legislation-obligation

Substance Regulatory Obligations

OBL

Dioxobis(stearato)trilead

EC number: 235-702-8

CAS number: 12578-12-0

Last updated: 23/02/2021
ECHA Legislation Regulatory Obligations

Regulatory obligations may exist for this substance under the legislations under ECHA’s remit or for which ECHA has delegated tasks (i.e. REACH, CLP, BPR, PIC, CAD / CMD, WFD, and POPs). Please check the substance Infocard.

Active Implantable Medical Devices Directive

Active Implantable Medical Devices Directive - Hazardous Substances

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
Dioxobis(stearato)trilead
12578-12-0
yes
Batteries Directive

Batteries Directive - Prohibitions & Labelling

This list contains use prohibitions of mercury and cadmium above certain thresholds in batteries and accumulators, with certain exceptions. It also captures certain labelling requirements on such products containing mercury, cadmium and lead above specified quantities.

Name CAS Application Name Expressed As Label Label limit Limit Notes  
Lead and lead compounds
All batteries, accumulators and button cells
As lead
Shall be marked with the chemical symbol for the metal concerned: Hg, Cd or Pb. The symbol indicating the heavy metal content shall be printed beneath the symbol shown in Annex II and shall cover an area of at least one-quarter the size of that symbol.
0.004 %w/w
4 For further labeling requirements see Article 21 Directive 2006/66/EC
Details
CAD - Chemical Agents Directive

CAD - Chemical Agents Directive, Article 2(b)(i) - Hazardous Agents

This list contains a non-exhaustive inventory based on the list of substances with harmonised classification and labelling (i.e., Table 3 of Annex VI to the CLP Regulation 1272/2008/EC). While the harmonised list covers many hazardous substances, others not listed may also meet the classification criteria in accordance with the CLP Regulation.

Name CAS
lead compounds with the exception of those specified elsewhere in this Annex

CAD - Chemical Agents Directive, Annex II - Binding BLVs

This list contains substances assigned a binding biological exposure limit (BEL) by the European Union. National BELs for these substances may not deviate from the limits in the Directive. Annex II contains the binding BEL for lead.

Name CAS BLV Determinant (BLV) Specimen (BLV) Surveillance BLV Surveillance TWA (40 h) Determinant (BLV) surveillance Specimen (Surveillance BLV) Notes  
Lead and its ionic compounds
70 µg/100ml
Lead
B Blood
40 µg/100ml
0.075 mg/m3
Lead
B Blood
2 TWA calculated as a time-weighted average over 40 hours per week.
3 Biological monitoring must be measured using absorption spectrometry or a method giving equivalent results.
Details
Construction Products Regulation

Construction Product Regulation - Annex I (3) - Hazardous Substances

This list contains a non-exhaustive inventory of substances taken from: (1) Table 3 of Annex VI to CLP; (2) the Candidate List of SVHCs; (3) Annex XIV of REACH (Authorisation List); (4) Annex XVII of REACH (Restrictions List); (5) F-gases subject to emission limits/reporting per Regulation 517/2014/EU; and (6) volatile organic compounds (VOCs) listed in the Ambient Air Directive 2008/50/EC. The basis of the list is Annex I(3) of the Construction Products Regulation 305/2011/EC, which stipulates that construction works must not have a high impact on human health or the environment as a result of: giving off toxic gas; emissions of dangerous substances, volatile organic compounds (VOC), greenhouse gases or dangerous particles into indoor or outdoor air; release of dangerous substances into drinking water, ground water, marine waters, surface waters or soil.

Name CAS EU CLP (1272/2008) EU REACH: Annex XIV EU REACH: List of SVHC EU REACH: Annex XVII EU FGG (517/2014) EU VOC (2008/50)
Dioxobis(stearato)trilead
12578-12-0
yes

Construction Product Regulation - Article 6(5) - SDS and Declaration

This list contains a non-exhaustive inventory of substances originating from: (1) Table 3 of Annex VI to CLP (i.e., the list of harmonised substances); (2) the Candidate List of Substances of Very High Concern (SVHCs); and REACH Annex XIV (Authorisation List). This list is compiled on the basis of Article 6(5) of Regulation 305/2011/EC on Marketing of Construction Products. This provision requires SDSs and information on hazardous substances (i.e., SVHCs) contained in construction products be provided with the declaration of performance.

Name CAS EU REACH: Annex XIV EU REACH: List of SVHC
Dioxobis(stearato)trilead
12578-12-0
yes
Cosmetic Products Regulation

Cosmetic Products Regulation, Annex II - Prohibited Substances

This list contains substances which are banned from use in any cosmetic products marketed for sale or use in the European Union.

Ref No. Substance Identification Expressed As Product type, body parts Maximum Threshold Restriction(s) Notes  
Name EC Number CAS Molecular formula
289
Lead and its compounds
All cosmetic products
0 %
Details
End-of-Life Vehicles Directive

End-of-Life Vehicles Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances as defined by Article 2(11) of the End-of-Life Vehicles Directive 2000/53/EC. It is based on the relevant subset of substances with harmonised classification listed in Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

Name CAS EU CLP (1272/2008)
lead compounds with the exception of those specified elsewhere in this Annex
Repr. 1A; Acute Tox. 4; STOT RE 2; Aquatic Acute 1; Aquatic Chronic 1

End-of-Life Vehicles Directive - General Use Exemptions

This list contains the Annex II material and component general use exemptions that apply to the substances prohibited from use in the manufacture of automobiles under Art. 4(2)(a) of the ELV Directive.

Name CAS Notes Operator for Max. Conc. Maximum Concentration Expressed As
Lead and Lead compounds
elv1 According to Article 4 (2)(a) of Directive 2000/53/EC, this substances is prohibited from use in the manufacture of automobiles except for those uses indicated in Annex II of the directive. Refer to Full Text to determine acceptable uses.
0.1 %w/w
As lead

End-of-Life Vehicles Directive - Specific Use Exemptions

This list contains the specific Annex II material and component use exemptions for the substances prohibited from use in the manufacture of automobiles under Art. 4(2)(a) of the ELV Directive.

