1. Introduction: Importance of REACH and RoHS standards for industrial enterprises

In modern industrial production, ensuring product safety and environmental protection is an integral part of operational activities. The REACH Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) and the RoHS Directive (Restriction of Hazardous Substances) are key European regulations that set strict requirements for chemicals and materials used in the production and import of goods.

For Ukrainian industrial enterprises seeking integration into world markets and maintaining high quality standards, understanding and complying with these regulations is critically important. Non-compliance can lead not only to significant financial losses, but also to reputational risks, refusal to admit products to EU markets and internal fines. Ensuring that spare parts meet these standards is fundamental to the reliable and safe operation of the equipment, as well as to minimizing the negative impact on the health of personnel and the environment.

2. Scope and compliance

The REACH Regulation (Regulation (EC) No. 1907/2006) deals with the registration, evaluation, authorization and restriction of chemicals. It applies to all chemicals produced or imported into the EU in quantities of more than 1 tonne per year, whether in their pure form or in mixtures or articles. This means that any component or material supplied for Ukrainian production that contains chemicals must comply with REACH if it is intended for export to the EU or if the supplier is located in the EU.

The RoHS Directive (Directive 2011/65/EU) restricts the use of certain hazardous substances in electrical and electronic equipment (EEE). It is applied to a wide range of products, including industrial equipment, automation systems, control and measuring devices and their spare parts. Restricted substances include lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr(VI)), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and four phthalates: bis(2-ethylhexyl) phthalate (DEHP), butylbenzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP).

2.1. Who must comply?

• Manufacturers: Enterprises producing industrial equipment and components.
• Importers: Companies importing products from outside the EU, including spare parts.
• Distributors: Suppliers distributing products on the market.
• Operators of industrial plants: To ensure compliance of the equipment in operation and its spare parts.

2.2. Equipment and industries

REACH and RoHS requirements apply to a wide range of industrial equipment and spare parts, including:

• Electric motors and drives.
• Controllers, sensors, encoders.
• Printed circuit boards and electronic components.
• Cables and wires.
• Hydraulic and pneumatic components (valves, cylinders, seals).
• Pumps, compressors, reducers.
• Bearings and transmission elements.
• Lubricants, sealants, glues.

These norms are mandatory for all branches of industrial production in Ukraine, especially those that use EEE and chemicals, including mechanical engineering, metallurgy, energy, chemical industry, food industry and water treatment.

3. Key requirements and limitations

3.1. RoHS restricted substances

The RoHS Directive establishes maximum permissible concentrations (MELs) for restricted substances in homogeneous materials:

These limitations apply to each homogeneous part of the product, which is critical for the selection of spare parts.

3.2. The main requirements of REACH

• Registration: Manufacturers and importers of chemicals in quantities of more than 1 ton per year must register them with the European Chemicals Agency (ECHA).
• Authorization: Substances of Very High Concern (SVHC) may require authorization for use. The SVHC list is regularly updated.
• Restrictions: Some substances may be completely prohibited or restricted in certain applications.
• Information about SVHC: Suppliers of products containing SVHC in a concentration of more than 0.1% by weight must inform their customers about this.

4. Impact on MRO (Maintenance, Repair, and Operations) operations

Compliance with REACH and RoHS significantly changes the approach to maintenance, repair and operation (MRO) in industrial enterprises.

4.1. Purchase of spare parts

• Vendor Verification: Strict vendor verification procedures must be implemented to ensure that they provide certified and compliant components. UNITEC-D GmbH, as a supplier, ensures product compliance with CE and UkrSEPRO requirements, as well as REACH and RoHS.
• Material declarations: Require from suppliers declarations of conformity, technical documentation with information on the composition of materials and the absence of prohibited substances.
• Long-term contracts: Enter into long-term contracts with reliable suppliers that guarantee continuous compliance.

4.2. Inventory management

• Identification: Clear labeling and identification of compliant and non-compliant components in stock.
• Segregation: The physical separation of compliant from non-compliant spare parts, if still in use for old equipment not covered by the directives.
• Obsolescence control: Tracking of changes in the lists of prohibited substances and timely updating of the nomenclature of spare parts.

4.3. Documentation and reporting

• Technical documentation: Keeping a complete set of technical documentation confirming the conformity of all components, including certificates, test results and supplier declarations. This may include compliance with EN IEC 63000:2018 (formerly EN 50581:2012) for RoHS.
• Traceability: Implementation of traceability systems for each batch of spare parts, allowing to track their origin and compliance.
• Regular audits: Conduct internal audits to verify compliance with MRO requirements.

5. Requirements for components and spare parts

Every component that is part of a final product subject to RoHS or contains chemicals subject to REACH must be checked for compliance. This includes:

• Electronic components: Resistors, capacitors, integrated circuits, LEDs. They must be lead-free and contain no other prohibited substances.
• Cables and Connectors: Cable insulation, braiding, solder and connector contacts must be RoHS compliant. For example, cables must meet the material requirements of EN 50525.
• Seals and gaskets: Materials such as rubber, plastic, composites used in seals for pumps, valves or hydraulic systems must not contain banned phthalates (DEHP, BBP, DBP, DIBP) or other SVHCs. The operating temperature for such materials, e.g. EPDM, in the range of -40°C to +120°C must be maintained without degradation of the material, which may release undesirable substances.
• Metal parts: Coatings such as galvanizing, chromating, or nickel plating used to protect metal bodies or fasteners must not contain hexavalent chromium. For example, metal fasteners used in assemblies must have a surface finish that complies with ISO 4042.
• Lubricants and fluids: Industrial lubricants, hydraulic fluids, coolants must comply with REACH registration and SVHC-free requirements. The operating temperature range, for example, of hydraulic fluid from -20°C to +80°C under pressure up to 250 bar, must be compatible with environmental standards.
• Sensors and transducers: Housings, printed circuit boards and connecting elements of pressure, temperature, position sensors must be RoHS-compliant.

UNITEC-D GmbH offers a wide range of certified spare parts that meet both European (CE, REACH, RoHS) and national (UkrSEPRO) standards, ensuring reliability and safety for your production processes.

6. Compliance Checklist for Maintenance Managers

This checklist will help ensure consistent REACH and RoHS compliance in your MRO operations:

1. Develop and implement a procurement policy requiring REACH and RoHS compliance for all new spare parts.
2. Include REACH and RoHS requirements in contracts with suppliers.
3. Introduce a procedure for checking new suppliers for their ability to provide appropriate products.
4. Require suppliers to provide declarations of conformity (DoC) and technical documentation for each batch of spare parts.
5. Check for CE and/or UkrSEPRO marking on products where applicable as proof of compliance.
6. Create a database or registry of all spare parts containing information on their REACH and RoHS compliance.
7. Check regularly for updates to the SVHC (Substances of Very High Concern) list from ECHA.
8. Check for updates to the RoHS Directive and its annexes.
9. Train procurement staff, engineers and maintenance technicians on REACH and RoHS requirements.
10. Ensure proper storage of compliance documentation for the statutory period (usually 10 years).
11. Implement a system of control of incoming materials for selective inspection of components for the presence of prohibited substances.
12. Develop an action plan if non-conforming components are identified (eg, isolation, return, disposal).
13. Conduct regular internal audits to assess the effectiveness of the compliance management system.
14. Consider the possibility of certification of the environmental management system according to ISO 14001.
15. Ensure that any equipment being repaired or upgraded is fitted with only suitable components.
16. Check that seals and gaskets used in hydraulic systems are phthalate-free, especially when operating at pressures up to 300 bar.
17. Ensure that power cables operating at 400V are RoHS compliant for insulating materials.
18. Check whether lubricants for gearboxes with a capacity of up to 500 kW have relevant safety data sheets and REACH registration.
19. Control that electronic boards in control systems operating at temperatures up to 70°C are made of RoHS-compliant materials.
20. Create communication channels with suppliers to quickly obtain up-to-date information about product composition.

7. Common inconsistency problems

Auditors often detect the following violations:

• Lack of proper documentation: Incomplete or missing declarations of conformity, technical files, test results.
• Insufficient verification of suppliers: Purchasing components without proper assessment of their conformity, resulting in non-certified products.
• Incorrect marking: Absence of CE or UkrSEPRO marking, or its incorrect application.
• Inadvertent Use of Prohibited Substances: Detection of traces of lead in solders or cadmium in plastic components that have been declared compliant.
• Lack of internal procedures: Undeveloped policies and procedures to manage REACH and RoHS compliance at MRO.
• Insufficient staff training: Staff are not familiar with the requirements and cannot identify non-compliant products.
• Ignoring SVHC in products: Failure to provide information on the presence of SVHC in a concentration of more than 0.1% in products, which is a requirement of REACH.

8. Penalties and liability

Failure to comply with the REACH and RoHS regulations can have significant legal and financial consequences for Ukrainian enterprises, especially those that export products to the EU or work with European partners.

• Financial penalties: In the EU, fines for REACH and RoHS violations can reach tens of thousands of euros, and in some cases - millions of euros, depending on the severity and scale of the violation. In Ukraine, the legislation provides for administrative liability for violation of product safety requirements, which may include fines in the amount of hundreds of thousands of hryvnias for putting non-compliant products into circulation, according to the Code of Ukraine on Administrative Offenses.
• Recall of products: In case of non-compliance, products may be recalled from the market, which entails huge logistical and reputational costs.
• Import/Export Ban: Companies may be prohibited from importing or exporting non-compliant products, paralyzing international trade.
• Reputational damages: Public disclosure of non-compliance can seriously undermine the trust of customers and partners, resulting in a loss of market share.
• Civil liability: The enterprise may be held civilly liable for damage caused to the health of consumers or the environment due to the use of hazardous substances.
• Responsibility of management: Company managers may be held personally administratively or even criminally liable for systematic violations of environmental legislation or product safety legislation.
• Insurance issues: Insurance companies may deny coverage for non-conformance losses if due diligence was not followed.

9. Conclusion

Compliance with the REACH and RoHS regulations is not just a legal requirement, but a strategic imperative for a modern industrial enterprise. This not only provides access to international markets, but also increases environmental responsibility, occupational safety and operational reliability. A systematic approach to supplier selection, thorough component testing and documentation are fundamental to the successful integration of these standards into MRO processes.

UNITEC-D GmbH is a reliable partner that understands these challenges. We offer a wide range of industrial spare parts that meet the strictest international standards, including REACH, RoHS, as well as CE and UkrSEPRO certifications. Our components undergo strict quality control, ensuring long-term reliability and full compliance with regulatory requirements for your production.

For detailed information on certified components and support in ensuring your equipment is compliant, visit the UNITEC-D E-Catalog.

10. Links

• Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of December 18, 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
• Directive 2011/65/EU of the European Parliament and of the Council of June 8, 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast).
• EN IEC 63000:2018 (BS EN IEC 63000:2019) – Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.
• ISO 14001:2015 - Environmental management systems - Requirements with guidance for use.
• DSTU EN ISO 14001:2015 – Environmental management systems. Application requirements and guidelines (EN ISO 14001:2015, IDT).
• Code of Ukraine on administrative offenses.

Introduction: Importance of standards for industrial operations in Ukraine

In the modern industrial sector, especially in the context of Ukraine's integration into the European economic space, compliance with international standards is not only desirable, but critically important. REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) regulations play a central role in ensuring environmental safety, protecting the health of workers and consumers, as well as in maintaining the stability of production chains. These norms directly affect maintenance, repair and operation (MRO) processes at Ukrainian industrial enterprises.

As the chief engineer of UNITEC-D GmbH, with more than 20 years of workshop experience and 10 years of design experience, I emphasize that ignoring these requirements can lead to significant operational risks, financial losses and limited access to international markets. A proper understanding and application of REACH and RoHS in the procurement and use of industrial spare parts is the basis for the reliable and safe operation of any manufacturing facility.

Scope and Compliance: Who, What, and Where?

REACH Regulation (Regulation (EC) No 1907/2006)

The REACH regulation, which entered into force on June 1, 2007, is one of the most comprehensive legislative acts of the European Union in the field of chemicals. Its main objective is to improve the protection of human health and the environment from the risks associated with chemicals, while contributing to the competitiveness of the EU chemical industry. It deals with the registration, evaluation, authorization and restriction of chemicals.

• Who must comply: Any company that manufactures or imports chemicals into the EU in quantities of 1 tonne or more per year. This also includes manufacturers and importers of "articles" (finished goods such as machines, appliances, components) if they contain "substances of very high concern" (SVHCs) at a concentration of more than 0.1% by weight (w/w) and in a total quantity of more than 1 tonne per year.
• What equipment/components: All industrial chemicals (lubricants, coolants, sealants, adhesives, paints, solvents, detergents). Also, a significant proportion of spare parts which are "products" and may contain SVHCs. Examples are seals containing phthalates or bearings with special coatings that may contain heavy metals.
• Which industries: Virtually all industries that use chemicals or import products containing them, including engineering, metalworking, energy, food, chemical.

RoHS Directive (Directive 2011/65/EU and Directive (EU) 2015/863)

The RoHS Directive, known as RoHS 2 (2011/65/EU) and later expanded to RoHS 3 (2015/863), restricts the use of certain hazardous substances in electrical and electronic equipment (EEE). Its purpose is to reduce the risks to human health and the environment associated with the disposal of EEE.

• Who must comply: Manufacturers, importers and distributors of EEE. For Ukrainian enterprises, this is critical when exporting products to the EU or using components from the EU subject to this directive.
• What equipment/components: Electrical and electronic equipment, including industrial monitoring and control devices, power tools, automatic dispensers. Many industrial spare parts such as electronic boards, cables, connectors, sensors, motors, actuators, relays, switches, LED indicators must be RoHS compliant.
• Which industries: Any industry that produces, imports or uses EEE, including engineering, automation, energy, telecommunications.

Key requirements and deadlines

Compliance with REACH and RoHS requires a systematic approach. Below is a summarized table of main liabilities.

Impact on MRO operations

The introduction and compliance of REACH and RoHS regulations significantly changes approaches to MRO management. These changes apply to the procurement, storage, use and disposal of spare parts and materials.

Purchase of spare parts

• Vendor Verification:Vendors are required to be thoroughly vetted for their ability to provide certified and compliant products. Suppliers must provide declarations of conformity (DoC) according to ISO/IEC 17050-1:2004 (or national equivalent DSTU ISO/IEC 17050-1:2014) and technical documentation.
• Materials specification: REACH and RoHS compliance requirements must be clearly specified when ordering spare parts. This may include requesting materials that are phthalate-free, lead-free, or low in other restricted substances.
• Certification: Priority is given to components with CE marking and, where possible, with UkrSEPRO certification, which confirms compliance with Ukrainian technical regulations, which are often harmonized with European directives.

Maintenance and repair

• Safe Handling: MRO personnel must be trained in the safe handling of chemicals and components potentially containing restricted substances. This includes using appropriate personal protective equipment (PPE) and following the procedures described in the SDS.
• Replacement of components: When replacing, only suitable spare parts must be used. Use of non-certified or non-compliant components, even if they are functionally identical, may result in violations and legal consequences.

Documentation and accounting

• Document Retention: Accurate records of all Declarations of Conformity, Safety Data Sheets and Certificates for each batch of spare parts are required. These documents must be available for audit for a minimum of 10 years after the last placement of the product on the market.
• Internal procedures: Development and implementation of internal MRO procedures, including verification of REACH and RoHS compliance at all stages of the life cycle of spare parts.

Requirements for components and spare parts

Not all spare parts are subject to the same requirements, but a large number of them need to be checked for compliance.

Components requiring REACH compliance

• Chemical products: Lubricants for bearings and gearboxes, hydraulic fluids, anti-corrosion coatings, adhesives for fixation, sealants for seals, solvents for cleaning equipment, industrial paints. These products must have up-to-date Safety Data Sheets (SDS) and be registered if they are manufactured/imported in significant quantities.
• Products containing SVHCs: Some seals (eg with certain polymers containing phthalates), cables with certain plasticizers, components with coatings containing heavy metals. The supplier must provide information if the SVHC content exceeds 0.1% w/w.

Components requiring RoHS compliance

• Electronic components: Resistors, capacitors, diodes, transistors, integrated circuits, microcontrollers.
• Electrical components: Relays, switches, buttons, connectors, terminals, cables and wires, fuses.
• Mechanical components with electrical function: Sensors (temperature, pressure, position), encoders, electric motors, solenoid valves, LED indicators.
• Enclosures and Coatings: Components of electronic equipment enclosures that may contain restricted substances (such as cadmium in certain plastics or lead in solders).

All these components must have a RoHS declaration of conformity, and for the EU market - CE marking. For Ukraine, in addition, UkrSEPRO certification may be required, which confirms compliance with the Technical Regulations of Ukraine, which are often based on European directives.

Compliance Checklist for Maintenance Managers

This practical checklist will help ensure your company's REACH and RoHS compliance:

1. Conduct an inventory of all chemicals and spare parts used.
2. Determine which materials and components are subject to REACH and RoHS.
3. Ensure the availability of up-to-date Safety Data Sheets (SDS) for all chemicals.
4. Require REACH and RoHS Declaration of Conformity (DoC) from suppliers for relevant spare parts.
5. Check for CE marking on imported electrical and electronic components.
6. Check the availability of UkrSEPRO certificates, if required for the domestic market.
7. Create a database or registry to track the compliance status of all components.
8. Develop internal procedures for procurement and acceptance of relevant materials.
9. Train MRO staff on REACH/RoHS requirements and safe material handling procedures.
10. Develop protocols for safe handling and disposal of spent chemicals and components.
11. Regularly review SVHC lists and REACH Annexes XVII/XIV, as well as changes to RoHS.
12. Audit existing inventory for compliance.
13. Implement a risk management system related to chemical substances.
14. Ensure traceability of components from purchase to installation and disposal.
15. Designate a responsible person or team for compliance with these regulations.
16. Regularly conduct internal audits of the compliance system.
17. Ensure interaction with regulatory bodies and experts in case of doubt.
18. Integrate compliance requirements into the quality management system (eg ISO 9001).
19. Identify alternative, environmentally safer materials and components.
20. Maintain contact with associations and industry associations to share experience.

Mismatch issues are common

Our experience shows that businesses often face similar challenges when trying to comply with REACH and RoHS:

• Insufficient documentation: Missing or incomplete declarations of conformity, outdated SDS, missing technical files. This is often due to the difficulty of tracking the supply chain.
• Negligent verification of suppliers: Purchasing components from unverified suppliers who cannot provide the necessary certificates or information about the composition of the products.
• Unawareness of SVHCs in products: Businesses are not always aware that even "simple" mechanical spare parts may contain SVHCs that require reporting.
• Improper disposal: Waste containing restricted substances is disposed of as normal industrial waste, resulting in pollution and disturbances.
• Using "gray" spare parts: Buying cheap non-genuine components without proper verification of conformity, which can lead to systemic risks.
• Outdated internal procedures: MRO processes are not updated to meet the new regulatory requirements, resulting in the use of inappropriate materials.
• Lack of staff training: Employees are unaware of the requirements, risks, and proper procedures for handling hazardous substances.

Penalties and liability

Non-compliance with the REACH and RoHS regulations can have serious consequences for Ukrainian industrial enterprises, especially those that work for export or use imported components.

• Financial penalties: In the EU, fines for REACH violations can reach hundreds of thousands or even millions of euros, depending on the severity and scale of the violation. Ukrainian legislation, harmonized with European legislation, also provides for significant administrative fines for violations of technical regulations and environmental legislation. For example, fines in the amount of tens of thousands of hryvnias can be applied to officials for violating the rules of handling hazardous waste, and up to hundreds of thousands for violating environmental legislation.
• Product recalls: Non-conforming products may be recalled from the market, causing huge financial and reputational losses.
• Restrictions on access to markets: Companies that do not comply with these regulations may lose the opportunity to export their products to the EU and other countries that require compliance.
• Legal responsibility: The management and the enterprise may be held legally responsible for damage caused to the health of employees, consumers or the environment due to the use of hazardous substances. This may include legal action and compensation payments.
• Reputational damages: Public announcements of non-compliance can significantly undermine the trust of customers, partners and investors, which is a difficult asset to restore.
• Supply chain disruptions: Refusal of suppliers to provide compliant components or refusal of customers to accept non-compliant products can lead to major disruptions in production processes.

Conclusion

Ensuring compliance with REACH and RoHS regulations is an integral part of modern industrial activity, especially for enterprises seeking stability, competitiveness and integration into international markets. This requires not only knowledge, but also a systematic approach to MRO management, starting with thorough vetting of suppliers and ending with proper disposal.

UNITEC-D GmbH, as a global authority in MRO, understands these challenges. We offer a wide range of industrial spare parts that meet the strictest international standards, including REACH and RoHS. Our products are certified, reliable and designed to keep your equipment running smoothly and safely.

For more information and a selection of certified, compliant components, visit the UNITEC-D E-Catalog.

Link

• Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
• Directive 2011/65/EU of the European Parliament and the Council of June 8, 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2).
• Commission Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council on the list of restricted substances (RoHS 3).
• DSTU EN 50581:2016. Technical documentation for the assessment of electrical and electronic products regarding the restriction of the use of hazardous substances.
• DSTU ISO/IEC 17050-1:2014. Compliance assessment. Supplier Declaration of Conformity. Part 1. General requirements.