EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
amending, for the purposes of adapting to technical progress, Annex IV to Directive 
2011/65/EU of the European Parliament and of  the Council as regards an exemption for 
lead in solders of electrical connections to temperature measurement sensors in certain 
devices 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Subject: Commission Delegated Directive amending, for the purposes of ad apting to technical 
progress, Annex IV of the Directive 2011/65/EU  of the European Parliament and of the 
Council as regards an exemption fo r applications containing lead. 
Directive 2011/65/EU of the European Parl iament and of the C ouncil of 8 June 2011 
(RoHS 2)1 restricts the use of certain hazardous substances in electrical and electronic 
equipment. RoHS 2 (recast) entered into force on 21 July 2011. 
The restricted substances are list ed in Annex II of RoHS 2; wh ile to date the restriction of 
lead, mercury, cadmium, hexavalent chro mium, polybrominated biphenyls, and 
polybrominated diphenyl ethers restriction is being enforced, the restriction of 
bis(2-ethylhexyl) phthalate (DEH P), butyl benzyl phthalate (BBP ), dibutyl phthalate (DBP), 
diisobutyl phthalate (DIBP) shall be enfor ced from 22 July 2019. Annexes III and IV of 
RoHS 2 list the materials and components of Electrical and Electroni c Equipment (EEE) for 
specific applications exempted from the subs tance restriction in RoHS 2 Article 4(1). 
Article 5 of RoHS contains the provisions fo r the adaptation to scientific and technical 
progress (inclusion and deletion of exemptions) of Annexes III and IV. Pursuant to Article 
5(1)a, exemptions shall be included in Annexe s III and IV, provided that such inclusion does 
not weaken the environmental and health protection afforded by Regulation (EC) 
No 1907/2006 and where any of the following cond itions is fulfilled: their elimination or 
substitution via design changes or materials a nd components which do not require any of the 
materials or substances listed in Annex II is sc ientifically 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. 
Article 5 establishes a procedure for the adaptati on of the Annexes to scientific and technical 
progress. Article 5(1) provides that the European Commission (t he Commission) shall include 
materials and components of EEE fo r specific applicati ons in the lists in Annexes III and IV 
by means of individual delegated acts  in accordance with RoHS 2 Article 20. 
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
As a consequence of the provisions in Article  5(3) and Annex V for granting, renewing or 
revoking an exemption, which allo ws stakeholders to apply for an exemption from the 
substance restriction, the Commission has re ceived about 50 requests for new exemptions 
since the publication of RoHS  2 and about 100 requests to renew existing exemptions. 
The Commission received an applic ation on the 23 May 2014 in relati on to the use of lead in 
solders used to make electrical connections to  temperature measurement sensors designed to 
be used periodically at temperature below -150° C. In Annex IV to RoHS 2, the exemption 26 
covers the use of lead in so lders for certain EEE applications  that are used durably at a 
temperature below -20°C under normal operati ng and storage conditions. Exemption 26 in 
RoHS Annex IV therefore does not cover the us e of lead in sensors in devices that are 
operated only temporarily below -20°C. 
With a view to evaluate the application fo r exemption, the Commission commissioned a study 
and carried out the requisite technical and scientific assessment including an official 8-week 
                                                 
1 OJ L 174, 1.7.2011, p. 88.  
EN 3   EN online public stakeholder consultation2 for the application3. One document was submitted 
during the stakeholder consulta tion by the Japanese Business Council in Europe suggesting a 
possible relation with exemption 7a in RoHS An nex III to the requeste d exemption; this was 
considered not applicable since exemption 7a in RoHS Annex II I allows the use of lead in 
high melting point solders with a lead content of at least 85%, while the application concerned requests an use of solder s with only 37% of lead. 
The final report for the application assessment was written by consultants Oeko Institute, 
approved by DG Environment and published
4; stakeholders and Member  States were notified. 
The project page is accessibl e via the DG Environment webpage5. 
Subsequently, the Commission consulted the o fficial expert group fo r delegated acts under 
RoHS 2. A proposed modification of the RoHS 2 Annex IV with all necessary background 
information was sent out on 9 September 2015 a nd experts were invited to comment on the 
proposal by 8 October 2015. The expert group unanimously supported the proposal to the 
amendment of the exemption 26 in Annex IV with the inclusion th erein of solders of electrical 
connections to temperature measurement sensor s in devices which are designed to be used 
periodically at temperatures below –150°C un til 30 June 2021. All necessary steps pursuant to 
Article 5(3) to (7) have been performed. Council and Parliament were notified of all activities. 
According to the final report, the following technical information was collected (for further 
information see footnote 4): 
• Lead is present in cryogenic sensors, which are used in a wide va riety of applications 
in EEE. These sensors measure very low te mperatures; while in some applications 
the sensor remains at very low temperatur es for many years, in other applications, 
temperature will rise and fall so that sens ors are at low temperature for many shorter 
periods. Lead is used for electrical connect ions to cryogenic sens ors to prevent the 
formation of thick intermetallic phases, whiskers, and tin pest. 
• Lead-free solders cannot be us ed in cryogenic applications, as they are prone to tin 
pest, which seriously affects the reliability of the appliances. It has been proven that, 
in typically-operated cryogenic sensors, no alternative connection technologies other 
than soldering are both reliable and available. 
• Though other soldering or conn ection technologies  exist, they ca nnot reliably 
substitute lead solders in the external cont acts of temperature sensors that are used 
periodically at temperatures below –150°C. 
• Technically and scientifically, the justifi cation of the exemption request is very 
similar to the rationale unde rpinning exemption 26 of Annex IV to RoHS 2 whose 
key technical constraint is the tin pest phenomenon occurring at low temperatures. 
With respect to the amendment of the exemption 26 in Annex IV with th e inclusion therein of 
"solders of electrical connections to temperat ure measurement sensors in devices which are 
                                                 
2 http://ec.europa.eu/environment/consultations/rohs12_en.htm ; consultation period from 31.10.2014 to 
09.01.2015 
3 The list of consulted stakeholders is regularly upda ted and maintained by the consultants in cooperation 
with the Commission, and includes electronics related industry organisations, manufacturers and 
suppliers, recyclers, consumer associations, NGOs , academia, Member States' representatives, etc. 
4 Direct link to evaluation and recommendation:  https://circabc.europa.eu/sd/a/dc3ec089-8ce1-4592-
93d7-12e7fbbefc44/20150624_RoHS_Ex_Pack6_Final_Report.pdf , 
http://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/20150624_RoHS_Ex_Pack6_Final_Rep
ort.pdf . 
5 http://ec.europa.eu/envi ronment/waste/rohs_eee/ studies_rohs1_en.htm .  
EN 4   EN designed to be used periodicall y at temperatures below –150°C ", the evaluation results show 
that at least one of the relevant criteria specified in Article 5(1)(a) is fulfille d and the inclusion 
of the specific application in the exemptions listed in Annex IV is thus justified. The technical reasons are similar to those justifying the exemption 26 of Annex IV expiring on 30 June 
2021. Thus, the same expiry date for this reques ted exemption should be granted, so that in 
future potential renewal applications shall be assessed at once. This period is unlikely to have adverse impacts on innovation as no alternative are available today or are likely to come to 
market in the same period. The specific exemption does not weaken the 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 proposed act grants an exemption from the substance restrictions of Directive 
2011/65/EU (RoHS 2), to be listed in Annex IV, fo r the use of lead in specific applications. 
The proposed instrument is a delegated dir ective, which implements Directive 2011/65/EU, 
and in particular Arti cle 5(1)(a) thereof. 
The objective of the proposed act is to ensu re legal certainty and sustainable market 
conditions for electronic  manufacturers, by allowing specific applications of otherwise banned 
substances in line with the provisions of RoHS 2 and the therein established procedure for the 
adaptation of the Annexes 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 proposal has no implications for the EU budget.  
EN 5   EN COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
amending, for the purposes of adapting to technical progress, Annex IV to Directive 
2011/65/EU of the European Parliament and of  the Council as regards an exemption for 
lead in solders of electrical connections to temperature measurement sensors in certain 
devices 
(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 certain hazardous substances in electrical and 
electronic equipment
6, and in particular Article 5(1)(a) thereof, 
Whereas: (1) Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment 
placed on the market.  
(2) Lead is used for electrical connections in  cryogenic sensors for medical devices and 
monitoring and control instruments to prev ent the formation of thick intermetallic 
phases, whiskers, and tin pest. Those sensors are used in so me applications to measure 
very low temperatures for short periods. 
(3) Lead-free solders cannot be used in cryogeni c applications, as they are prone to tin 
pest, which seriously affects the reliability of the appliances. It has been proven that, 
in typically operated cryogenic sensors, no alternative connection technologies other 
than soldering are both reliable and available. 
(4) Lead solders in the external contacts of temperature sensor s that are used periodically 
at temperatures below –150°C should therefore be exempted until 30 June 2021, as the exemption in point 26 of Annex IV to  Directive 2011/65/EU . In view of the 
innovation cycles for medical devices an d monitoring and control instruments, 
duration of this exemption is unlikel y to have adverse impacts on innovation. 
(5) Directive 2011/65/EU should therefore be amended accordingly, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex IV to Directive 2011/65/EU is amended as  set out in the Annex to this Directive. 
                                                
 
6 OJ L 174, 1.7.2011, p. 88.   
EN 6   EN Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by [ OP, please insert, as concrete 
date, the last day of the 9th month after entry into force of this directive ] at the latest. 
They shall forthwith communicate to the Co mmission 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 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. 
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  […]