Materials and components Notes Scope and expiry date of the exemption To be labelled or made identifiable in accordance with Article 4(2)(b)(iv)
Name CAS Reference Exempted application Max. Value Operator Maximum Threshold Min. Value Operator Minimum Threshold Expressed As Notes Exemption Details Label required
Lead and lead compounds
5(a)
Batteries in high-voltage systems that are used only for propulsion in M1 and N1 vehicles
2a Systems that have a voltage of > 75 V DC as defined in Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (OJ L 374, 27.12.2006, p. 10).
Vehicles type-approved before 1 January 2019 and spare parts for these vehicles
yes
Lead and lead compounds
5(b)
Batteries for battery applications not for high-voltage systems that are used only for propulsion in M1 and N1 vehicles
1 This exemption shall be reviewed in 2021.
yes
Lead and lead compounds
6
Vibration dampers
Vehicles type-approved before 1 January 2016 and spare parts for these vehicles
yes
Lead and lead compounds
7(a)
Vulcanising agents and stabilisers for elastomers in brake hoses, fuel hoses, air ventilation hoses, elastomer/metal parts in the chassis applications, and engine mountings
As spare parts for vehicles put on the market before 1 July 2005
Lead and lead compounds
7(b)
Vulcanising agents and stabilisers for elastomers in brake hoses, fuel hoses, air ventilation hoses, elastomer/metal parts in the chassis applications, and engine mountings
0.5 %w/w
As lead
As spare parts for vehicles put on the market before 1 July 2006
Lead and lead compounds
7(c)
Bonding agents for elastomers in powertrain applications
0.5 %w/w
As lead
As spare parts for vehicles put on the market before 1 July 2009
Lead and lead compounds
8(a)
Solders to attach electrical and electronic components to electronic circuit boards and lead in finishes on terminations of components other than electrolyte aluminium capacitors, on component pins and on electronic circuit boards
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2016 and spare parts for these vehicles
yes
Lead and lead compounds
8(b)
Solders in electrical applications other than soldering on electronic circuit boards or on glass
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2011 and spare parts for these vehicles
yes
Lead and lead compounds
8(c)
Finishes on terminals of electrolyte aluminium capacitors
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2013 and spare parts for these vehicles
yes
Lead and lead compounds
8(d)
Soldering on glass in mass airflow sensors
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2015 and spare parts of such vehicles
yes
Lead and lead compounds
8(e)
High melting temperature type solders (i.e. lead-based alloys)
85 %w/w
3 This exemption shall be reviewed in 2024.
yes
Lead and lead compounds
8(f)(a)
Compliant pin connector systems
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2017 and spare parts for these vehicles
yes
Lead and lead compounds
8(f)(b)
Compliant pin connector systems other than the mating area of vehicle harness connectors
Vehicles type-approved before 1 January 2024 and spare parts for these vehicles
yes
Lead and lead compounds
8(g)(i)
Solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages
Vehicles type approved before 1 October 2022 and spare parts for these vehicles
yes
Lead and lead compounds
8(g)(ii)
Solders to complete a viable electrical connection between the semiconductor die and the carrier within integrated circuit flip chip packages where that electrical connection consists of any of the following: (i) a semiconductor technology node of 90 nm or larger; (ii) a single die of 300 mm2 or larger in any semiconductor technology node; (iii) stacked die packages with dies of 300 mm2 or larger, or silicon interposers of 300 mm2 or larger.
3 This exemption shall be reviewed in 2024.
Valid for vehicles type-approved from 1 October 2022 and spare parts for these vehicles
yes
Lead and lead compounds
8(h)
Solder to attach heat spreaders to the heat sink in power semiconductor assemblies with a chip size of at least 1 cm2 of projection area and a nominal current density of at least 1 A/mm2 of silicon chip area
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2016 and after that date as spare parts for these vehicles
yes
Lead and lead compounds
8(i)
Solders in electrical glazing applications on glass except for soldering in laminated glazing
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2016 and after that date as spare parts for these vehicles
yes
Lead and lead compounds
8(j)
Solders for soldering of laminated glazing
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type-approved before 1 January 2020 and after that date as spare parts for these vehicles
yes
Lead and lead compounds
8(k)
Soldering of heating applications with 0.5 A or more of heat current per related solder joint to single panes of laminated glazings not exceeding wall thickness of 2.1 mm. This exemption does not cover soldering to contacts embedded in the intermediate polymer
6 Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
Vehicles type approved before 1 January 2024 and spare parts for these vehicles
yes
Lead and lead compounds
9
Valve seats
As spare parts for engine types developed before 1 July 2003
Lead and lead compounds
10(a)
Electrical and electronic components which contain lead in a glass or ceramic, in a glass or ceramic matrix compound, in a glass-ceramic material, or in a glass-ceramic matrix compound. This exemption does not cover the use of lead in: - glass in bulbs and glaze of spark plugs, - dielectric ceramic materials of components listed under 10(b), 10(c) and 10(d).
7 Dismantling if, in correlation with entries 8(a) to 8(j), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.
X To be labelled or made identifiable in accordance with Article 4(2)(b)(iv) for components other than piezo in engines.
yes
Lead and lead compounds
10(b)
PZT-based dielectric ceramic materials of capacitors being part of integrated circuits or discrete semiconductors
Lead and lead compounds
10(c)
Dielectric ceramic materials of capacitors with a rated voltage of less than 125 V AC or 250 V DC
Vehicles type-approved before 1 January 2016 and spare parts for these vehicles
Lead and lead compounds
10(d)
Dielectric ceramic materials of capacitors compensating the temperature-related deviations of sensors in ultrasonic sonar systems
Vehicles type-approved before 1 January 2017 and after that date as spare parts for these vehicles
Lead and lead compounds
11
Pyrotechnic initiators
Vehicles type-approved before 1 July 2006 and spare parts for these vehicles
Lead and lead compounds
12
Lead-containing thermoelectric materials in automotive electrical applications to reduce CO2 emissions by recuperation of exhaust heat
Vehicles type-approved before 1 January 2019 and spare parts for these vehicles
yes
EU Ecolabel Regulation

