In today’s global market, following rules about chemicals is key for businesses. REACH compliance is a big deal for companies working with chemicals in the European Union. It started on June 1, 2007, to protect people and the environment from chemicals. Looking ahead, a major revision, the REACH Recast, is expected in late 2025, modernizing the legislation to simplify compliance, digitalize documentation, and strengthen hazard regulations.
REACH means Registration, Evaluation, Authorization, and Restriction of Chemicals. It affects many industries, not just chemical makers. Any business that imports, uses, or sells substances in the EU must know and follow these rules. The law has 141 articles, each with its own rules, and the upcoming Recast will introduce even more refined requirements.
If your company uses more than 1 tonne of a substance a year, you must register with the European Chemicals Agency (ECHA). You’ll need to provide detailed information and share your registration number with customers. The more you use a substance, the more safety checks you’ll need. Under the new rules, these registrations will have a 10-year validity period, after which renewal and completeness checks will be required, potentially leading to revocation for expired or incomplete dossiers.
Understanding your role in the supply chain is key to following REACH. Whether you make, import, use, or distribute substances, you have certain duties. For example, Article 32 of REACH says you must share safety info with others in the supply chain. This keeps products safe from start to finish. The forthcoming Digital Product Passports will further enhance the sharing of chemical compliance information throughout supply chains.
Key Takeaways
- REACH affects most EU companies, not just chemical makers
- You must register substances if you use or make over 1 tonne a year, with new requirements for polymers and low-tonnage substances under the Recast
- Each role in the supply chain has its own set of rules
- You’ll need safety reports for substances over 10 tonnes a year
- Non-EU companies must have EU reps for compliance
- Identifying and managing risks is a main part of REACH
- Special rules apply to Substances of Very High Concern (SVHCs), with an enhanced obligation to update dossiers immediately upon identification
- The upcoming REACH Recast will introduce significant changes, including 10-year registration validity and digital product passports
Understanding REACH Regulation
REACH is a key rule in the European Union that makes sure chemicals are safe. It affects businesses in the EU and other places too. It sets rules for safety and protecting the environment. The upcoming REACH Recast, part of the EU Chemicals Strategy for Sustainability under the European Green Deal, aims to make chemicals legislation even more transparent, efficient, and protective.
What is REACH?
REACH means Registration, Evaluation, Authorisation and Restriction of Chemicals. It started on June 1, 2007. It covers EU countries, Iceland, Liechtenstein, and Norway. Companies must register chemicals they bring into the EU if they use more than 1 metric ton a year. This rule applies to both the companies making and bringing in these chemicals. The revised REACH legislation will also extend registration to include some polymers and low-tonnage substances, previously exempt.
Objectives of REACH
REACH’s main goals are to protect people and the environment and help the EU chemical industry. Companies must show they know and manage the risks of the chemicals they make and sell in the EU. The ECHA checks some registrations to make sure they meet the rules. The upcoming changes aim to further accelerate risk management for high-hazard substances and enhance data quality.
Scope and Application
Most EU companies have to follow REACH. It covers chemicals used in many areas, from industry to everyday products. Companies must answer questions from consumers about harmful substances in 45 days. The rule also looks at nanomaterials, with new rules since 2018. Safety Data Sheets were updated in 2020 to help with registration. Significantly, the REACH Recast will introduce new hazard classes for substances, including endocrine disruptors and persistent, mobile, and toxic (PMT) substances, expanding the scope of its safety considerations.
| REACH Element | Requirement | Upcoming Changes (REACH Recast) |
|---|---|---|
| Registration Threshold | 1 metric ton per year | To include some polymers and low-tonnage substances |
| Compliance Check | 5% of registration dossiers | Increased scrutiny and regular dossier completeness checks |
| Registration Validity | Indefinite (currently) | 10-year validity period, requires renewal |
| Consumer Inquiry Response Time | 45 days | Remains, potentially supported by Digital Product Passports |
| Nanomaterial Regulation | Introduced in 2018 | Further integration into risk assessment |
Key Roles Under REACH
REACH affects many companies across different sectors. It sets clear roles and responsibilities. Knowing these roles is key for good auditing and enforcing policies under REACH. The upcoming REACH Recast will strengthen EU-wide enforcement and harmonize penalties, making clear understanding of these roles even more critical.
