EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) 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 the use of mercury in High Pressure Sodium (vapour) lamps with 
improved  colour rendering index for general lighting purposes  
 
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
This Commission Delegated Directive amends, for the purpose of adapting to technical and 
scientific progress, Annex III to 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 (the Ro HS Directive) . The amendment concerns an exemption 
for specified applications containing mercury in high pressure sodium lamps with improved 
colour rendering index for general lighting purposes . 
The RoHS Directive restricts the use of certain hazardous sub stances in electrical and 
electronic equipment (EEE), as specified in Article 4. Ten substances are currently restricted 
and listed in Annex II to the RoHS Directive: lead, mercury, cadmium, hexavalent chromium, 
polybrominated biphenyls (PBB), polybrominat ed diphenyl ethers (PBDE), bis (2 -ethylhexyl) 
phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl 
phthalate (DIBP). Annexes III and IV list the EEE materials and components for specific 
applications that are exempt from t he substance restrictions laid down in Article 4(1).  
Article 5 of the Directive provides for the adaptation of  Annexes III and IV  to scientific and 
technical progress , which can include granting, renewing or revoking the exemptions. 
Pursuant to Article  5(1)(a), exemptions are to be included in Annexes III and IV only if this 
does not weaken the environmental and health protection afforded by 
Regulation  (EC)  No 1907/2006 (REACH)2 and only if they meet any of the following 
conditions: (i) eliminati on or substituting the substance 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; (ii) the reliability of substitutes is not ensured; ( iii) 
the total negative environmental, health and consumer safety impacts caused by substituting 
the substance are likely to outweigh the total environmental, health and consumer safety 
benefits thereof.  
Decisions on exemptions, and their duration, must al so take into account the availability of 
substitutes and the socioeconomic impact of substitution. Decisions on the duration of 
exemptions must take into account any potential impact on innovation. Life -cycle thinking on 
the overall impacts of the exemptio n must be applied , where relevant.  
Article 5(1) also s pecifies that, to include or delete materials and components of EEE for 
specific applications listed in Annexes  III and IV , the Commission must adopt  individual 
delegated acts. Article 5(3) and Annex V  describe the procedure for submitting exemption -
related applications.   
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission receive s requests3 from economic operators to grant or renew exemptions 
under Article 5(3) and Annex V to the RoHS Directive.  
The current Annex III exem ption 4 (b) entries I to III permit the use of mercury in High 
Pressure Sodium (HPS) (vapour) lamps for general lighting purposes not exceeding the 
following values (per burner) in lamps with improved colour renderi ng in dex Ra > 60:  
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 OJ L 396, 30.12.2006, p. 1. 
3 The list is available at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm . EN 2  EN 4(b) – I: P ≤ 155  W: 30  mg;  
4(b) – II: 155  W < P ≤ 405  W: 40  mg;  
4(b) – III: P > 405  W: 40  mg. 
The Commission received one application  to renew the exemption 4 (b) entries I to III in 
January 2015 . The applicant  claim ed, in essence , that there were no mercury -free alternatives  
providing the same colour specification that could replace the lamps covered by exemption 
4(b).4 In January 2020, the same applicant submitted a n updated  renewal  application for the 
lamps with colour rendering >80 (not above 60 as in current exemption), below 105W (not 
155W as in current exemption) and with a limited amount of mercury only 16 mg (instead of 
the currently allowed 30 mg) . In line with the requirements of th e RoHS Directive (Article 
5(5), second subparagraph ), an exemption remains valid until the Commission takes  a 
decision on the renewal application.  
To evaluat e the applications for renewing that exemption, the Commission launched a study 
in June 20155, concluded in 2016, to carry out the required technical and scientific 
assessment, including an eight -week online stakeholder consultation.6 Further to that study 
assessing the extensive technical and scientific data and contributions received, as 
documented in the study report, the Commission carried  out two complementary 
studies/updates, including stakeholder involvement. The study published in 20197 focused on 
the socioeconomic assessment and availability of substitutes, whilst an update based on recent 
figures and modelling was carried out in 20208. The final reports of the study and of the 
socioeconomic assessment updates were published9; stakeholders were notified.  
The Commission consulted the Member State expert group for delegated acts under the RoHS 
Directive during the expert meetings of  1 September  2016, 29  October  2018 and 
21 October  2019 to collect  Member States’ views on an envisaged course of action in line 
with the conclusions of the evaluations. It carried out a ll the requisite procedural steps relating 
to exemptions from the substanc e restriction under Article 5(3) to 5(7).10 The Council and the 
European Parliament were notified of all activities.  
