EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
  
COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes of adapting to scientific and technical progress, Annex III to 
Directive  2011/65/EU of the European Parliament and of the Council as regards an 
exemption for lead as activator in the fluorescent powder of discharge lamps containi ng 
phosphors  
(Text with EEA relevance)    
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
This Commission Delegated Directive amends, for the purpose of adapting to technical 
progress, Annex I II of Directive 2011/65/EU of the European Parliament and of the Council 
on the restriction of the use of certain hazardous substances in electrical and e lectronic 
equipment  (recast)1 (RoHS  2) as regards an exemption for specific applications containing 
lead. 
RoHS  2 restricts the use of certain hazardous substances in electrical and electronic 
equipment , as provided for in its Article 4 . It entered into force on 21 July 2011.  
The restricted substances are listed in Annex II to RoHS  2. While the restriction s of lead, 
mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated 
diphenyl ethers are in force to date, the r estriction s of bis(2 -ethylhexyl) phthalate (DEHP), 
butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall 
apply  from 22 July 2019  or later . Annexes III and IV to RoHS 2 list the materials and 
components of electrical and e lectronic equipment (EEE) for specific applications exempted 
from the substance restriction of RoHS  2 Article 4(1).  
Article 5 makes provision for the adaptation to scientific and technical progress (inclusion,  
renewal, amendments and revoking  of exemptions ) of Annexes III and IV. Pursuant to 
Article  5(1)(a), exemptions are to be included in Annexes III and IV  only if  such inclusion 
does not weaken the environmental and health protection afforded by 
Regulation  (EC)  No 1907/20062 and where any of the followi ng conditions is fulfilled: their 
elimination or substitution via design changes or materials and components which do not 
require any of the materials or substances listed in Annex II is scientifically or technically 
impracticable; the reliability of subst itutes is not ensured; or the total negative environmental, 
health and consumer safety impacts caused by substitution are likely to outweigh the total 
environmental, health and consumer safety benefits thereof.  
Furthermore, Article 5(1) provides that the E uropean Commission (the Commission) shall 
include materials and components of EEE for specific appli cations in the lists in Annexes  III 
and IV by means of individual delegated acts in accordance with Article  20. Article 5(3) and 
Annex V establish the proce dure for submitting applications for granting, renewing, or 
revoking an exemption.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Since the publication of RoHS 2 , the Commission has received numerous3 requests from 
economic operators, according to the provisi ons in Article 5(3) and Annex V, for both 
granting new and renewing existing exemptions.  
The current  Annex III exemption 18(b) permits the use of lead as activator in the fluorescent 
powder (1% lead by weight or less) of discharge lamps when used as  sun tanning lamps 
containing phosphors such as BSP (BaSi2O5: Pb). The Commission received two application s 
for renewal of this exemption in December  2014 and January  2015 . While e xemption 18(b) 
had 21 July 2016  as expir ation date  for categories 1 to 7 and 104, in line with the requirements 
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 OJ L 396, 30.12.2006, p. 1 
3 The l ist is given at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm  
4 These categories are namely: 1. Large household appliances; 2. Small household appliances; 3. IT and 
telecommu nications equipment; 4. Consumer equipment; 5. Lighting equipment; 6. Electrical and  
EN 3   EN of the RoHS Directive  (Article 5(5), second subparagraph ), it continues to apply until a 
decision on the renewal application is taken by the  Commission.  
With a view to evaluat ing the application  for exemption , the Commission launched a study to 
carry out the required technical and scientific assessment,  including an eight -week online 
open -ended stakeholder consultation5 on the application. One contribution w as made to the 
stakeholder consultation.  
The final report containing the assessment of the application was published6; stakeholders 
were notified.  
Subsequently, the Commission consulted the Member States expert group for delegated acts 
under RoHS 2  during an expert meeting on 15 December 2016, which also involved  
presentations from the applicants and stakeholders most concerned.  The experts agreed with 
the draft presented by the Commission, with a large majority of absent or silent members. All 
necessary steps relating to exemptions from the substance restriction pursuant to Article s 5(3) 
to 5(7) have been performed. Due to the large amount of simultaneous exemption requests 
and connected administrative requirements, the Commission decision procedure followed 
alternative deadlines as per Article 5(5). The Council a nd the European Parliament were 
notified of all activities.  
The final report  highlighted in particular the following technical information and assessment : 
 Lead activator  in the fluorescent powder  is required to allow the barium silicate 
phosphor to fluoresce. It transforms the 254 nm radiation to the desi gned UV 
(290nm -400nm) radiation and it  is used in over 95%  of the indoor low pressure 
mercury vapour fluorescent lamps in tanning and certain med ical applications . It 
provides UV intensity at the wavelength of 350 nm that is crucial in order to initiate  
skin pigmentation (tanning result).  
 Tanning equipment is strictly regulated in the EU and any possible alternative to lead 
would have to fulfil cri teria on reliability, safety and health r isk concerns . Currently, 
there are no such alternatives available and the substitution of lead hence is 
scientifically and technically impracticable.  
The evaluation results for categor y 1 to 7 and 10 show that at l east one of the relevant criteria 
specified in Article 5(1)(a) is met by the exemption request relating to entry 18(b) in Annex 
III. Since for the applications concerned, no sufficiently reliable alternatives are available 
today or are likely to come on the market soon , validity period until 21 July 2021  is justified ; 
as reliable substitutes are not yet available, no negative socioeconomic impacts of substitution 
are to be anticipated for this period. The granted validity period is also not expected to h ave 
adverse impacts on innovation  Furthermore, since it is mechanically possible that a lamp 
intended for medical or tanning use can fit in the same l uminaire or equipment, the exemption 
shall apply  also to medical applications (except those covered under point 34 of Annex IV). 
As the exemption grants lead use in the fluorescent powders of discharge lamps, the category 
concerned is category 5.  
For categories other than categories 1 to 7 and 10, the existing exemption remains as per the 
validity periods set out in Article 5(2) . The specific exemption does not weaken the 
                                                                                                                                                         
electronic tools; 7. Toys, leisure and sports equipment; 10. Automatic dispensers. EEE categories are 
listed in Annex I to the RoHS  Directive . 
5 Consultation period : from 21.08.2015 to 16.10.2015  
6 https://bookshop.europa.eu/en/assistance -to-the-commission -on-technological -socio -economic -and-
cost-benefit -assessment -related -to-exemptions -from -the-substance -restrict ions-in-electrical -and-
electronic -equipment -pbKH0416554/    
EN 4   EN environmental and health protection afforded by Regulation (EC) No  1907/2006 (REACH), in 
accordance with Article 5 of Directive 2011/65/EU.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Delegated  Directive grants an exemption from the restri ctions in Article 4(1), to be listed 
in Annex III  of Directive  2011/65/EU , for the use of lead in specific applications.  
The inst rument is a Delegated Directive , as provided for by Directive 2011/65/EU, and in 
particular meeting the relevant requirements of Article 5(1)(a) thereof.  
The objective of the Delegated Directive  is to contribute to the protection of human health and 
the environment and approximate the provisions for the fun ctioning of the internal market in 
the field of electrical and electronic equipment , by allowing the use of otherwise banned 
substances for specific applications, in line with the provisions and under the conditions of 
RoHS  2 and the therein established pr ocedure for the adaptation of the Annexes  III and IV  to 
scientific and technical progress.  
In accordance with the principle of proportionality, the measure does not go beyond what is 
necessary to achieve its objective.  
The proposal has no implications for the EU budget.  
  
EN 5   EN COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes of adapting to scientific and technical progress, Annex III to 
Directive  2011/65/EU of the European Parliament and of the Council as regards an 
exemption for lead as activator in the fluorescent powder of discharge lamps containing 
phosphors  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Tr eaty on the Functioning of the European Union,  
Having regard to Directive 2011/65/EU of the European Par liament and of the Council of 
8 June 2011 on the restriction of the use of certain hazardous substances in electrical and 
electronic equipment7 and in p articular Article 5(1)(a) thereof , 
Whereas:  
(1) Directive 2011/65/EU requires Member States to ensure that electrical and electronic 
equipment placed on the market does not contain lead. 
(2) Point 18(b) of Annex III to Directive 2011/65/EU exempted the use  of lead as 
activator in the fluorescent powder (1% lead by weight or less) of discharge lamps 
when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5: Pb) 
until 21 July 2016 . The Commission received an application for renewal of this 
exemption in relation to categories 1 to 7 and 10 before 21 January  2015 , in 
accordance with Article 5(5) of Directive 2011/65/EU . 
(3) Lead activator  in the fluorescent powder  is required to allow the barium silicate 
phosphor to fluoresce. It transfor ms the 254 nm radiation to the desi gned UV (290nm -
400nm) radiation and it  is used in over 95%  of the indoor low pressure mercury 
vapour fluorescent lamps in tanning and certain medical applications . It provides UV 
intensity at the wavelength of 350 nm that is crucial in order to initiate  skin 
pigmentation.  
(4) Tanning equipment is strictly regulated in the Union and any possible alternative to 
lead would have to fulfil criteria  on reliability, safety and health risk concerns. 
Currently, there are no such al ternatives available and the substitution of lead is 
therefore scientifically and technically impracticable.  
(5) Furthermore, since it is mechanically possible that a lamp intended for medical or 
tanning use can fit in the same luminaire or equipment, the exemption applies also to 
medical applications except those covered under point 34 of Annex IV  to Directive 
2011/ 65/EU . 
(6) Since for the applications concerned  in categories 1 to 7 and 10  no sufficiently reliable 
alternatives are available on the market  or are likely to be available on the market in 
the near future , validity period until 21 July 2021 is justified . As the exemption grants 
                                                 
7 OJ L 174, 1.7.2011, p. 88.   
EN 6   EN lead use in the fluorescent powders of discharge lamps, the exemption shall be limited 
to category 5. For categories other than categories 1 to 7 and 10, the existing 
exemption is valid  as per the validity periods set out in  the seco nd subparagraph of  
Article 5(2) of Directive 2011/65/EU . 
(7) Directive 2011/65/EU should therefore be amended accordingly,   
 
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.  
Article 2 
1. Member States shall adopt and publish, by [the last day of the  12th month after the 
date of entry into force of this directive ] at the latest, the laws, regulations and 
administrative provisions necessary to comply with this Directive. They sh all 
forthwith communicate to the Commission the text of those provisions.  
They shall apply those provisions from [the last day of the  12th month after the date 
of entry into force of this directive  + 1 day ]. 
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 o f the main provisions 
of national law which they adopt in the field covered by this Directive.  
Article 3 
This Directive shall enter into force on the twentieth 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  
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