Manufacturers are at the core of REACH compliance. They must register substances made or brought in over 1 tonne a year. This means they have to give the European Chemicals Agency detailed info about the substance and how it’s used. Under the new regulations, they will also face mandatory dossier updates whenever new hazard data emerges or a substance is identified as an SVHC.
Importers have similar duties to manufacturers. For companies outside the EU sending goods to the EU, they can choose an Only Representative (OR). This EU-based person or company takes care of the registration for EU importers, making compliance easier.
Downstream users play a big part in using chemicals safely. They put safety steps in place at their sites and share risk info with the European Chemicals Agency when needed. This helps keep the supply chain safe. The introduction of Digital Product Passports will provide a more streamlined way for them to access and share critical chemical information.
Distributors help move chemical substances safely through the supply chain. They share information about the chemicals to help everyone use them safely. Their role is crucial for keeping things transparent and safe.
| Role | Key Responsibilities | Registration Threshold | Impact of REACH Recast |
|---|---|---|---|
| Manufacturers | Register substances, submit dossiers | >1 tonne/year | Mandatory dossier updates, 10-year validity for registrations |
| Importers | Register imported substances | >1 tonne/year | Mandatory dossier updates, 10-year validity for registrations |
| Only Representatives | Represent non-EU manufacturers | N/A | Increased oversight to ensure adherence to new validity periods and updates |
| Downstream Users | Implement safety measures, communicate risks | N/A | Digital Product Passports for improved information access |
| Distributors | Relay chemical information | N/A | Enhanced responsibility in a digitalized information flow |
Companies often play many roles under REACH. This means they need thorough auditing and strict policy enforcement to be fully compliant with all their activities, especially with the upcoming stricter enforcement mechanisms.
Substances, Mixtures, and Articles: Defining Your Product
It’s key for businesses to know about REACH product categories. They help meet legal needs and follow ethical rules. Products are split into substances, mixtures, and articles, each with its own rules for data and compliance. The upcoming REACH Recast will broaden the scope for registration to include certain polymers and low-tonnage substances, requiring even more precise classification.
Substances
Substances are chemicals, either natural or made by humans. They can be solids, liquids, gases, gels, or pastes. UVCB substances are complex, often organic, with many parts or mixtures that seem like one thing. Under the revised REACH, new hazard classes for substances, such as endocrine disruptors and persistent, mobile, and toxic (PMT) substances, will also be recognized, leading to faster restrictions.
Mixtures
Mixtures are made of two or more substances blended together. They can be created by mixing or reacting substances. Knowing if something is a substance or a mixture helps with how it’s classified and registered under REACH.
Articles
Articles are made with a special shape, surface, or design for a certain use. Things like plastics, metals, or fabrics become articles after being processed. Packaging is also seen as an article under REACH. The introduction of Digital Product Passports will play a significant role in tracing chemical content within articles throughout their lifecycle.
| Category | Definition | Examples | Impact of REACH Recast |
|---|---|---|---|
| Substances | Chemical elements and compounds | Metals, organic compounds | New hazard classes (e.g., endocrine disruptors, PMTs) and broader registration scope |
| Mixtures | Combinations of two or more substances | Paint, cleaning products | Increased need for accurate data on components due to extended substance scope |
| Articles | Objects with specific shape, surface, or design | Furniture, electronics, packaging | Digital Product Passports to track chemical information throughout supply chain |
Getting the right category for your product is key. It helps with REACH rules, keeps data safe, and follows ethical standards. Companies need to check their products closely to meet REACH and keep customers safe, especially as the regulations evolve.
REACH Compliance: Steps for Businesses
For businesses in the European Union, achieving REACH compliance is key. It involves several important steps. First, companies must figure out their role in the supply chain and what products they handle, recognizing that the scope will expand under the forthcoming REACH Recast.
Then, businesses should learn about REACH laws and guidance. This helps them understand their specific duties. For example, if a company makes or imports over 1 tonne of a substance each year, they must register with the European Chemicals Agency (ECHA). The upcoming Recast will additionally require registration for certain polymers and low-tonnage substances, expanding the number of entities that need to comply.
Keeping up with compliance is the next step. This means checking supply chains and products for banned chemicals. Companies need to get info from suppliers and might need to test to confirm the presence and amount of restricted substances. Remember, substances on the Substances of Very High Concern (SVHC) list can’t be more than 0.1% of the product’s weight in the EU, and companies have an enhanced obligation to update dossiers immediately when SVHC status or new hazard data emerges.
Good communication in the supply chain is vital for REACH compliance. Companies must share safe use info to buyers if their products have substances from the ECHA Candidate List over 0.1% by weight. It’s important to keep an eye on REACH compliance rules as they can change, particularly with the introduction of Digital Product Passports that will enhance the traceability and communication of chemical information.
By following these steps, businesses can meet REACH compliance and avoid big fines. Non-compliance can lead to significant penalties, which will be further harmonized and strengthened across the EU under the upcoming Recast. Being compliant not only opens doors to EU markets but also boosts a company’s reputation for following the rules.
Registration Process and Requirements
REACH compliance is key for businesses in the European Economic Area (EEA). The registration process is a big part of the REACH framework. It makes sure chemicals are used safely across industries. The upcoming REACH Recast will introduce a 10-year validity period for registrations, emphasizing the need for robust and up-to-date dossier submissions.
Tonnage Thresholds
Companies must register substances with the European Chemicals Agency (ECHA) if they make or bring in one tonne or more each year. This rule covers substances alone, in mixtures, and sometimes in articles. A significant change under the revised REACH will expand eligibility for registration to include some polymers and low-tonnage substances that were previously exempt, broadening the scope of obligated entities.
Information Requirements
What you need to register depends on how much you use. You must give details about the substance, its uses, and safety checks. If you use more than 10 tonnes a year, you also need a Chemical Safety Report. Critically, companies will have a mandatory obligation to update dossiers immediately when new hazard data emerges, changes in classification occur, or a substance is identified as an SVHC, ensuring that registrations remain current and protective.
| Tonnage Band | Information Required | Duration of Validity | Key Updates from REACH Recast |
|---|---|---|---|
| 1-10 tonnes/year | Basic physicochemical data | 10 years | New hazard classes (e.g., endocrine disruptors) to be considered |
| 10-100 tonnes/year | Additional toxicological and ecotoxicological information | 10 years | Mandatory dossier updates when new hazard data emerges |
| 100-1000 tonnes/year | Comprehensive toxicity and environmental fate studies | 10 years | Renewals required after expiration |
| 1000+ tonnes/year | Full dataset including long-term toxicity studies | 10 years | ECHA may revoke expired or incomplete registrations |
Chemical Safety Reports
These reports are crucial for substances made or brought in in amounts of 10 tonnes or more each year. They outline safe use conditions and risk management steps. This is a key part of following REACH rules. The upcoming changes will place additional emphasis on the adequacy and timeliness of these reports, particularly in light of new hazard classifications and continuous dossier update requirements.
Following these rules helps businesses stay in line with REACH. It ensures they can sell products and lowers risks from chemical use in the EEA, with greater scrutiny and a more dynamic compliance environment under the revised framework.
Evaluation of Substances Under REACH
REACH evaluation is key for managing risks and ensuring rules are followed. The European Chemicals Agency (ECHA) checks each registration for its correctness. EU Member States also look into certain substances to protect health and the environment. Under the forthcoming REACH Recast, there will be increased emphasis on continuous evaluation and timely dossier updates to enhance data quality and risk management.
The evaluation process includes:
- Reviewing dossier completeness and accuracy
- Assessing hazard and risk information, now including new hazard classes like endocrine disruptors and PMT substances
- Requesting additional data or testing when needed, with mandatory dossier updates for registrants when new hazard data emerges
Companies must register chemicals over one metric ton yearly, per substance, based on who makes it. Not following the rules can lead to products being banned in the EU. REACH checks for substances on Annex XVII and the Candidate List of SVHCs. The upcoming changes will also implement stricter EU-wide enforcement and harmonized penalties to ensure consistent application.