The evaluation studies, corroborated  with the updated information on technical and scientific 
progress provided by the applicant in 2020,  leads to the following conclusion s: 
 mercury cannot be substituted in HPS  (vapour) lamps with colour rendering index 
>80, below 105W and with mercury limit of 16 mg which effectively means that 
exemption 4 (b) should  be partly renewed as alternatives do not currently provide the 
relevant red part of the spectrum that is essential for this type of lamps ; 
                                                 
4 http://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_9/  
Exemption_4_b__IIII_/4b_LE_RoHS_Exemption_Req_Final.pdf . 
5 The f inal report of the study is available at https://op.europa.eu/en/publication -detail/ -/publication/a3fdcc8c -
4273 -11e6 -af30-01aa75ed71a1 . 
6 Consultation period: 21 August 2015 to 16 October 2 015, http://rohs.exemptions.oeko.info . 
7 https://rohs.exemptions.oeko.info/fileadmin/use r_upload/reports/FWCW_RoHS_Lamps_  
SEA_20190729_Final.pdf  
8 https://op.europa.eu/en/publication -detail/ -/publication/f44f2383 -dd0a -11ea -adf7-01aa75ed71a1/language -
en/format -PDF/source -146144383 , starting on page 92.  
9 https://ec.europa.eu/environment/waste/rohs_eee/studies_rohs1_en.htm .  
10 A list of the required administrative steps is available on the Commission website . The c urrent 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 3  EN  there are suitable alternatives for HPS (vapour) lamps  with improved colour 
rendering index Ra > 60: P ≤ 155  W which effectively means that exemptions  entry  4 
(b) – I is partly no longer needed, while entry 4 (b) – II can be fully revoked as those 
lamps were being replaced by mercury -free LED lamps.  
 entry 4 (b)-III should be revoked as manufacturers no longer place these  lamps on the 
market; hence the exemption  has become obsolete . 
In conclusion, the scientific and technical assessments , including updated information 
provided by the applicant , detailed that the exemption criteria continue to be met with regard 
to the exemption for the use of mercury in HPS (vapo ur) lamps with colour rendering index > 
80 and with a mercury limit use of 16  g per lamp, as substitutes require further develop ment .  
The evaluation results also show ed that renewing the specific exemption would not weaken 
the environmental and health protection afforded by the REACH Regulation, in accordance 
with Article 5 of Directive 2011/65/EU.   
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delegated directive partially  renews and reformulates exemption entry 4 (b)-I listed in 
Annex III to Directive  2011/65/EU for the use of mercury in High Pressure Sodium (vapour) 
lamps for general lighting purposes not exceeding (per burner) in lamps with improved colour 
rendering index  Ra > 80: P ≤ 105 W: 16 mg . Given that the other entries listed under entry 
4(b) are to be revoked, the part of entry 4(b) -I that is to be renewed  is renumbered as entry 
4(b).  
The Commission’s assessment based on the supporting studies , consultations  and updated 
information submitted by the applicant  concluded that the exemption request meets at least 
one of the criteria laid down in Article 5(1)(a): the substitution of mercury, with reliable 
substitutes, in the lamp categories concerned by this exemp tion cannot currently be ensured.  
In light of the above, exemption entries 4 (b)-II and 4(b)-III are to be revoked , and exemption 
4(b)-I is to be partially revoked.  
As concluded by the evaluation, the state of development of substitutes justifies partially 
renewing exemption entry 4(b) -I, as reworded , which is renumbered to exemption entry 4(b),  
for the maximum validity period of five years. The validity period is not expected to have  an 
adverse impact on innovation.  
For the part of entry 4 (b) -I that is to be revoked, as well as for entries  4(b)-II and 4(b)-III, the 
shortest expiry dates (i.e. 12 months) are appropriate in line with Article 5(6) of the RoHS 
Directive.  
The legal instrument is a delegated directive, as provided for by Directive 201 1/65/EU, in 
particular with the requirements set out in Article 5(1)(a) thereof.  
The objective of the delegated directive is to contribute to the protection of human health and 
the environment and to align the provisions for the functioning of the internal  market in the 
field of electrical and electronic equipment, by allowing the use of otherwise banned 
substances for specific applications, with the provisions and under the conditions of the RoHS 
and the procedure for adapt ing Annexes III and IV to scienti fic and technical progress.  
The delegated directive has no implications o n the EU budget.  EN 4  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 the use of mercury in High Pressure Sodium (vapour) lamps with 
improved colour rendering index for general lighting purposes  
 
(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 Parliament and of the Council of 
8 June 2011 on the restriction of the use of certa in hazardous substances in electrical and 
electronic equipment1, and in particular Article 5(1 ), point s (a) and (b) thereof,  
Whereas:  
(1) Directive 2011/65/EU requires Member States to ensure that electrical and electronic 
equipment placed on the market does not contain the hazardous substances listed in 
Annex II to that Directive. That restriction does not apply to certain exempted 
applications listed in Annex III to that Directive.  
(2) The categories of electrical and electronic equipment to which Directive 2011 /65/EU 
applies are listed in Annex I to that Directive.  
(3) Mercury is a restricted substance listed in Annex II to Directive 2011/65/EU.   
(4) By Decision 2010/571/EU2, the Commission granted, among other things , an 
exemption for the use of mercury in High Pressur e Sodium (vapour) lamps for general 
lighting purposes not exceeding (per burner) in lamps with improved colour rendering 
index Ra > 60  (‘the exemption’) , which is now listed as  exemption 4(b)-I, 4(b) -II and 
4(b)-III in Annex III to Directive 2011/65/EU . The exemption was to expire on 21 
July 2016, in accordance with Article 5(2), second subparagraph, point (a), of that 
Directive . 
(5) Mercury is used in High Pressure Sodium (vapour) lamps for light colour and colour 
rendering properties.  
(6) In January 2015, t he Commission received an application for renewal of the 
exemption for applications in entries 4(b)-I, 4(b) -II and 4(b) -III (‘the renewal 
application’ ), that is within the time limit laid down in Article 5(5) of Directive 
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
2 Commission Decision 2010/571/EU of 24  September 2010 amending, for the purposes of adapting to 
scientific and technical progress, the Annex to Directive 2002/95/EC of the European Parliament and of 
the Council as regards exemptions for applications containi ng lead, mercury, cadmium, hexavalent 
chromium, polybrominated biphenyls or polybrominated diphenyl ethers (OJ L 251, 25.9.2010, p. 28).  EN 5  EN 2011/65/EU . In January 2020, the same  applicant submitted a n updated  renewal 
application  concerning entry 4 (b)-I only.  In accordance with Article 5(5)  of Directive 
2011/65/EU, the exemption remains valid until a decision on the renewal application 
has been taken . 
(7) The evaluation of the renewal  application , which took into account the availability of 
substitutes and the socioeconomic impact of substitution, concluded that the  
substitution or elimination of mercury in the applications concerned was scientifically 
and technically practicable as concerns a part of entry 4(b)-I, as well as entries  4(b)-II 
and 4(b) -III of Annex III to Directive 2011/65/EU. The evaluation concluded 
nevertheless that the exemption should be renewed for  the part of entry 4 (b)-I which 
concerns  lamps with a high colour rendering higher than 80 , equal to or lower than 
105W and that, whilst the use of mercury is still necessary, that can be further 
lowered. The evaluation included stakeholder consultations in accordance with Ar ticle 
5(7) of Directive 2011/65/EU. The comments received during those consultations 
were made publicly available on a dedicated website.  
(8) It is therefore appropriate to renew part of exemption  4(b)-I, and renumber it  as 
exemption entry 4(b) , for a maximum period of five years in accordance with Article 
5(2), first subparagraph, of Directive 2011/65/EU. This renewed exemption   shall have 
a revised wording  setting  out the further limited  scope of the exemption . In view of the 
results of the ongoing efforts to  find a reliable substitution ,                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
the duration of the exemption is unlikely to have adverse impacts on innovation .  
(9) The renewed exemption is consistent with Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council3 and thus  does not weaken the environmental 
and health protection afforded by it.  
(10) As the conditions for the renewal of the exemption , set out in Article 5(1), point (a) , of 
Directive 2011/65/EU , are no longer fulfilled  for the applications listed in the 
remainder of entry  4(b)-I as well as in entries  4(b)-II and 4(b) -III of Annex III to that 
Directive , the exemption for those applications should be revok ed. Expiry dates for 
those exemption s should be set in accordance with Article 5(6) of Directive 
2011/65/EU.  
(11) 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 sixth month after the 
date of entry into force of this Directive]  at the latest, the laws, regulations and 
                                                 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registr ation, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency , amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC  (OJ L 396, 30.12.2006, p. 1).  EN 6  EN administrative provisions necessary to comply with this Directive. They shall 
forthwith communicate to the Commission the text of those provision s. 
They shall apply those provisions from [the last day of the sixth 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 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  
 Ursula VON DER LEYEN  
 The President  