Ecolabels - Restrictions for Hazardous Substances/Mixtures

This list contains a non-exhaustive inventory of substances based on the list of hazardous substances with harmonised classification and labelling (i.e. Table 3 of Annex VI to the CLP Regulation), and the Candidate List of substances of very high concern (SVHCs). Pursuant to Article 6(6) of the EU Ecolabel Regulation, the ecolabel must not be awarded to goods containing substances or mixtures classified according to the CLP as toxic; hazardous to the environment; and carcinogenic, mutagenic, or toxic for reproduction (CMRs). Nor are products allowed the ecolabel award when they contain SVHCs (per Article 57 of REACH). While the CLP's harmonised list contains many such substances, other ones not listed in Table 3 may also meet the criteria specified for classification under the CLP.

Name CAS Restriction(s) Expressed As Table 3 of Annex VI to CLP EU REACH: List of SVHC Physical form Substance Description  
Dioxobis(stearato)trilead
12578-12-0
yes
Details
Food Contact Active and Intelligent Materials and Articles Regulation

Active and Intelligent Materials - CMR Substances not allowed for use

This list contains a non-exhaustive list of Carcinogens, Mutagens and Reproductive substances (CMRs) that are not allowed for use in components of active and intelligent materials and articles per Art. 5(2)(c)(i) of Regulation 450/2009/EC. The list is derived from a subset of substances on Table 3 of Annex VI to the CLP Regulation (1272/2008/EC).

Name CAS Index EC Number Substance Description Expressed As Physical form Restriction(s) Classifications
lead compounds with the exception of those specified elsewhere in this Annex
082-001-00-6
Repr. 1A
General Product Safety Directive

General Product Safety Directive - Hazardous Substances

This list contains a non-exhaustive inventory of substances that fall within the European Union's hazardous substance definitions, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annexes XIV and XVII (Authorisation and Restriction lists). They can be considered hazardous for purposes of the General Product Safety Directive 2001/95/EC.

Name CAS EU CLP (1272/2008) EU REACH: Annex XIV EU REACH: List of SVHC EU REACH: Annex XVII EU_BA Directive 2000/54/EC
Dioxobis(stearato)trilead
12578-12-0
yes
In Vitro Diagnostic Medical Devices Directive

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
Dioxobis(stearato)trilead
12578-12-0
yes
Industrial Emissions Directive

IPPC - Industrial Emissions Directive, Annex II - Polluting Substances

This list contains the polluting substances for which emission limit values are assigned under Directive 2010/75/EU on Industrial Emissions (Integrated Pollution Prevention and Control - IPPC). Member States must permit all qualifying facilities in order to ensure that they minimize impact on the environment. The permit issued must provide emission limit values for pollutants on this list.

Name CAS Air Water Annex X of Dir 2000/60/EC
Lead compounds
yes
yes

IPPC, Annexes V, VI, VIII - Provisions relating to industrial plants

This list contains emission limit values for polluting substances in waste gases and waste water, assigned according to facility type (i.e., combustion plants (Annex V), waste incineration/co-incineration plants (Annex VI), and installations producing titanium dioxide (Annex VIII)), under Directive 2010/75/EU on Industrial Emissions (Integrated Pollution Prevention and Control - IPPC). For this list, if a substance presents 2 values in the ''Average sampling duration'' field, these indicate minimum and maximum average sampling period.

Name CAS Expressed As Annex Group Average duration qualifier Average limit Maximum limit Average sampling duration Emission medium fuel Fuel class Part Point Thermal input Process/equipment Qualifier Notes  
Lead and its compounds
As lead
VI Annex VI (Directive 2010/75/EU) Technical provisions relating to waste incineration plants and waste co-incineration plants
0.2 mg/l
Waste water from the cleaning of waste gases
Part 5 (VI) Emission limit values for discharges of waste water from the cleaning of waste gases
Waste incineration plants and waste co-incineration plants
Details
Lead and its compounds
As lead
VI Annex VI (Directive 2010/75/EU) Technical provisions relating to waste incineration plants and waste co-incineration plants
Antimony, arsenic, lead, chromium, cobalt, copper, manganese, nickel and vanadium and their compounds
0.5 mg/Nm3
0.5 h
8 h
Waste gases
Part 3 (VI) Air emission limit values for waste incineration plants
1.3
Waste incineration plants
21 All emission limit values shall be calculated at a temperature of 273,15 K, a pressure of 101,3 kPa and after correcting for the water vapour content of the waste gases.They are standardised at 11 % oxygen in waste gas except in case of incineration of mineral waste oil as defined in point 3 of Article 3 of Directive 2008/98/EC, when they are standardised at 3 % oxygen, and in the cases referred to in Point 2.7 of Part 6
22 These average values cover also the gaseous and the vapour forms of the relevant heavy metal emissions as well as their compounds
24 Emission limit value defined as total emission limit for the total sum of antimony, arsenic, lead, chromium, cobalt, copper, manganese, nickel and vanadium, expressed as average value over the sampling period
39 For technical provisions regarding 'Monitoring of emissions' see Part 6 (Annex VI). For 'Formula to calculate the emission concentration at the standard percentage oxygen concentration' see Part 7 (Annex VI). For 'Assessment of compliance with emission limit values' see Part 8 (Annex VI) Directive 2010/75/EU
Details
Lead and its compounds
As lead
VI Annex VI (Directive 2010/75/EU) Technical provisions relating to waste incineration plants and waste co-incineration plants
Antimony, arsenic, lead, chromium, cobalt, copper, manganese, nickel and vanadium and their compounds
0.5 mg/Nm3
0.5 h
8 h
Waste gases
Part 4 (VI) Determination of air emission limit values for the co-incineration of waste
2.2
Cement kilns co-incinerating waste
22 These average values cover also the gaseous and the vapour forms of the relevant heavy metal emissions as well as their compounds
24 Emission limit value defined as total emission limit for the total sum of antimony, arsenic, lead, chromium, cobalt, copper, manganese, nickel and vanadium, expressed as average value over the sampling period
28 All values are standardised at 10 % oxygen
30 All emission limit values shall be calculated at a temperature of 273,15 K, a pressure of 101,3 kPa and after correcting for the water vapour content of the waste gases
39 For technical provisions regarding 'Monitoring of emissions' see Part 6 (Annex VI). For 'Formula to calculate the emission concentration at the standard percentage oxygen concentration' see Part 7 (Annex VI). For 'Assessment of compliance with emission limit values' see Part 8 (Annex VI) Directive 2010/75/EU
Details
Lead and its compounds
As lead
VI Annex VI (Directive 2010/75/EU) Technical provisions relating to waste incineration plants and waste co-incineration plants
Antimony, arsenic, lead, chromium, cobalt, copper, manganese, nickel and vanadium and their compounds
0.5 mg/Nm3
0.5 h
8 h
Waste gases
Solid or liquid
Part 4 (VI) Determination of air emission limit values for the co-incineration of waste
3.3
Combustion plants co-incinerating waste
22 These average values cover also the gaseous and the vapour forms of the relevant heavy metal emissions as well as their compounds
24 Emission limit value defined as total emission limit for the total sum of antimony, arsenic, lead, chromium, cobalt, copper, manganese, nickel and vanadium, expressed as average value over the sampling period
30 All emission limit values shall be calculated at a temperature of 273,15 K, a pressure of 101,3 kPa and after correcting for the water vapour content of the waste gases
34 O2 content 6% for solid fuels and 3% for liquid fuels
39 For technical provisions regarding 'Monitoring of emissions' see Part 6 (Annex VI). For 'Formula to calculate the emission concentration at the standard percentage oxygen concentration' see Part 7 (Annex VI). For 'Assessment of compliance with emission limit values' see Part 8 (Annex VI) Directive 2010/75/EU
Details
Marine Environmental Policy Framework Directive

Marine Environmental Policy Framework Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances for purposes of the Marine Strategy Framework Directive, especially as it concerns Art. 3(8), and Annexes I and III. The listed substances meet the European Union's definitions as hazardous, as provided on: (1) Table 3 of Annex VI to the CLP Regulation (1272/2008/EC); (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annex XIV (Authorisation List).

Name CAS EU CLP (1272/2008) EU REACH: List of SVHC EU_BA Directive 2000/54/EC EU REACH: Annex XIV
Dioxobis(stearato)trilead
12578-12-0
yes
Medical Devices Directive

Medical Devices Directive - Hazardous Substances

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
Dioxobis(stearato)trilead
12578-12-0
yes
Protection of Pregnant and Breastfeeding Workers Directive

Protection of Pregnant and Breastfeeding Workers Directive, Annex I+II

This list contains a non-exhaustive inventory of substances to which pregnant workers and workers who have recently given birth or are breastfeeding may not be exposed. Employers are obligated to prevent the exposure of these workers to any agents that may have adverse health effects on either mother or child. The inventory originates from Table 3 of Annex VI to the CLP.

Name CAS CLP (1272/2008) CMRs ECCAR Directive 2004/37/EC EU_BA PREGW Notes  
lead compounds with the exception of those specified elsewhere in this Annex
Repr. 1A
Details
Protection of Young People Directive

Physical, Biological and Chemical Agents & Processes and Work

This list contains biological and chemical agents, in accordance with Art. 7 and points 2 and 3 of the Annex to Directive 94/33/EC, to which young persons (under 18 years of age) may not be exposed at the workplace. The list is a non-exhaustive inventory of such substances based on: 1) agents of risk groups 3 and 4 under Directive 2000/54/EC; 2) Table 3 of Annex VI to the CLP Regulation; 3) and Annex I of Directive 2004/37/EC.

Name CAS EC_YOUNG ECCAR Directive 2004/37/EC EU CLP (1272/2008) EU_BA Directive 2000/54/EC Notes  
Lead compounds, in as much as the agents in question are absorbable by the human organism
yes
Repr. 1A; STOT RE 2
1 1. Included in the ''Non-exhaustive list of agents, processes and work'' against which young people must be protected. 2. Member States shall ensure that young people are protected from any specific risks to their safety, health and development which are a consequence of their lack of experience, or absence of awareness of existing or potential risks or of the fact that young people have not yet fully matured. 3. Work which is likely to entail specific risks for young people within the...
4 Listed in point I.3. of the Annex, ''Chemical agents'', subsection (e).
Details
RoHS - Restriction of Hazardous Substances in Electrical & Electronic Equipment Directive

ROHS - Exemptions from Article 4(1) Restrictions, Annexes III & IV

This list contains the application exemptions listed in Annexes III and IV to RoHS (2011/65/EU). Annex III contains applications exempted from the restriction in Article 4(1), while Annex IV lists applications exempted from the restriction in Article 4(1) specific to medical devices and monitoring and control instruments.

Name CAS Annex Application Begin date Cut-off Expiration Date Expressed As Part Reference Restriction(s) Note(s)  
Lead and lead compounds
III
In glass of cathode ray tubes
5(a)
Details
Lead and lead compounds
III
In glass of fluorescent tubes
0.2 %w/w
5(b)
Details
Lead and lead compounds
III
As an alloying element in steel for machining purposes and in galvanised steel
0.35 %w/w
07/21/2021
6(a)
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Details
Lead and lead compounds
III
As an alloying element in steel for machining purposes and in galvanised steel
0.35 %w/w
07/21/2023
6(a)
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
As an alloying element in steel for machining purposes and in galvanised steel
0.35 %w/w
07/21/2024
6(a)
Applies to category 9 industrial monitoring and control instruments, and for category 11
Details
Lead and lead compounds
III
As an alloying element in steel for machining purposes in batch hot dip galvanised steel components containing up to 0.2 % lead by weight
0.35 %w/w
07/21/2021
6(a)-I
Applies to categories 1-7 and 10
Details
Lead and lead compounds
III
As an alloying element in aluminium
0.4 %w/w
07/21/2021
6(b)
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Details
Lead and lead compounds
III
As an alloying element in aluminium
0.4 %w/w
07/21/2023
6(b)
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
As an alloying element in aluminium
0.4 %w/w
07/21/2024
6(b)
Applies to category 9 industrial monitoring and control instruments, and for category 11
Details
Lead and lead compounds
III
As an alloying element in aluminium, provided it stems from lead-bearing aluminium scrap recycling
0.4 %w/w
07/21/2021
6(b)-I
Applies to categories 1-7 and 10
Details
Lead and lead compounds
III
As an alloying element in aluminium for machining purposes
0.4 %w/w
05/18/2021
6(b)-II
Applies to categories 1-7 and 10
Details
Lead and lead compounds
III
Copper alloy
4 %w/w
07/21/2021
6(c)
Applies tocategories 1-7 and 10
Details
Lead and lead compounds
III
Copper alloy
4 %w/w
07/21/2021
6(c)
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Details
Lead and lead compounds
III
Copper alloy
4 %w/w
07/21/2023
6(c)
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
Copper alloy
4 %w/w
07/21/2024
6(c)
Applies to category 9 industrial monitoring and control instruments, and for category 11
Details
Lead and lead compounds
III
In high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)
07/21/2021
7(a)
Applies to categories 1-7 and 10 (except applications covered by point 24 of this Annex)
Details
Lead and lead compounds
III
In high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)
07/21/2021
7(a)
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Details
Lead and lead compounds
III
In high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)
07/21/2023
7(a)
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
In high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)
07/21/2024
7(a)
Applies to category 9 industrial monitoring and control instruments, and for category 11
Details
Lead and lead compounds
III
In solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission, and network management for telecommunications
7(b)
Details
Lead and lead compounds
III
Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound
07/21/2021
7(c)-I
Applies to categories 1-7 and 10 (except applications covered under point 34)
Details
Lead and lead compounds
III
Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound
07/21/2021
7(c)-I
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Details
Lead and lead compounds
III
Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound
07/21/2023
7(c)-I
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound
07/21/2024
7(c)-I
Applies to category 9 industrial monitoring and control instruments, and for category 11
Details
Lead and lead compounds
III
In dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher
7(c)-II
Details
Lead and lead compounds
III
In dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC
01/01/2013
7(c)-III
Expires on 1 January 2013 and after that date may be used in spare parts for EEE placed on the market before 1 January 2013
Details
Lead and lead compounds
III
In PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductors
07/21/2016
7(c)-IV
Details
Lead and lead compounds
III
In bearing shells and bushes for refrigerant-containing compressors for heating, ventilation, air conditioning and refrigeration (HVACR) applications
07/21/2023
9(b)
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
In bearing shells and bushes for refrigerant-containing compressors for heating, ventilation, air conditioning and refrigeration (HVACR) applications
07/21/2024
9(b)
Applies to category 9 industrial monitoring and control instruments and for category 11
Details
Lead and lead compounds
III
In bearing shells and bushes for refrigerant-containing compressors for heating, ventilation, air conditioning and refrigeration (HVACR) applications
07/21/2021
9(b)
Applies to other subcategories of categories 8 and 9
Details
Lead and lead compounds
III
In bearing shells and bushes for refrigerant- containing hermetic scroll compressors with a stated electrical power input equal or below 9 kW for heating, ventilation, air conditioning and refrigeration (HVACR) applications
07/21/2019
9(b)-(I)
Applies to category 1
Details
Lead and lead compounds
III
In C-press compliant pin connector systems
09/24/2010
11(a)
May be used in spare parts for EEE placed on the market before 24 September 2010
Details
Lead and lead compounds
III
In other than C-press compliant pin connector systems
01/01/2013
11(b)
Expires on 1 January 2013 and after that date may be used in spare parts for EEE placed on the market before 1 January 2013
Details
Lead and lead compounds
III
As a coating material for the thermal conduction module C-ring
09/24/2010
12
May be used in spare parts for EEE placed on the market before 24 September 2010
Details
Lead and lead compounds
III
In white glasses used for optical applications
07/21/2021
13(a)
Applies to all categories and subcategories other than category 8, category 9 and category 11
Details
Lead and lead compounds
III
In white glasses used for optical applications
07/21/2023
13(a)
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
In white glasses used for optical applications
07/21/2024
13(a)
Applies to category 9 industrial monitoring and control instruments and for category 11
Details
Lead and lead compounds
III
In filter glasses and glasses used for reflectance standards
07/21/2023
13(b)
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
In filter glasses and glasses used for reflectance standards
07/21/2024
13(b)
Applies to category 9 industrial monitoring and control instruments and for category 11
Details
Lead and lead compounds
III
In filter glasses and glasses used for reflectance standards
07/21/2021
13(b)
Applies to other subcategories of categories 8 and 9
Details
Lead and lead compounds
III
In ion coloured optical filter glass types
07/21/2021
13(b)-(I)
Applies to categories 1 to 7 and 10
Details
Lead and lead compounds
III
In glazes used for reflectance standards
07/21/2021
13(b)-(III)
Applies to categories 1 to 7 and 10
Details
Lead and lead compounds
III
In solders consisting of more than two elements for the connection between the pins and the package of microprocessors with a lead content of more than 80 % and less than 85 % by weight
01/01/2011
14
Expired on 1 January 2011 and after that date may be used in spare parts for EEE placed on the market before 1 January 2011
Details
Lead and lead compounds
III
In solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages
15
Details
Lead and lead compounds
III
In linear incandescent lamps with silicate coated tubes
09/01/2013
16
Details
Lead and lead compounds
III
As activator in the fluorescent powder (1 % lead by weight or less) of discharge lamps when used as speciality lamps for diazoprinting reprography, lithography, insect traps, photochemical and curing processes containing phosphors such as SMS ((Sr,Ba)2MgSi2O7:Pb)
01/01/2011
18(a)
Details
Lead and lead compounds
III
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)
18(b)
Details
Lead and lead compounds
III
With PbBiSn-Hg and PbInSn-Hg in specific compositions as main amalgam and with PbSn-Hg as auxiliary amalgam in very compact energy saving lamps (ESL)
06/01/2011
19
Details
Lead and lead compounds
III
In printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses
21
Details
Lead and lead compounds
III
In finishes of fine pitch components other than connectors with a pitch of 0.65 mm and less
23
May be used in spare parts for EEE placed on the market before 24 September 2010
Details
Lead and lead compounds
III
In solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors
07/21/2021
24
Applies to categories 1-7 and 10
Details
Lead and lead compounds
III
In solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors
07/21/2021
24
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Details
Lead and lead compounds
III
In solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors
07/21/2023
24
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
In solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors
07/21/2023
24
Applies to category 9 industrial monitoring and control instruments, and for category 11
Details
Lead and lead compounds
III
Bound in crystal glass
29
As defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC
OJ L 326, 29.12.1969, p. 36
Details
Lead and lead compounds
III
In soldering materials in mercury free flat fluorescent lamps (which, e.g. are used for liquid crystal displays, design or industrial lighting)
31
Details
Lead and lead compounds
III
In solders for the soldering of thin copper wires of 100 µm diameter and less in power transformers
33
Details
Lead and lead compounds
III
In cermet-based trimmer potentiometer elements
07/21/2021
34
Applies to categories 1-7 and 10
Details
Lead and lead compounds
III
In cermet-based trimmer potentiometer elements
07/21/2021
34
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Details
Lead and lead compounds
III
In cermet-based trimmer potentiometer elements
07/21/2023
34
Applies to category 8 in vitro diagnostic medical devices
Details
Lead and lead compounds
III
In cermet-based trimmer potentiometer elements
07/21/2024
34
Applies to category 9 industrial monitoring and control instruments, and for category 11
Details
Lead and lead compounds
III
In the plating layer of high voltage diodes on the basis of a zinc borate glass body
37
Details
Lead and lead compounds
III
In solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council)
03/31/2022
41
Applies to categories 1 to 7, 10 and 11
Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).
Details
Lead and lead compounds
III
In bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment: with engine total displacement ≥ 15 litres, or with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds, or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications
07/21/2024
42
Applies to category 11, excluding applications covered by entry 6(c) of this Annex
Details
Lead and lead compounds
III
In solder of sensors, actuators, and engine control units of combustion engines, installed in equipment used at fixed positions while in operation which is designed for professionals, but also used by non-professional users
07/21/2024
44
Within the scope of Regulation (EU) 2016/1628 of the European Parliament and of the Council
Applies to category 11
Details
Lead and lead compounds
IV
Equipment utilising or detecting ionising radiation: In detectors for ionising radiation
1
Details
Lead and lead compounds
IV
Equipment utilising or detecting ionising radiation: Bearings in X-ray tubes
2
Details
Lead and lead compounds
IV
Equipment utilising or detecting ionising radiation: In electromagnetic radiation amplification devices: micro-channel plate and capillary plate
3
Details
Lead and lead compounds
IV
Equipment utilising or detecting ionising radiation: In glass frit of X-ray tubes and image intensifiers and lead in glass frit binder for assembly of gas lasers and for vacuum tubes that convert electromagnetic radiation into electrons
4
Details
Lead and lead compounds
IV
Equipment utilising or detecting ionising radiation: In shielding for ionising radiation
5
Details
Lead and lead compounds
IV
Equipment utilising or detecting ionising radiation: In X-ray test objects
6
Details
Lead and lead compounds
IV
Sensors, detectors and electrodes: In ion selective electrodes including glass of pH electrodes
1a
Details
Lead and lead compounds
IV
Sensors, detectors and electrodes: Anodes in electrochemical oxygen sensors
1b
Details
Lead and lead compounds
IV
Sensors, detectors and electrodes: In infra-red light detectors
1c
Details
Lead and lead compounds
IV
In atomic absorption spectroscopy lamps
10
Details
Lead and lead compounds
IV
In alloys as a superconductor and thermal conductor in MRI
11
Details
Lead and lead compounds
IV
In metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors
06/30/2021
12
Details
Lead and lead compounds
IV
In counterweights
13
Details
Lead and lead compounds
IV
In single crystal piezoelectric materials for ultrasonic transducers
14
Details
Lead and lead compounds
IV
In solders for bonding to ultrasonic transducers
15
Details
Lead and lead compounds
IV
In solders in portable emergency defibrillators
17
Details
Lead and lead compounds
IV
In solders of high performance infrared imaging modules to detect in the range 8-14 µm
18
Details
Lead and lead compounds
IV
In Liquid crystal on silicon (LCoS) displays
19
Details
Lead and lead compounds
IV
As an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation
06/30/2021
23
Details
Lead and lead compounds
IV
Enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers
12/31/2019
24
Details
Lead and lead compounds
IV
In the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below - 20 °C under normal operating and storage conditions
06/30/2021
25
Details
Lead and lead compounds
IV
Solders on printed circuit boards which are used durably at a temperature below - 20 °C under normal operating and storage conditions
06/30/2021
26(a)
Details
Lead and lead compounds
IV
Termination coatings of electrical and electronic components and coatings of printed circuit boards which are used durably at a temperature below - 20 °C under normal operating and storage conditions
06/30/2021
26(b)
Details
Lead and lead compounds
IV