By December 2023, there were 247 SVHCs on the Candidate List, an increase from previous counts. If a substance is over 0.1% of the product’s weight, it needs special permission. Companies must keep track of dangerous chemicals in their products. They must tell customers and ECHA about substances above a certain level, and immediately update their dossiers when a substance is identified as an SVHC or new hazard information becomes available.
Efficient compliance monitoring and risk mitigation strategies are essential for businesses to navigate REACH regulations successfully, especially with the enhanced focus on data quality, continuous updates, and stricter enforcement under the upcoming Recast.
Many companies use third-party testing services to stay compliant. These services provide SVHC testing, detailed reports, and expert advice for different products. This helps businesses keep their products safe and meet REACH standards, preparing them for the more dynamic compliance demands ahead.
Authorization and Restriction of Chemicals
REACH regulation is key in managing chemicals in the European Union. It affects up to 143,000 substances worldwide. This section looks at how it authorizes and restricts chemicals, which is vital for safety and policy, especially with the significant updates coming from the REACH Recast.
Substances of Very High Concern (SVHCs)
SVHCs are chemicals that are very dangerous to humans or the environment. By December 2023, there were 247 substances on the Candidate List for authorization, significantly more than earlier counts. These chemicals face strict rules and need special approval to be used. Companies have an enhanced obligation to immediately update their dossiers when a substance is identified as an SVHC or new hazard data emerges.
Authorization Process
The authorization process makes sure high-risk chemicals are used safely. Companies must get approval to use SVHCs listed in Annex 14 of REACH. This includes a 90-day public comment period and a detailed check of risks and benefits. The upcoming REACH Recast aims to accelerate risk management for high-hazard substances, potentially streamlining or strengthening aspects of this process.
Businesses must know the chemicals in their products and follow REACH rules. They also need to give safe handling tips to customers. The introduction of Digital Product Passports will further facilitate the communication of authorization-related information throughout the supply chain.
Restriction Measures
REACH also limits or bans certain chemicals in the EU. These rules are in Annex 17 of REACH. Before making these rules, there’s a public comment period. Companies might need to change their products to meet REACH standards. The new REACH will introduce a faster restriction process for substances with certain hazard classifications (e.g., endocrine disruptors, PMTs), based on hazard alone, without extensive risk assessment in some cases.
Good auditing and enforcing policies are key to following these rules, particularly as enforcement becomes stronger and harmonized across the EU.
| REACH Aspect | Key Figures | Impact/Updates from REACH Recast |
|---|---|---|
| Pre-registered substances | 143,000 | Continued importance, but with 10-year validity and dossier updates |
| Current SVHCs on Candidate List | 247 (as of Dec 2023) | Enhanced obligation for immediate dossier updates upon identification |
| Cases lacking safety info | 211 out of 286 (original ECHA findings) | Increased scrutiny and ECHA may revoke incomplete registrations |
| Substances evaluated | 94 out of 352 prioritized (original ECHA findings) | More systematic and continuous evaluation, faster restriction for high-hazard substances |
These numbers show how important strict auditing and policy enforcement are in following REACH. Companies need to keep up with the SVHC list and change their ways to stay safe and compliant, especially in anticipation of the legally binding changes expected by late 2025 or early 2026.
Supply Chain Communication and Obligations
Good communication is key for following REACH rules. Companies must give Safety Data Sheets (SDS) to users, with important info on the substance, how to handle it, and safety tips. This keeps data safe and follows ethical rules in the supply chain. The upcoming REACH Recast, with its vision for Digital Product Passports, will significantly modernize and streamline this communication.
Suppliers must give SDS for substances that are hazardous, last a long time, or build up in the body. They also need SDS for substances that might need special permission. For substances made in large amounts, SDS must include more details on how they might be used. Under the revised framework, the flow of chemical data will be more digitized and integrated, requiring companies to adapt their information exchange systems.
