EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2018) 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)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
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 electronic 
equipment  (recast)1 (RoHS  2) as regards an exemption for specific applicati ons 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 restriction s of bis(2 -ethylhexyl) phthalate (DEHP), 
butyl benzyl phthalate (BBP), dibutyl phthalate (DB P), 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 electronic 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 following conditions is fulfilled: their 
elimination or substitution via design changes or materials and comp onents which do not 
require any of the materials or substances listed in Annex II is scientifically or technically 
impracticable; the reliability of substitutes 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 European 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 procedure 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 applic ation 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 
telecommunications 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.  Moreover, the Commission 
received in January 2015 a request no. 2015 -3 for a new exemption to be added to Annex IV 
for discharge lamps when used as phototherapy lamp s containing phosphors. As the 
assessment showed that it is mechanically possible that a lamp intended for medical use can 
fit in tanning equipment  and vice versa , it was decided to merge these exemption requests 
under the assessment of exemption 18(b).  
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. In 
accor dance with the Better Regulation Guidelines, the draft Delegated Directive was 
published on the Better Regulation Portal for a four -week public feedback period. Two 
comments were received, both addressing the issue of categories  applicable to the wording o f 
the draft Delegated Directive. The comments were taken into account  and the draft  Delegated 
Directive was correspondingly  amended . All necessary steps relating to exemptions from the 
substance restriction pursuant to Article s 5(3) to 5(7) have been perfo rmed .7 The Council and 
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 medical applications . It 
provides UV intensi ty 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 criteria  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 the specific exemption is consistent 
with Regulati on (EC) No  1907/2006 (REACH)  and thus does  not weaken the environmental 
and health protection afforded by it, in accordance with Article 5 of Directive 2011/65/EU.  
Furthermore, at least one of the relevant criteria specified in Article 5(1)(a) is met by th e 
                                                                                                                                                         
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 -restrictions -in-electrical -and-
electronic -equipment -pbKH0416554/   
7 A list of  the required administrative  steps is available on the Commission website . Current stage of the 
procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts 
at https://webgate.ec.europa.eu/regdel/#/home .  
EN 4  EN 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 have adverse impacts on 
innovation . Furthermore, in view of reques t no. 2015 -3 and the fact that  it is mechanically 
possible that a lamp intended for medical or tanning use can fit in the same l uminaire or 
equipment, a new sub -entry to the exemption 18(b) specific  to medical applications (except 
those covered under point  34 of Annex IV)  shall be added .  
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) .  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Delegated Directive grants an exemption fr om 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 functioning of the internal market in 
the f ield 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 procedure for the adaptation of the Annexe s 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 Treaty 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 equipment1 and in particular 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 certain hazardous substances  listed 
in Annex II to that Directive.  That requirement does not apply to the applications 
listed in Annex III to Directive 2011/65 /EU. 
(2) The different categories of electrical and electronic equipment for which Directive 
2011/65/EU applies are listed in Annex I to that Directive.  
(3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The use of 
lead as activ ator 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) was, however, exempted from the restriction and is as such  currently 
listed in entry 18(b)  of Annex I II to that Directive. The original  expiry date of that 
exemption was, for categories 1 to 7 and 10, 21 July 2016 , in accordance with the 
second subparagraph of Article 5(2) of that Directive .  
(4) The Commission received an application for renewal of th at exemption before 
21 January  2015, in accordance with the first subparagraph of Article 5(5) of Directive 
2011/65/EU.  That exemption remains  valid until a decision on th at application has 
been adopted, in accordance with the second subparagraph of that Art icle. 
(5) Moreover, the Commission received in January 2015 a request no. 2015 -3 for a new 
exemption to be added to Annex IV for discharge lamps when used as phototherapy 
lamps  (medical equipment)  containing phosphors. As the assessment showed that it is 
mechanically possible that a lamp intended for medical use can fit in tanning 
equipment and vice versa, it was decided to merge these exemption requests under the 
assessment of exemption under entry 18(b)  in Annex III . 
(6) 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 -
                                                 
1 OJ L 174, 1.7.2011, p. 88.   
EN 6  EN 400nm) radiation and it  is used in over 95%  of the indoor low pressure mercury 
vapour fluorescent lamps in tanning and certa in medical applications . It provides UV 
intensity at the wavelength of 350 nm that is crucial in order to initiate  skin 
pigmentation.  
(7) 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 alternatives available.  
(8) Due to the lack of reliable substitutes, a  substitution or elimination of lead  is still 
scientifically and technically impracticable  for cert ain discharge lamps containing 
phosphors . The exemption is consistent with Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council2 and thus  does not weaken the environmental 
and health protection afforded by  it. The exemption for 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 should therefore be renewed .  
(9) Since, for the applications concerned, no reliable alternatives are yet available on the 
market, the exemption for categories 1 to 7 and 10 of Annex I to Directive 
2011/65/EU should be renewed for the maximum  validity period  of five years until 21 
July 2021. In view of the results of the ongoing efforts to find a reliable substitution , 
the duration of th e exemption is unlikely to have adverse impacts on innovation . 
(10) For categories other than 1 to 7 and 10  of Annex I to Directive 2011/65/EU , the 
existing exemption remains valid as per the validity periods set out in the second 
subparagraph of Article 5(2) of Directive 2011/65/EU . For reasons of legal  clarity , the 
dates of expiry should be specified  in Annex III to that Directive.  
(11) In view of request no. 2015 -3 and the fact that  it is mechanically possible for a lamp 
intended for medical use to fit in tanning equipment and vice versa, a new sub -entry 
18(b) -I should be added in Annex III to Directive 2011/65/EU specific to medical 
applications with the except ion of  those covered by entry  34 of Annex IV to Directi ve 
2011/65/EU . This sub -entry should apply to categories 5 and 8 and be  valid until 21 
July 2021 . 
(12) 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 t o comply with this Directive. They shall 
forthwith communicate to the Commission the text of those provisions.  
                                                 
2 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) and 
establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).   
EN 7  EN 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 com municate to the Commission the text of 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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