Solders for connecting wires and cables which are used durably at a temperature below - 20 °C under normal operating and storage conditions
06/30/2021
26(c)
Details
Lead and lead compounds
IV
Solders connecting transducers and sensors which are used durably at a temperature below - 20 °C under normal operating and storage conditions
06/30/2021
26(d)
Details
Lead and lead compounds
IV
Solders of electrical connections to temperature measurement sensors in devices which are designed to be used periodically at temperatures below - 150 °C
06/30/2021
26
Details
Lead and lead compounds
IV
Solders which are used in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere
06/30/2020
27(a)
Details
Lead and lead compounds
IV
Solders which are used in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy
06/30/2020
27(b)
Details
Lead and lead compounds
IV
Termination coatings of electrical and electronic components and printed circuit boards which are used in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere
06/30/2020
27(a)
Details
Lead and lead compounds
IV
Termination coatings of electrical and electronic components and printed circuit boards which are used in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy
06/30/2020
27(b)
Details
Lead and lead compounds
IV
Connections of electrical wires, shields and enclosed connectors which are used in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere
06/30/2020
27(a)
Details
Lead and lead compounds
IV
Connections of electrical wires, shields and enclosed connectors which are used in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy
06/30/2020
27(b)
Details
Lead and lead compounds
IV
In solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards
12/31/2017
28
Details
Lead and lead compounds
IV
In alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments
06/30/2021
29
Details
Lead and lead compounds
IV
In spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer
07/21/2021
31a(a)
For the use in medical devices other than in vitro diagnostic medical devices
Details
Lead and lead compounds
IV
In spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer
07/21/2023
31a(b)
For the use in in vitro diagnostic medical devices
Details
Lead and lead compounds
IV
In spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer
07/21/2024
31a(c)
For the use in electron microscopes and their accessories
Details
Lead and lead compounds
IV
In solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging equipment
12/31/2019
32
Details
Lead and lead compounds
IV
In solders on populated printed circuit boards used in Directive 93/42/EEC class IIa mobile medical devices other than portable emergency defibrillators
06/30/2016
33
Details
Lead and lead compounds
IV
In solders on populated printed circuit boards used in Directive 93/42/EEC class IIb mobile medical devices other than portable emergency defibrillators
12/31/2020
33
Details
Lead and lead compounds
IV
As an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors
07/22/2021
34
Details
Lead and lead compounds
IV
Used in other than C-press compliant pin connector systems for industrial monitoring and control instruments
12/31/2020
36
May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021
Details
Lead and lead compounds
IV
In platinized platinum electrodes used for conductivity measurements
12/31/2025
37
At least one of the following conditions applies: (a) wide-range measurements with a conductivity range covering more than 1 order of magnitude (e.g. range between 0,1 mS/m and 5 mS/m) in laboratory applications for unknown concentrations, (b) measurements of solutions where an accuracy of +/- 1 % of the sample range and where high corrosion resistance of the electrode are required for any of the following: (i) solutions with an acidity < pH 1, (ii) solutions with an alkalinity > pH 13, (iii) corrosive solutions containing halogen gas, (c) measurements of conductivities above 100 mS/m that must be performed with portable instruments
Details
Lead and lead compounds
IV
In solder in one interface of large area stacked die elements with more than 500 interconnects per interface which are used in X-ray detectors of computed tomography and X-ray systems
12/31/2019
38
May be used after that date in spare parts for CT and X-ray systems placed on the market before 1 January 2020
Details
Lead and lead compounds
IV
In micro-channel plates (MCPs) used in equipment for medical devices and monitoring and control instruments
07/21/2021
39
At least one of the following properties is present: (a) a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable, (b) a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies: (i) a response time shorter than 25 ns, (ii) a sample detection area larger than 149 mm 2, (iii) a multiplication factor larger than 1.3 x 10^3 (c) a response time shorter than 5 ns for detecting electrons or ions, (d) a sample detection area larger than 314 mm2 for detecting electrons or ions, (e) a multiplication factor larger than 4.0 x 10^7
Details
Lead and lead compounds
IV
In micro-channel plates (MCPs) used in equipment for in-vitro diagnostic medical devices
07/21/2023
39
At least one of the following properties is present: (a) a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable, (b) a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies: (i) a response time shorter than 25 ns, (ii) a sample detection area larger than 149 mm 2, (iii) a multiplication factor larger than 1.3 x 10^3 (c) a response time shorter than 5 ns for detecting electrons or ions, (d) a sample detection area larger than 314 mm2 for detecting electrons or ions, (e) a multiplication factor larger than 4.0 x 10^7
Details
Lead and lead compounds
IV
In micro-channel plates (MCPs) used in equipment for industrial monitoring and control instruments
07/21/2024
39
At least one of the following properties is present: (a) a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable, (b) a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies: (i) a response time shorter than 25 ns, (ii) a sample detection area larger than 149 mm 2, (iii) a multiplication factor larger than 1.3 x 10^3 (c) a response time shorter than 5 ns for detecting electrons or ions, (d) a sample detection area larger than 314 mm2 for detecting electrons or ions, (e) a multiplication factor larger than 4.0 x 10^7
Details
Lead and lead compounds
IV
In dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments
12/31/2020
40
May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021
Details
Lead and lead compounds
IV
As a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases
03/31/2022
41
Details
Lead and lead compounds
III
In solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council)
07/21/2021
41
Applies to categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments
Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).
Details
Lead and lead compounds
III
In solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council)
07/21/2023
41
Applies to category 8 in vitro diagnostic medical devices
Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).
Details
Lead and lead compounds
III
In solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council)
07/21/2024
41
Applies to category 9 industrial monitoring and control instruments
Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).
Details

ROHS Directive - Restricted Substances as per Article 4(1), Annex II

This list contains the substances listed in Annex II to the Directive on the restriction of hazardous substances in electrical and electronic equipment (RoHS - 2011/65/EU). Restricted per Art. 4(1) of RoHS, each listed substance includes a maximum concentration value tolerated by weight in homogeneous materials.

Name CAS Max Conc % wt Notes
Lead and its compounds
0.1 %w/w
1 See Full Text for exemptions and other information.
Safety and Health of Workers at Work Directive

Safety and Health of Workers at Work Directive - Hazardous Substances

This list contains a non-exhaustive inventory of substances that fall within the scope of the European Union's definition of hazardous chemical and biological substances, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; and (2) Annex III of Directive 2000/54/EC (Biological Agents). The EU's Occupational Safety and Health (OSH) Framework Directive 89/391/EEC applies to risks arising from chemical, physical and biological agents at the workplace.

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC
lead compounds with the exception of those specified elsewhere in this Annex
Repr. 1A; Acute Tox. 4; STOT RE 2
Safety and/or Health Signs at Work Directive

Workplace Signs - minimum requirements & signs on containers and pipes

This list contains hazardous substances based on Table 3 of Annex VI to the CLP Regulation 1272/2008/EC. According to the annexes to Directive 92/58/EEC, storage areas and containers containing chemical substances or mixtures that are classified as hazardous according to the CLP Regulation must be duly marked and/or labeled. Directive 92/58/EEC requires employers to ensure proper signage is posted in areas where hazards cannot be avoided or reduced.

Name EC Number CAS Index Sustance Description Danger Symbols Restriction Physical form  
lead compounds with the exception of those specified elsewhere in this Annex
082-001-00-6
Health hazard
Exclamation mark
Details
Toy Safety Directive

Toy Safety Directive - Substances Restricted in Toys

This list contains substances whose use in toys is restricted in the European Union in accordance with points 8 and 13, Part III, and Appendices A and C of Annex II (Particular Safety Requirements) to Directive 2009/48/EC on toy safety. List entries include substance name, CAS number, limit values for certain product types and, where applicable, notes on restrictions.

Name CAS Application Name Expressed As Content limit Emission Limit Restriction(s) SML Notes  
Lead and its compounds
Dry, brittle, powder-like or pliable toy material
As lead
Banned if exceeded the migration limit (without prejudice to points 3, 4 and 5, Part III, Annex II)
2 mg/kg
Point 13, Part III, Annex II
These limit values shall not apply to toys or components of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when used as specified in the first subparagraph of Article 10(2)
Details
Lead and its compounds
Liquid or sticky toy material
As lead
Banned if exceeded the migration limit (without prejudice to points 3, 4 and 5, Part III, Annex II)
0.5 mg/kg
Point 13, Part III, Annex II
These limit values shall not apply to toys or components of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when used as specified in the first subparagraph of Article 10(2)
Details
Lead and its compounds
Scraped-off toy material
As lead
Banned if exceeded the migration limit (without prejudice to points 3, 4 and 5, Part III, Annex II)
23 mg/kg
Point 13, Part III, Annex II
These limit values shall not apply to toys or components of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when used as specified in the first subparagraph of Article 10(2)
Details
Water Environmental Quality Standards Directive

Annex I, Part A - Priority Substances & Pollutants in water

This list contains environmental quality standards (EQS), including annual averages and maximum allowable concentrations, for priority substances and certain other pollutants, as provided for in Article 16 of Directive 2000/60/EC establishing a framework for Community action in the field of water policy.

Name CAS NO Average limit Maximum limit Average sampling duration Emission medium Qualifier  
Lead and its compounds
20
1.2 µg/l
14 µg/l
1 yr
Inland surface waters
Details
Lead and its compounds
20
1.3 µg/l
14 µg/l
1 yr
Surface waters other than inland surface waters
Details
Water Framework Directive

Water Framework Directive, Annex X - Priority Substances

This list contains substances identified as priority substances that are targeted for reduction and eventual removal from waste water discharge. The list includes 'priority hazardous substances' which are subject to special restrictions.

Name EC Number CAS Priority Group Notes  
Lead compounds
Details
WFD - Waste Framework Directive

Waste Framework Directive, Annex III - Waste - Hazardous Properties

This list contains substances that have been assigned hazard property (HP) waste codes 1-15, as defined in terms of the hazard class and category, hazard (H) statement, and/or concentration limits provided in Annex III of the Waste Framework Directive 2008/98/EC. The classifications of the substances listed in the list are based on their harmonised classifications per Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

Name EC Number CAS EU CLP (1272/2008) HP Code Index
lead compounds with the exception of those specified elsewhere in this Annex
Repr. 1A
Acute Tox. 4
STOT RE 2
Aquatic Acute 1
Aquatic Chronic 1
HP10 Toxic for reproduction: waste which has adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.
HP6 Acute Toxicity: waste which can cause acute toxic effects following oral or dermal administration, or inhalation exposure.
HP5 Specific Target Organ Toxicity (STOT)/Aspiration Toxicity: waste which can cause specific target organ toxicity either from a single or repeated exposure, or which cause acute toxic effects following aspiration.
HP14 Ecotoxic: waste which presents or may present immediate or delayed risks for one or more sectors of the environment.
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