators  to apply for the exemption 
of specific applications of these substances in line with the provisi ons of RoHS 2 and the 
procedure established in Article 5 of RoHS 2 for the adaptation of A nnexes III and IV to 
scientific and technical progress. 
In accordance with the principle of proportiona lity, the measure does not go beyond what is 
necessary to achieve its objective. 
The act has no implications for the EU budget. 
                                                
 
14 The medical sector already submitted a draft list and phase-out timetable for DEHP, DBP and BBP on 23 
October 2014. EN 9   EN COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
amending Annex II to Directive 2011/65/EU of the European Parliament and of the 
Council as regards the list of restricted substances 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2011/65/EU of the Eu ropean Parliament and of the Council of 8 
June 2011 on the restriction of the use of cert ain hazardous substances in electrical and 
electronic equipment,
15 and in particular Article 6(3) thereof, 
Whereas: (1) Directive 2011/65/EU lays down rules on th e restriction of the use of hazardous 
substances in electrical and electronic equipment (EEE) with  a view to contributing to 
the protection of human health and the e nvironment, including the environmentally 
sound recovery and disposal of waste EEE. 
(2) Directive 2011/65/EU prohibits the use of lead, mercury, cadmium, hexavalent 
chromium, polybrominated biphenyls (PBB)  and polybrominated diphenyl ethers 
(PBDE) in electrical and electronic equi pment placed on the Union market. Annex II 
to that Directive lists those restricted substances. 
(3) The risks to human health and the e nvironment arising from the use of 
Hexabromocyclododecane (HBCDD), Bis (2-e thylhexyl) phthalate (DEHP), Butyl 
benzyl phthalate (BBP) and Dibutyl phthalate (DBP) should be considered a priority in 
the periodic review of the list of restricted substances in  Annex II. With a view to 
further restrictions, the substances that were  subject to previous assessments should be 
re-investigated. 
(4) In accordance with Article 6(1) of Directiv e 2011/65/EU, interested  parties, including 
economic operators, recyclers, treatment ope rators, environmental organisations and 
employee and consumer associations, have been consulted and a thorough assessment has been performed. 
(5) Bis (2-ethylhexyl) phthalate (D EHP), Butyl benzyl phthalate  (BBP), Dibutyl phthalate 
(DBP) and Diisobutyl phthalat e (DIBP) are substances of  very high concern (SVHC). 
DIBP is a substance that can be used as a substitute for DBP and was subject to previous assessments performed by the Co mmission. The available evidence indicates 
that those four substances, when used in EEE, can have a negative impact on recycling 
and on human health and the environmen t during EEE waste management operations. 
(6) Substitutes that have less negative impact s are available for DEHP, BBP, DBP and 
DIBP in most EEE. The use of those substa nces in EEE should therefore be restricted. 
DEHP, BBP and DBP are already restricted  through entry 51 of Annex XVII to 
                                                
 
15 OJ L 174, 1.7.2011, p. 88.  EN 10   EN Regulation (EC) No 1907/2006 of the Eur opean Parliament and of the Council,16 so 
that toys containing DEHP, BBP or DBP in  a concentration greater than 0,1 % by 
weight of the plasticised material, calculated for the three phthalates cumulatively, cannot be placed on the EU market. In orde r to avoid double regulation, the restriction 
through entry 51 of Annex XVII to  that Regulation shall ther efore continue to be the 
only restriction applicable to  DEHP, BBP and DBP in toys. 
(7) In order to facilitate transition and to mitigate possible socioeconomic impacts, an 
appropriate transition period sh ould be granted, which wi ll allow economic operators 
to apply for exemptions from the substance re strictions in accordanc e with Article 5 of 
Directive 2011/65/EU. The l onger innovation cycles for medical devices and 
monitoring and control instruments should be  taken into account while determining 
the transitional period. The restriction of the use of DEHP, BBP, DBP and DIBP 
should therefore apply to medical devices, including in vitro medical devices, and 
monitoring and control instruments, incl uding industrial monitoring and control 
instruments, from 22 July 2021. 
(8) Any adaptation of Annexes III or IV to Di rective 2011/65/EU to exempt applications 
in relation to DEHP or DBP should take pl ace in a manner which, in order to avoid 
double regulation and unnecessary burden, ensures coherence with the administration of any authorisation grante d under Regulation (EC) No 1907/2006 in relation to the 
incorporation of those substa nces in EEE. Operators consid ering whether to apply for 
exemptions under Directive 2011/65/EU shoul d be aware that such exemptions may 
cover the entire life cycl e of the EEE, including the manufacturing phase. 
(9) Directive 2011/65/EU should therefore be amended accordingly,  
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex II to Directive 2011/65/EU is replaced by the text in the Annex to this Directive. 
Article 2 
1. Member States shall adopt and publish, by 31 December 2016 at the latest, the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Co mmission the text of those provisions. 
They shall apply those provisions from 22 July 2019. 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 determin e 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. 
                                                
 
16 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, amendi ng 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, 30.12.2006, p. 1). EN 11   EN Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER