EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes of adapting to scientific and technical progress, Annex IV to 
Directive 2011/65/EU of the European Parliament and of the Council as regards an 
exemption for mercury in melt pressure transducers for capillary rheometers under 
certain conditions  
(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 IV 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 ( ‘the RoHS Directi ve’)1 as regards an exemption for mercury in melt 
pressure transducers for capillary rheometers under certain conditions . 
Article  4 of the RoHS Directive restricts the use of certain hazardous substances in electrical 
and electroni c equipment. Currently, 10 substances  (or groups of substances)  are restricted 
and listed in Annex II to the Directive: lead, mercury, cadmium, hexavalent chromium, 
polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2ethylhexyl) 
phthalate (DEHP), butyl ben zyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl 
phthalate (DIBP).  
Annexes III and IV to the Directive  list the materials and components of electrical and 
electronic equipment  for specific applications exempted from the substance restrictions in  
Article  4(1). Article  5 provides for Annexes III and IV to be adapted to scientific and 
technical progress ( on granting, renewing and revoking of exemptions). Under 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 if any of the following conditions is fulfilled:  
– the elimination or substitution of the substance via design changes or use of materials 
and components th at 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;  
– the total negative environmental, health and consumer safety impacts of substitution 
are likely to outweigh the total environmental, health and consumer safety benefits.  
Decisions on exemptions, and their duration, must  take into account the availability of 
substitutes and the socio -economic 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 exemption must apply, where relevant.  
Article  5(1) provides for the Commission to include materials and components of electrical 
and el ectronic equipment  for specific applications in the lists in Annexes  III and IV by means 
of individual delegated acts pursuant to Article  20. Article  5(3) and Annex  V establish the 
procedure for submitting exemption applications.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission receives numerous requests from economic operators to grant or renew 
exemptions under Article  5(3) and Annex V to the RoHS Directive3. 
                                                 
1 OJ L 174, 1.7.2011, p.  88. 
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). 
3 The list is available at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm .  
EN 2  EN On 26 April  2021, the Commission received an application for a new entry in Annex  IV. The 
requested exemption concerns the use of  mercury in melt pressure transducers for capillary 
rheometers at temperatures over 300°C and pressures over 1000 bar . 
In October 2021, the Commission launched an  evaluati on to  carry out the required technical 
and scientific assessment. The study, which included  a ten-week public stakeholder 
consultation, finished in August  20224. Information about the consultation was provided on 
the project website5 and two stakeholder co ntribution s were  received . 
On 26 October  2022 , the Commission consulted the Member State s expert group for 
delegated acts under the RoHS  Directive . One comment was received. The Commission  
carried out all the required procedural steps relating to exemptions from the restrictions on 
substances under  Articles 5(3) to 5(7)6. In this context , the European Parliament and the 
Council were notified of all activities.  
Technical evaluation  
Mercury is used as a filling in the pressure transducer of capillary rheometer to transmit the 
pressure of the probe to a sensor outside the high temperature and pressure area.  
Capillary rheometers can analyse viscosity e.g., of melted polymers to predict  its behaviour 
e.g., for an extrusion process. The used pressure transducer consists of electrical components 
and thus, it is an electrical measurement device in the scope of the RoHS Directive. The 
capillary rheometers in question are no large -scale techn ologies that are covered by Article 
2(4)(d) of the Directive.  
In lower pressure areas mercury can be substituted. A substitution for the requested given 
range of operation over 300°C and over 1000 bar is scientifically and technically 
impracticable at the  time being.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The proposed act grant s an exemption from the substance restrictions in Annex II to Directive 
2011/65/EU, to be listed in Annex IV, for mercury in melt pressure transducers for capillary 
rheometers at te mperatures over 300°C and pressures over 1000 bar.  
Capillary rheometer can be assigned to the EEE category 9 “monitoring and control 
instruments” according to Annex I.  
The evaluation show s that the exemption to be granted would not weaken the environmenta l 
and health protection afforded by the REACH Regulation, in accordance with Article  5 of 
Directive 2011/65/EU.  
At least one of the relevant criteria specified in Article  5(1)(a) is met. The elimination or 
substitution of mercury in melt pressure transduce rs for capillary rheometers under certain 
                                                 
4 Study to assess requests for two ( -2-) exemptions, for mercury in pressure transducer and DEHP in a 
PVC base material, in Annex IV  of Directive 2011/65/EU  (Pack 25)  
https://op.europa.eu/en/publication -detail/ -/publi cation/3bc5a902 -1f69-11ed -8fa0-
01aa75ed71a1/language -en/format -PDF/source -265633428   
5 Consultation period: 30 November 2021 until 8 February 2022  
(https://rohs.e xemptions.oeko.info/exemption -consultations/2021 -consultation -2 ). 
6 A list of the required administrative steps is available on the Commission website . The 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 3  EN conditions is scientifically and technically impracticable. Therefore, the exemption is to be 
granted and an expiry date is to be set.  
The exemption was requested for seven years in accordance with Article 5(2) of the RoHS 
Directive.  
At the fourth meeting of the Conference of the Parties to the Minamata Convention on 
Mercury, the European Union proposed phase out dates for certain mercury -added products7, 
and based on this proposal, the Conference of the Parties dec ided to amend Part I of Annex A 
to the Convention8. Accordingly, electrical  and electronic measuring devices  like melt 
pressure transducers, melt pressure transmitters and melt pressure sensors have to be phased 
out (i.e., includ ing the restriction of placing on the market ) until end of 2025, except those 
installed in large -scale equipment or those used for high -precision measurement, where no 
suitable mercury -free alternative is available.  Although, there is no official definition f or 
high-precision measurement, t he use of mercury in melt pressure transducers for capillary 
rheometers at temperatures over 300°C and pressures over 1000 bar is considered not to fall 
under the exception cases, neither of large -scale nor for high -precisio n measurement.   
The restrictions under the Minamata Convention on Mercury will be transposed in Regulation 
(EU) 2017/8529. Thus, the validation period  of a possible exemption must  be limited,  and an 
expiry date of 31 December 2024 is proposed. The date by which this exemption will expire is 
set in line with Article  5(2), first subparagraph , RoHS Directive . 
It is proposed to add a new entry 49 for the relevant application in Annex I V. Since the 
capillary rheometers  described in the exemption request  fall und er category 9 “monitoring and 
control instruments”  of Annex I, the scope of the exemption should be limited to th ose. 
The legal instrument is a delegated directive, as provided for in Directive 2011/65/EU and 
meeting the relevant requirements of its Article  5(1)(a).  
The objective of the delegated directive is to  protect human health and the environment, and 
to harmonise provisions for the functioning of the single market in the field of electrical and 
electronic equipment , by allowing the use of otherwise banned substances for specific 
applications, in line with the RoHS Directive and the procedure established therein for 
adapting Annexes III and IV to the Directive to scientific and technical progress.  
The delegated directive has no implications for the EU budget.  
                                                 
7 UNEP/MC/COP.4/26/Add.1  2021  
8 UNEP/MC/COP.4/28/Add.1  2022  
9 OJ L 137, 24.5.2017, p. 1 –21.  
EN 4  EN COMMISSION DELEGATED DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes of adapting to scientific and technical progress, Annex IV to 
Directive 2011/65/EU of the European Parliament and of the Council as regards an 
exemption for mercury in melt pressure transducers for capillary rheometers under 
certain conditions  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the Europe an 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 equipment1, and in particular Article  5(1), point  (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 the hazardous substances listed in 
Annex II to that Directive. That restriction does not apply to certain  exempted 
applications  listed in Annex I V 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 Direct ive 2011/65/EU.  
(4) On 23 April  2021, the Commission received an application made in accordance with 
Article  5(3) of Directive 2011/65/EU for an exemption to be listed in Annex I V to that 
Directive, for mercury in melt pressure transducers for capillary rheome ters at 
temperatures over 300°C and pressures over 1000 bar  (‘the requested exemption’).  
(5) The used pressure transducer, incorporated in capillary rheometers, consists of 
electrical components and is an electrical measurement device in the scope of the 
Direc tive 2011/65/EU. The capillary rheometers described in the requested exemption 
fall under category 9 ‘monitoring and control instruments’  of Annex I to Directive 
2011/65/EU.   
(6) The evaluation of the exemption  application , which included a technical and scien tific 
assessment study2, concluded that substitution of mercury in melt pressure transducers 
for capillary rheometers at temperatures over 300°C and pressures over 1000 bar are 
currently  scientifically and technically impracticable . The evaluation included  
stakeholder consultations as required by Article 5(7) of Directive 2011/65/EU . 
                                                 
1 OJ L 174, 1.7.2011, p.  88. 
2 Study to assess requests for two ( -2-) exemptions, for mercury in pressure transducer and DEHP in a 
PVC base  material, in Annex IV of Directive 2011/65/EU (Pack 25)  
  
EN 5  EN (7) One of the relevant conditions  specified in Article  5(1), point (a), of Directive 
2011/65/EU is met, namely that the elimination and substitution is scientifically or 
technically impracticable.  
(8) It is, therefore, appropriate to grant the requested exemption by including the 
applications covered by it  in Annex I V to Directive 2011/65/EU  with respect to 
electrical and electronic equipment  of category 9. 
(9) In order to comply with future restrictions on mercury -added products under 
Regulation (EU) 2017/852, it is necessary to limit the validity period of the exemption  
to 31 December 2024.  The period is set in accordance with Article 5(2), firs t 
subparagraph of Directive 2011/65/EU.  
(10) 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.  
Article  2 
1. Member States shall adopt and publish, by [OP please insert the date: the last day of 
the sixth  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 shall forthwith communicate the text of those provisions to the 
Commission.  
They shall apply those provisions from [OP please insert the date: 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 Jo urnal of the European Union . 
Article  4 
This Directive is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN