REACH and RoHS Compliance in the Acquisition of Industrial Spare Parts: A Practical Guide for Brazilian Manufacturing

1. Introduction: The Essentiality of Compliance in MRO

Maintenance, Repair and Operations (MRO) management in modern industry requires rigorous attention to compliance with international regulations. Although the REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) directives originate from the European Union, their impact transcends borders, directly affecting the global supply chain, including Brazilian manufacturing. Purchasing non-conforming spare parts can generate significant risks, from operational disruptions and financial fines to damage to reputation and worker health.

This technical article addresses the relevance of REACH and RoHS for MRO operations in Brazil, highlighting the need for a proactive approach in selecting and purchasing components. Compliance guarantees not only access to international markets, but also the safety of the working environment and the sustainability of operations, aligning with the best management practices and national standards such as those of ABNT and regulatory authorities (NRs).

2. Scope and Applicability: Who and what is Covered?

The applicability of REACH and RoHS in the Brazilian context is multifaceted, influenced by the origin of the components, the destination of the manufactured products and internal safety and environmental requirements.

2.1. REACH Regulation (EC) No 1907/2006

REACH regulates the registration, evaluation, authorization and restriction of chemical substances. For Brazilian industry, this means that:

• Importers and Distributors: Must ensure that chemical substances (pure or in mixtures) and articles imported from the EU or from suppliers that follow the REACH standard are compliant. This includes lubricants, adhesives, paints, solvents, sealants and even certain plastic or metal components with surface treatments.
• Article Manufacturers: Companies exporting manufactured products to the EU must ensure that articles (parts or final products) do not contain Substances of Very High Concern (SVHCs) above permitted limits (generally 0.1% by weight), unless duly authorized or communicated.
• Occupational Safety: Information about SVHCs and other dangerous substances must be communicated throughout the supply chain through Safety Data Sheets (SDS) in accordance with ABNT NBR 14725, ensuring the safety of MRO workers, as required by NRs 09 and 15.

2.2. RoHS Directive 2011/65/EU (Recast)

RoHS restricts the use of ten hazardous substances in electrical and electronic equipment (EEE). For Brazil, the directive is crucial for:

• Import of EEE and Spare Parts: All imported electronic and electrical components, such as printed circuit boards (PCBs), cables, connectors, sensors, relays, motors with integrated electronic components, displays and power supplies, must comply with concentration limits.
• Restricted Substances: The maximum concentration limits by weight of homogeneous materials are: Lead (Pb), Mercury (Hg), Hexavalent Chromium (Cr VI), Polybrominated Biphenyls (PBB), Polybrominated Diphenyl Ethers (PBDE), Di(2-ethylhexyl)phthalate (DEHP), Butylbenzylphthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP) at 0.1% (1000 ppm); Cadmium (Cd) at 0.01% (100 ppm).
• Global Market: Even if a final product is not exported to the EU, the adoption of RoHS-compliant components minimizes environmental and health risks, in addition to positioning the company competitively on the global stage.

Sectors such as electronics, automotive, industrial machinery, energy and automation are particularly impacted. Any manufacturing plant that uses EEE or chemical substances in its processes or in its machines must consider these regulations.

3. Key Requirements and Obligations

REACH and RoHS compliance requires a clear understanding of the requirements and implementation of appropriate processes. The following table summarizes the main obligations:

4. Impact on MRO Operations

Integrating REACH and RoHS into MRO operations requires a strategic review of processes and policies:

• Acquisition and Supplies: The purchasing sector must prioritize suppliers that prove the conformity of their products. This includes the requirement for declarations of conformity, updated SDS (according to ABNT NBR 14725), and, for EEE, CE certification. UNITEC-D, for example, acts as a reliable partner, providing certified components with transparent documentation.
• Inventory Management: It is essential to segregate compliant and non-compliant parts, especially for legacy equipment. Clear labeling and traceability systems are essential to prevent misuse of materials.
• Maintenance and Repair: Maintenance teams must be trained to correctly identify and handle components, especially when it comes to lead-free solders or specific chemical substances. NR-10 and NR-12, together with NR-09, guide safe practices.
• Documentation and Traceability: Maintaining a complete record of all declarations of conformity, certificates and SDS for each spare part is critical. This documentation serves as evidence in audits and in the event of incidents.
• Costs: Although compliant parts may have a marginally higher initial cost, the investment is justified by the reduced risk of fines, recalls, production interruptions and health damage, resulting in long-term savings.

5. Component Requirements and Certifications

Conformity is not an abstract concept; it manifests itself in the technical specifications and certifications of the components:

• Electronic Components: Circuit boards, capacitors, resistors, semiconductors, connectors and cables must be RoHS-compliant. This involves the use of lead-free solder (usually tin alloys with silver and copper) and insulation materials that do not contain the restricted substances. Many of these components must also meet INMETRO electrical safety requirements, such as Ordinances No. 328/2011 and No. 327/2011 for electrical and electronic equipment, ensuring that electrical safety and material composition go hand in hand.
• Mechanical Parts with Surface Treatment: Components such as screws, nuts, supports and metal housings may contain hexavalent chromium in anti-corrosive coatings. The search for alternatives such as zinc-nickel or trivalent passivations is critical for REACH and RoHS compliance.
• Polymers and Plastics: Machine housings, insulation and sealants may contain phthalates (DEHP, BBP, DBP, DIBP) or brominated flame retardants (PBB, PBDE). Specification of polymers without these substances is crucial.
• Lubricants, Adhesives and Sealants: These chemicals must have SDS that demonstrate the absence of SVHCs above limits or that indicate their REACH registration, if applicable. Compliance with ABNT NBR 14725 for the FDS is a legal requirement in Brazil.
• Motors and Drives: Although predominantly mechanical, modern motors and their drives often contain integrated electronic components (sensors, PCBs) that must be RoHS-compliant. Compliance with NR-12 for machine safety and NR-10 for electrical installations requires that the components used do not compromise the intrinsic safety of the equipment due to dangerous substances.

Checking certifications such as CE Mark (for products imported from the EU), manufacturer declarations of conformity, laboratory test reports and updated SDS are essential tools to validate component compliance.

6. Compliance Checklist for Maintenance Managers

An effective compliance program requires a structured action plan. This practical checklist helps maintenance managers and security teams:

1. Component Inventory: Identify all electrical, electronic and chemical spare parts used in the plant.
2. Supplier Assessment: Review and qualify suppliers based on their ability to provide compliant products and supporting documentation.
3. Documentation Request: Require RoHS compliance declarations, SVHCs (REACH) declarations, and updated Safety Data Sheets (FDS), in accordance with ABNT NBR 14725, for all relevant products.
4. CE Marking Verification: For EEE imported from the EU, check the presence and validity of the CE marking.
5. Staff Training: Train procurement, inventory and maintenance teams on REACH and RoHS requirements, and the safe handling of materials.
6. Traceability System: Implement a system to track the conformity of each batch of spare parts received.
7. Inventory Segregation: Maintain separate inventory for nonconforming legacy parts, if still in use, and for new conforming parts.
8. Internal Audits: Carry out periodic audits to verify adherence to compliance procedures.
9. Restriction List Monitoring: Monitor updates to the ECHA list of SVHCs and RoHS restricted substances.
10. Purchase Specifications: Include REACH and RoHS compliance clauses in all purchase orders and supplier contracts.
11. Risk Analysis: Assess the risk of non-compliance for critical or high-volume components.
12. Proper Disposal: Establish procedures for the disposal of non-compliant parts and substances, in alignment with the National Solid Waste Policy (Law nº 12,305/2010).
13. Interdepartmental Collaboration: Work closely with Engineering, Quality, and R&D departments to ensure new designs and modifications incorporate compliance requirements.
14. Chemical Review: Assess all chemicals in use to identify those that may contain SVHCs or restricted substances.
15. Contingency Plan: Develop a plan in case non-conforming parts already in use or stock are identified.

7. Common Non-Compliance Issues

Experience in industrial audits reveals patterns of non-compliance that can be avoided with diligence:

• Incomplete or Missing Documentation: The lack of declarations of conformity, outdated or non-existent SDS is one of the most frequent problems.
• Staff Lack of Knowledge: Employees, especially in purchasing and warehouse, who do not understand the importance and requirements of REACH and RoHS.
• Mixing of Parts: Conforming and nonconforming parts stored together, leading to accidental use of restricted materials.
• Dependence on Unqualified Suppliers: Acquiring parts from suppliers who cannot prove compliance, often for cost reasons.
• Ignorance about SVHCs in Articles: Failure to recognize that even 'non-chemical' parts may contain above-limit SVHCs.
• Use of Lead Solder: In EEE repairs, the continued use of lead solder in environments that require RoHS compliance.
• Lack of Internal Audits: Lack of a systematic process to verify adherence to compliance policies.

8. Penalties and Legal Responsibilities

Non-compliance with REACH and RoHS has serious consequences, both internationally and nationally:

• Fines and Sanctions in the EU (for exporters): Brazilian companies that export to the EU and do not comply with the directives can face substantial fines, ranging from tens of thousands to hundreds of thousands of Euros per infraction, in addition to bans on entry into the European market and product recalls.
• Environmental Fines in Brazil: Although REACH and RoHS are not direct Brazilian laws, the use of dangerous substances in violation of safety and environmental principles can lead to sanctions under the Environmental Crimes Law (Law No. 9,605/98) and state and municipal regulations. Fines can range from R$5,000 to R$50,000 or more per infraction, depending on the severity and recurrence, applied by bodies such as IBAMA and environmental departments.
• Civil Liability: Damage to the health of workers or the environment resulting from the use of dangerous substances can generate public or private civil actions, with high compensation.
• Labor Responsibility: Failure to comply with NRs, especially NR-09 (PPRA), NR-15 (Unhealthy Activities and Operations) and NR-10/NR-12 (Safety in Electricity and Machines), may result in fines from the Ministry of Labor and Employment, interdiction of equipment and processes, and regressive actions from the INSS.
• Damage to Reputation and Business: The loss of credibility in the market, the difficulty in attracting international partners and the exclusion from global supply chains represent significant financial and strategic losses.
• Insurance Issues: Non-compliance may be interpreted as negligence, potentially invalidating insurance coverage for accidents or damages.

9. Conclusion

REACH and RoHS compliance is more than a regulatory requirement; It is a strategic imperative for Brazilian manufacturing. It ensures worker safety, environmental protection and competitiveness in the global market. MRO plays a central role in this process, being the entry point for many essential components. The careful selection of suppliers and the implementation of robust verification processes are essential.

UNITEC-D GmbH understands the complexity of these regulations and offers a portfolio of industrial spare parts that meet the highest compliance and quality standards. Our components are accompanied by the necessary documentation, ensuring transparency and security for your operations.

To ensure the compliance and security of your operations, consult the UNITEC-D E-catalog for certified components.

10. References

• Regulation (EC) No 1907/2006 of the European Parliament and of the Council, of December 18, 2006, relating to the registration, evaluation, authorization and restriction of chemical substances (REACH).
• Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain dangerous substances in electrical and electronic equipment (RoHS 2).
• ABNT NBR 14725-2:2023 - Chemicals — Information on safety, health and the environment — Part 2: Hazard classification system.
• ABNT NBR 14725-4:2023 - Chemical products — Information on safety, health and the environment — Part 4: Safety data sheet (SDS).
• Law No. 9,605, of February 12, 1998 - Provides for criminal and administrative sanctions arising from conduct and activities harmful to the environment.
• Law No. 12,305, of August 2, 2010 - Establishes the National Solid Waste Policy.
• Regulatory Standard NR-09 - Environmental Risk Prevention Program (PPRA). SEPRT Ordinance No. 6,735, of March 10, 2020.
• Regulatory Standard NR-10 - Safety in Electrical Installations and Services. SEPRT Ordinance No. 915, of July 30, 2019.
• Regulatory Standard NR-12 - Safety at Work in Machines and Equipment. SEPRT Ordinance No. 916, of July 30, 2019.
• Regulatory Standard NR-15 - Unhealthy Activities and Operations. SEPRT Ordinance No. 6,735, of March 10, 2020.
• INMETRO ordinances relevant to certification of electronic equipment and components.