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.
| Regulations | Basic requirements | Limit values / Deadlines |
|---|---|---|
| REACH | Registration: For substances produced/imported >1 ton/year. | Depends on the volume: 1-100 tons/year until 31.05.2018 (for existing ones), SVHC in products >0.1% w/w – obligation to inform. |
| Safety Data Sheets (SDS): For hazardous substances and mixtures. | Mandatory for all hazardous substances according to Regulation (EC) No. 1272/2008 (CLP). | |
| Authorization: For use by SVHCs. | After the inclusion of a substance in Annex XIV of REACH. | |
| Restrictions: Prohibition or restriction of production/use of certain substances. | According to REACH Annex XVII. | |
| RoHS | Substance restrictions: Lead (Pb), Cadmium (Cd), Mercury (Hg), Hexavalent chromium (Cr(VI)), Polybrominated biphenyls (PBB), Polybrominated diphenyl ethers (PBDE), Bis(2-ethylhexyl) phthalate (DEHP), Butylbenzyl phthalate (BBP), Dibutyl phthalate (DBP), Diisobutyl phthalate (DIBP). | Maximum concentration in homogeneous material:
DEHP, BBP, DBP, DIBP - from 22.07.2019 for most EEE. |
| Technical documentation: Compliance demonstration. | According to EN 50581 (DSTU EN 50581:2016). | |
| CE marking: For conforming products. | Mandatory for entering the EU market. |
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:
- Conduct an inventory of all chemicals and spare parts used.
- Determine which materials and components are subject to REACH and RoHS.
- Ensure the availability of up-to-date Safety Data Sheets (SDS) for all chemicals.
- Require REACH and RoHS Declaration of Conformity (DoC) from suppliers for relevant spare parts.
- Check for CE marking on imported electrical and electronic components.
- Check the availability of UkrSEPRO certificates, if required for the domestic market.
- Create a database or registry to track the compliance status of all components.
- Develop internal procedures for procurement and acceptance of relevant materials.
- Train MRO staff on REACH/RoHS requirements and safe material handling procedures.
- Develop protocols for safe handling and disposal of spent chemicals and components.
- Regularly review SVHC lists and REACH Annexes XVII/XIV, as well as changes to RoHS.
- Audit existing inventory for compliance.
- Implement a risk management system related to chemical substances.
- Ensure traceability of components from purchase to installation and disposal.
- Designate a responsible person or team for compliance with these regulations.
- Regularly conduct internal audits of the compliance system.
- Ensure interaction with regulatory bodies and experts in case of doubt.
- Integrate compliance requirements into the quality management system (eg ISO 9001).
- Identify alternative, environmentally safer materials and components.
- 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.