Conformity Assessment Procedure for Hazardous Substances in Electrical Equipment (RoHS II)

Hazardous Substances in Electrical and Electronic Equipment - RoHS II

Electrical and electronic equipment (hereinafter referred to as “electrical equipment”) consists of specific products defined by Act No. 22/1997 Coll., which fall within the harmonized scope. Furthermore, electrical equipment must comply with requirements regarding the restriction of the use of hazardous substances and other conditions for placing electrical equipment on the market. Provisions regarding the restriction of hazardous substances in electrical and electronic equipment are set forth in Government Regulation No. 481/2012 Coll., which implements the EU regulation—Directive 2011/65/EU of the European Parliament and of the Council (RoHS II)—as amended on January 1, 2025. The abbreviation RoHS stands for Restriction of Hazardous Substances. In connection with Directive 2011/65/EU of the European Parliament and of the Council (RoHS II), a number of Commission delegated acts have been issued, which are not and will not be implemented into Czech legislation due to the provisions of Section 4(3) of Government Regulation No. 481/2012 Coll. on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Directive 2011/65/EU of the European Parliament and of the Council (RoHS II) introduces new rules for granting exemptions for restricted substances. Applications for the granting, extension, or revocation of an exemption shall be submitted to the Commission in accordance with Annex V to this Directive. Commission Delegated Directives issued pursuant to Directive 2011/65/EU of the European Parliament and of the Council (RoHS II) contain provisions and conditions under which hazardous substances may be used in electrical and electronic equipment. These Commission Directives have direct effect in the Czech Republic and have all entered into force (January 2014 and June 2014); an overview of them is provided here.

Annex No. 1 to Government Regulation No. 481/2012 Coll. contains a list of hazardous substances restricted by this regulation, supplemented by their maximum permitted concentrations.

Restricted substance	Maximum concentration by weight
Lead	0.1%
Mercury	0.1%
Cadmium	0.01%
Hexavalent chromium	0.1%
Polybrominated biphenyls (PBB)	0.1%
Polybrominated diphenyl ethers (PBDE)	0.1%
Bis(2-ethylhexyl) phthalate (DEHP)*	0.1%
Butylbenzyl phthalate (BBP)*	0.1%
Dibutyl phthalate (DBP)*	0.1%
Diisobutyl phthalate (DIBP)*	0.1%

* The restriction on DEHP, BBP, DBP, and DIBP applies from July 22, 2021, to in vitro diagnostic medical devices and monitoring and control instruments, which also include industrial monitoring and control instruments; The restrictions on DEHP, BBP, and DBP do not apply to toys covered by the restriction in entry 51 of Annex XVII to the REACH Regulation. It
applies from July 22, 2019; implementation by Member States is due by December 31, 2016.

The European Commission has the authority to review and amend the list of restricted substances in Annex II to Directive 2011/65/EU of the European Parliament and of the Council (RoHS II). This review and the amendments to the list must be consistent with other legislation concerning chemical substances, in particular the REACH Regulation (No. 1907/2006), and must take into account, among other things, Annexes XIV and XVII of the REACH Regulation. The review will focus on nanomaterials, HBCDD, DEHP, BBP, and DBP. (HBCDD – hexabromocyclododecane, DEHP – di-(2-ethylhexyl) phthalate, BBP – benzyl butyl phthalate, DBP – dibutyl phthalate). During this review, the Commission will consult with stakeholders, including economic operators, recycling operators, waste processors, environmental organizations, and employee and consumer associations.

Annex 2 of Government Regulation No. 481/2012 Coll. lists the applications that are exempt from the restrictions, along with their scope and duration. This annex contains a total of 39 exemptions.

The obligations regarding the restriction of certain hazardous substances used in electrical equipment have different effective dates depending on the category:

Covered products	Effective Date
Large household appliances	January 2, 2013
Small household appliances	January 2, 2013
Information technology and telecommunications equipment	January 2, 2013
Consumer electronics	January 2, 2013
Lighting equipment	January 2, 2013
Electrical and electronic tools (excluding large-scale stationary industrial tools)	January 2, 2013
Toys, leisure, and sports equipment	January 2, 2013
Vending machines	January 2, 2013
Medical devices**	July 22, 2014
In vitro diagnostic medical devices	July 22, 2016
Monitoring and control instruments, including industrial monitoring and control instruments****	July 22, 2017
Other EEE not falling under any of the above categories***	July 22, 2019

** excluding active implantable medical devices

*** open scope

**** The Ministry of Industry and Trade has issued a notice to manufacturers, authorized representatives of manufacturers, importers, and distributors of industrial monitoring and control instruments that Government Regulation No. 481/2012 Coll., as amended by Government Regulation No. 391/2016 Coll., will apply to this product subgroup of electrical equipment effective July 22, 2017.

Government Regulation No. 481/2012 Coll. provides a precise definition of electrical equipment and its classification into categories. Government Regulation No. 481/2012 Coll. applies to electrical equipment for which the alternating voltage does not exceed 1,000 V and the direct voltage does not exceed 1,500 V.

Equipment not covered by Government Regulation No. 481/2012 Coll. is listed in paragraph 3 of Section 2.

Obligations of the manufacturer of electrical equipment prior to placing it on the market:

1. ensure compliance with requirements for the restriction of hazardous substances;

2. prepare technical documentation and retain it for a period of 10 years after the electrical equipment is placed on the market;

3. assess conformity (through internal production control, meaning that the manufacturer of electrical equipment, on its own responsibility, guarantees and declares that the products in question meet the requirements of the applicable legal regulations);

— prepare technical documentation containing a general description of the product, conceptual design, manufacturing drawings, component diagrams, results of design calculations and inspections performed, test reports, and a list of European harmonized standards or specifications with references published in the Official Journal of the EU that were used to meet the essential requirements

— take the necessary measures in the manufacture of electrical equipment to ensure that the manufacturing process and its control ensure the conformity of the manufactured products with the technical documentation and with the requirements of the applicable legislation,

— issue a written EU declaration of conformity with the requirements of the applicable legislation and keep it for a period of 10 years,

— affix the CE marking to each product (visibly, legibly, and indelibly affixed to the finished electrical equipment or its nameplate; if this is not possible, it must be affixed to the packaging and accompanying documents),

4. ensure that serial production remains in conformity;

5. keep records of non-compliant electrical equipment and the measures taken, and share this information with distributors;

6. mark the product (or accompanying documents) with a type, serial number, or code enabling product identification;

7. mark the product with the company name and address where it can be contacted;

8. take immediate corrective action if it believes (or has reason to believe) that a product placed on the market does not comply with Regulation No. 481/2012 Coll.;

9. cooperate with market surveillance authorities and, upon request, provide them with documentation and other information.

If other relevant Union legislation requires the application of a conformity assessment procedure that is at least as stringent, the conformity assessment may be carried out within the framework of those procedures, and a single set of technical documentation may be prepared.

The Electrotechnical Testing Institute, in cooperation with the Ministry of Industry and Trade, has prepared a MANUAL FOR GOVERNMENT REGULATION No. 481/2012 Coll., ON THE RESTRICTION OF THE USE OF CERTAIN HAZARDOUS SUBSTANCES IN ELECTRICAL AND ELECTRONIC EQUIPMENT – “RoHS,” which is also available on the MIT website. An updated version has been available since April 2019: Manual to the Government Regulation on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment – RoHS. The MPO website also features a notice for manufacturers, authorized representatives of manufacturers, importers, and distributors of electrical equipment. As of July 22, 2019, the list of restricted substances and the range of electrical equipment not previously covered by RoHS rules will be expanded

Standards for the Assessment of Hazardous Substances in Electrical and Electronic Equipment

Standard	Standard Title
ČSN EN 50581:2013 Amendment Z1:2019 Withdrawn on December 7, 2023, and replaced by ČSN EN IEC 63000:2019	Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances (Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances) preview (36 9083) (cs)
ČSN EN IEC 63000:2019	Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances (cs) (36 9083)
IEC TR 62476:2010	Guidance for the evaluation of products with respect to restrictions on the use of substances in electrical and electronic products
IEC/PAS 62596:2009 has been withdrawn and partially replaced by: IEC 62321-2:2013 withdrawn and IEC 62321-3-1:2013	Electrotechnical products - Determination of restricted substances - Sampling procedure - Guidelines
ČSN EN 62321:2009 Amendment 1:2014 Amendment 2:2014 Amendment 3:2016 Amendment 4:2020 Standard withdrawn on May 2, 2020	Electrotechnical products - Determination of levels of six restricted substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) (cs) (36 9080) (Electrotechnical products - Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers))
IECQ 080000-EN:2017	IEC Quality Assessment System for Electronic Components (IECQ System) - Hazardous Substance Process Management (HSPM) System Requirements
IEC 62321-1:2013	ČSN EN 62321-1:2014 (cs) (36 9080) preview Determination of certain substances in electrotechnical products - Part 1: Introduction and overview / IEC 62321-1:2013
IEC 62321-2:2013 Withdrawn and replaced by: IEC 62321-2:2021	ČSN EN 62321-2:2014 (36 9080) (cs) Determination of certain substances in electrotechnical products - Part 2: Disassembly, disjointment and mechanical sample preparation preview Determination of certain substances in electrotechnical products - Part 2: Disassembly, disjointment and mechanical sample preparation
IEC 62321-2:2021	Determination of certain substances in electrotechnical products - Part 2: Disassembly, disjointment and mechanical sample preparation
IEC 62321-3-1:2013	ČSN EN 62321-3-1:2014 (36 9080) (cs) preview Determination of certain substances in electrotechnical products - Part 3-1: Screening - Lead, mercury, cadmium, total chromium, and total bromine using X-ray fluorescence spectrometry)
IEC 62321-3-2:2013 Withdrawn and replaced by: IEC 62321-3-2:2020 RLV	ČSN EN 62321-3-2:2014 (36 9080) (cs) preview Determination of certain substances in electrotechnical products - Part 3-2: Screening - Total bromine in polymers and electronics by combustion-ion chromatography (Determination of certain substances in electrotechnical products - 3-2: Screening - Total bromine in polymers and electronics by Combustion - Ion Chromatography)
IEC 62321-3-2:2020 RLV	Determination of certain substances in electrotechnical products - Part 3-2: Screening - Fluorine, bromine, and chlorine in polymers and electronics by combustion-ion chromatography (C-IC)
IEC 62321-4:2013+AMD1: 2017 CSV	ČSN EN 62321-4:2014 (36 9080) (cs) preview Determination of certain substances in electrotechnical products - Part 4: Mercury in polymers, metals, and electronics by CV-AAS, CV-AFS, ICP-OES, and ICP-MS (Determination of certain substances in electrotechnical products - Part 4: Mercury in polymers, metals, and electronics by CV-AAS, CV-AFS, ICP-OES, and ICP-MS)
IEC 62321-5:2013	ČSN EN 62321-5:2014 (36 9080) (cs) preview Determination of certain substances in electrotechnical products - Part 5: Cadmium, lead, and chromium in polymers and electronics and cadmium and lead in metals by AAS, AFS, ICP-OES, and ICP-MS (Determination of certain substances in electrotechnical products - Part 5: Cadmium, lead, and chromium in polymers and electronics, and cadmium and lead in metals by AAS, AFS, ICP-OES, and ICP-MS)
IEC 62321-6:2015	ČSN EN 62321-6:2016 (36 9080) (cs) preview Determination of certain substances in electrotechnical products - Part 6: Polybrominated biphenyls and polybrominated diphenyl ethers in polymers by gas chromatography-mass spectrometry (GC-MS) (Determination of certain substances in electrotechnical products - Part 6: Polybrominated biphenyls and polybrominated diphenyl ethers in polymers by gas chromatography-mass spectrometry (GC-MS))
IEC 62321-7-1:2015	ČSN EN 62321-7-1:2016 (36 9080) (cs) preview Determination of certain substances in electrotechnical products - Part 7-1: Hexavalent chromium - Presence of hexavalent chromium (Cr(VI)) in colourless and coloured corrosion-protected coatings on metals by colorimetric method (Determination of certain substances in electrotechnical products - Part 7-1: Hexavalent chromium - Presence of hexavalent chromium (Cr(VI)) in colourless and coloured corrosion-protected coatings on metals by the colorimetric method)
IEC 62321-7-2:2017	ČSN EN 62321-7-2:2017 (36 9080) (cs) preview Determination of certain substances in electrotechnical products - Part 7-2: Hexavalent chromium - Determination of hexavalent chromium (Cr(VI)) in polymers and electronics by the colorimetric method
IEC 62321-8:2017	ČSN EN 62321-8:2018 (36 9080) (en) Determination of certain substances in electrotechnical products - Part 8: Phthalates in polymers by gas chromatography-mass spectrometry (GC-MS) and pyrolysis/thermal desorption-gas chromatography-mass spectrometry (Py/TD-GC-MS) (Determination of certain substances in electrotechnical products - Part 8: Phthalates in polymers by gas chromatography-mass spectrometry (GC-MS), gas chromatography-mass spectrometry using a pyrolyzer/thermal desorption accessory (Py/TD-GC-MS))
IEC 62430:2019	Environmental Conscious Design (ECD) - Principles, requirements, and guidance
IEC 62474:2018+AMD1:2020 CSV	Material declaration for products of and for the electrotechnical industry
IEC TR 62824:2016	Guidance on material efficiency considerations in environmentally conscious design of electrical and electronic products
IEC 62321-7-2:2017	Determination of certain substances in electrotechnical products - Part 7-2: Determination of hexavalent chromium (Cr(VI)) in polymers and electronics by the colorimetric method.
IEC 62321-8:2017	Determination of certain substances in electrotechnical products - Part 8: Determination of specific phthalates in polymer materials by mass spectrometry
IEC 62321-9:2021	Determination of certain substances in electrotechnical products - Part 9: Hexabromocyclododecane in polymers by chromatography-mass spectrometry (GC-MS)
IEC 62321-10:2020	Determination of certain substances in electrotechnical products - Part 10: Polycyclic aromatic hydrocarbons (PAHs) in polymers and electronics by gas chromatography-mass spectrometry (GC-MS)
IEC 62321-3-3:2021	Determination of certain substances in electrotechnical products - Part 3-3: Screening - Polybrominated biphenyls, polybrominated diphenyl ethers, and phthalates in polymers by gas chromatography-mass spectrometry using a pyrolyzer/thermal desorption accessory (Py/TD-GC-MS)
IEC 63000:2016+AMD1:2022 CSV	Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances // ČSN EN IEC 63000:2019 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances (cs) (36 9083)
IEC TR 62936:2016	Test Method Development - Guide for Substance Selection