Talking about information is more than just SDS. Suppliers must share info on substances needing special permission, any limits, risk management steps, and registration numbers if they have them. Being open helps follow ethical standards and makes sure everyone knows the risks. The Digital Product Passports will aim to enhance this transparency by providing comprehensive chemical compliance information for products throughout their lifecycle.
| Communication Requirement | Threshold | Purpose | Impact of REACH Recast / Digitalization |
|---|---|---|---|
| Standard SDS | Hazardous substances | Basic safety information | Complementary digital data exchange via product passports |
| Extended SDS with exposure scenarios | ≥10 tonnes/year | Detailed risk management | Integrated into digital information flow, possibly simplified access |
| Authorization information | All quantities | Regulatory compliance | Easier traceability through Digital Product Passports |
| Registration numbers | When available | Traceability | Automated links and verification in digital systems |
| SVHC status updates | Immediate upon identification | Risk management, regulatory compliance | Mandatory, faster dossier updates required |
Companies should talk well with suppliers and customers to share info, like changes in what’s in the substance or how it’s classified. Being proactive helps keep data safe and ethical, and makes following REACH rules easier for everyone in the supply chain, especially with the anticipated implementation of legally binding changes and digital tools.
Benefits of REACH Compliance for Businesses
REACH compliance brings big benefits to businesses. Companies that follow these rules can enter new markets and lower risks. Let’s look at the main advantages of sticking to these regulations, which will become even more pronounced with the upcoming modernized REACH framework.
Market Access
Being REACH compliant means you can sell in the European Union and other places. This includes EU Member States, Iceland, Lichtenstein, and Norway. This can lead to more sales and growth chances. The consistent application and strengthened enforcement under the REACH Recast will provide even clearer pathways to these markets for compliant businesses.
Risk Reduction
Following REACH rules helps businesses avoid big legal and financial risks. Not following these rules can lead to significant fines. Being compliant means you don’t face these big fines or legal trouble, which will be further minimized by stronger, harmonized penalties across the EU under the revised legislation. Furthermore, continuous dossier updates and more robust evaluation processes will lead to better risk management for both companies and consumers.
Enhanced Reputation
Being REACH compliant shows a company cares about safety and being green. This builds trust with customers and others. It shows a business is ethical and cares about people and the planet. Adhering to the more transparent and protective standards of the upcoming REACH Recast will only further amplify this positive reputation, demonstrating commitment to the highest environmental and health standards.
| Benefit | Impact | Enhancement from REACH Recast |
|---|---|---|
| Market Access | Entry to EU and EEA markets | Clearer compliance pathways due to harmonized enforcement |
| Risk Reduction | Avoid fines and legal issues | Stronger, harmonized penalties and better data quality reduce compliance risks |
| Enhanced Reputation | Improved trust and stakeholder relationships | Demonstrates commitment to updated, higher environmental and health standards |
REACH compliance is more than just following rules. It’s a smart move that can improve your market position, lower risks, and boost your reputation. By focusing on REACH compliance, and proactively preparing for the anticipated changes, businesses set themselves up for success worldwide and align with the EU’s broader sustainability goals.
Challenges and Best Practices in REACH Compliance
REACH compliance is tough for businesses, especially in the electronics industry. It’s complex and keeps changing. Companies need a strong plan and framework to follow. The forthcoming REACH Recast will introduce additional layers of complexity, such as 10-year registration validity, extended scope for polymers, and new hazard classes, requiring proactive adaptation.
Electronic OEMs struggle with collecting data. They must check the chemicals in every part. This is hard, especially when they don’t have a team for REACH compliance. The mandatory dossier updates whenever new hazard data emerges or SVHC status changes will demand continuous data management.
Here are some tips for doing well with compliance:
- Scrubbing Bills of Materials (BOMs)
- Collecting full-disclosure chemical substance information from suppliers, leveraging upcoming Digital Product Passports for streamlined data exchange
- Selecting appropriate software tools for compliance management that can handle dynamic updates and new regulatory requirements
- Establishing comprehensive internal chemical substance databases capable of continuous updates and cross-referencing with evolving SVHC lists and hazard classifications
- Proactively preparing for the 10-year registration validity period and associated renewal requirements
Outsourcing data collection can help ease the load on your team. It might make things more efficient. Having the right software is key for managing REACH compliance. It helps with collecting data, setting up databases, and analyzing substances, preparing for the digital and stricter enforcement aspects of the revised REACH.
| Compliance Aspect | Challenge | Best Practice | Emerging Solution/Update from Recast |
|---|---|---|---|
| Data Collection | Verifying chemical composition of all components | Use specialized software tools | Digital Product Passports for enhanced data exchange |
| Resource Management | Limited in-house expertise | Consider outsourcing or training | Greater need for specialized knowledge of new hazard classes and dynamic updates |
| Supplier Communication | Inconsistent data from suppliers | Establish clear communication protocols | Digital Product Passports mandate clearer and standardized information flow |
| Data Evaluation | CAS number mismatches, incomplete information | Implement rigorous data validation processes | Mandatory dossier updates, ECHA may revoke expired/incomplete registrations |
| Registration Validity | Maintaining current registrations | Regular review and update schedule | 10-year validity, requires renewal, ECHA scrutiny |
By using these strategies, companies can better handle REACH compliance. This ensures a strong framework and reduces risks from regulations, allowing them to thrive in a more transparent and strictly controlled chemical market.
Conclusion
REACH compliance is key for businesses in or selling to the EU. It helps protect people and the environment by managing risks and checking for compliance. With 21 PFAS substances being checked and 10 marked as Very High Concern, the focus is on safety. The Candidate List of Substances of Very High Concern has grown to 247 SVHCs as of December 2023, underscoring the dynamic nature of these regulations and the enhanced obligation for companies to immediately update dossiers upon new hazard identification.
Companies face many steps, like registering and evaluating substances. The EU has a plan to manage PFAS through rules. With 51 proposals for new rules on PFAS, staying updated is crucial to avoid issues. Furthermore, the extensive REACH Recast, expected in late 2025, will introduce significant changes, including a 10-year validity period for registrations, expansion to some polymers and low-tonnage substances, new hazard classes like endocrine disruptors, and the implementation of Digital Product Passports.
Even though following REACH can be tough, the rewards are big. It opens up markets, lowers risks, and boosts a company’s image. As the EU plans to cut industry emissions by 70% by 2030, being REACH compliant, and proactively preparing for the upcoming changes, puts businesses ahead in a changing world and aligns them with the EU Chemicals Strategy for Sustainability.
FAQ
What is REACH?
REACH is a European Union rule, meaning Registration, Evaluation, Authorization, and Restriction of Chemicals. It helps protect people and the environment from chemicals in industry and products. A significant revision, the REACH Recast, is expected in late 2025 to modernize the legislation.
Who needs to comply with REACH?
Companies that make, import, use, or sell chemicals in the European Economic Area (EEA) and Great Britain (GB) must follow REACH. This includes makers, importers, users, and sellers of chemicals. The upcoming REACH Recast will extend registration obligations to certain polymers and low-tonnage substances.
What are the key steps for REACH compliance?
To follow REACH, you need to know your role and duties. Check your supply chains and products for banned chemicals. Get info from suppliers (potentially via Digital Product Passports), test as needed, register with the European Chemicals Agency (ECHA) with a 10-year validity period, and maintain continuous communication with your supply chain. Be prepared for mandatory dossier updates whenever new hazard data or SVHC status emerges.
What are Substances of Very High Concern (SVHCs)?
SVHCs are chemicals that could cause cancer, harm genes, be toxic to reproduction, or build up in the body. As of December 2023, there are 247 SVHCs on the Candidate List. REACH has rules for using and limiting SVHCs because they’re dangerous, with enhanced obligations for immediate dossier updates and communication.
What are the benefits of REACH compliance?
Being REACH compliant means you avoid fines and legal trouble (which will be more harmonized and stronger under the Recast), lower risks, and protect yourself. It also shows you care about the planet and ethics. Plus, it opens up markets in the EU, Iceland, Lichtenstein, and Norway, providing a competitive advantage.
What are the challenges in REACH compliance?
REACH can be hard because it’s complex and keeps changing. Challenges include the 1 tonne/year registration rule (now extending to some polymers and low-tonnage substances), continuous dossier updates, managing new hazard classes, and navigating the global supply chain. Companies need to prepare for the comprehensive changes introduced by the REACH Recast, expected in late 2025.
What are best practices for REACH compliance?
To follow REACH well, stay updated on new rules, proactively prepare for the REACH Recast (including 10-year registration validity and expanded scope), regularly check and update your registrations, and quickly handle any changes in your chemicals or their classification. Utilize tools like Digital Product Passports for improved data flow. If you’re unsure, get help from experts.
