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.
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.
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.
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.
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
- 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)
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.
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.
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.
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.
| REACH Element | Requirement |
|---|---|
| Registration Threshold | 1 metric ton per year |
| Compliance Check | 5% of registration dossiers |
| Consumer Inquiry Response Time | 45 days |
| Nanomaterial Regulation | Introduced in 2018 |
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.
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.
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.
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 |
|---|---|---|
| Manufacturers | Register substances, submit dossiers | >1 tonne/year |
| Importers | Register imported substances | >1 tonne/year |
| Only Representatives | Represent non-EU manufacturers | N/A |
| Downstream Users | Implement safety measures, communicate risks | N/A |
| Distributors | Relay chemical information | N/A |
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.
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.
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.
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.
| Category | Definition | Examples |
|---|---|---|
| Substances | Chemical elements and compounds | Metals, organic compounds |
| Mixtures | Combinations of two or more substances | Paint, cleaning products |
| Articles | Objects with specific shape, surface, or design | Furniture, electronics, packaging |
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.
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.
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).
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.
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.
By following these steps, businesses can meet REACH compliance and avoid big fines, up to $130,000 per issue. 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.
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.
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.
| Tonnage Band | Information Required |
|---|---|
| 1-10 tonnes/year | Basic physicochemical data |
| 10-100 tonnes/year | Additional toxicological and ecotoxicological information |
| 100-1000 tonnes/year | Comprehensive toxicity and environmental fate studies |
| 1000+ tonnes/year | Full dataset including long-term toxicity studies |
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.
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.
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.
The evaluation process includes:
- Reviewing dossier completeness and accuracy
- Assessing hazard and risk information
- Requesting additional data or testing when needed
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.
By June 2023, there were 235 SVHCs. 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.
Efficient compliance monitoring and risk mitigation strategies are essential for businesses to navigate REACH regulations successfully.
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.
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.
Substances of Very High Concern (SVHCs)
SVHCs are chemicals that are very dangerous to humans or the environment. By July 2021, 219 substances were marked as SVHCs and added to a list for special permission. These chemicals face strict rules and need special okay to be used.
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.
Businesses must know the chemicals in their products and follow REACH rules. They also need to give safe handling tips to customers.
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.
Good auditing and enforcing policies are key to following these rules.
| REACH Aspect | Key Figures |
|---|---|
| Pre-registered substances | 143,000 |
| Current SVHCs | 219 |
| Cases lacking safety info | 211 out of 286 |
| Substances evaluated | 94 out of 352 prioritized |
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.
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.
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.
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.
| Communication Requirement | Threshold | Purpose |
|---|---|---|
| Standard SDS | Hazardous substances | Basic safety information |
| Extended SDS with exposure scenarios | ≥10 tonnes/year | Detailed risk management |
| Authorization information | All quantities | Regulatory compliance |
| Registration numbers | When available | Traceability |
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.
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.
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.
Risk Reduction
Following REACH rules helps businesses avoid big legal and financial risks. Not following these rules can lead to fines of up to $130,000 per issue. Being compliant means you don’t face these big fines or legal trouble.
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.
| Benefit | Impact |
|---|---|
| Market Access | Entry to EU and EEA markets |
| Risk Reduction | Avoid fines up to $130,000 per violation |
| Enhanced Reputation | Improved trust and stakeholder relationships |
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, businesses set themselves up for success worldwide.
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.
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.
Here are some tips for doing well with compliance:
- Scrubbing Bills of Materials (BOMs)
- Collecting full-disclosure chemical substance information from suppliers
- Selecting appropriate software tools for compliance management
- Establishing comprehensive internal chemical substance databases
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.
| Compliance Aspect | Challenge | Best Practice |
|---|---|---|
| Data Collection | Verifying chemical composition of all components | Use specialized software tools |
| Resource Management | Limited in-house expertise | Consider outsourcing or training |
| Supplier Communication | Inconsistent data from suppliers | Establish clear communication protocols |
| Data Evaluation | CAS number mismatches, incomplete information | Implement rigorous data validation processes |
By using these strategies, companies can better handle REACH compliance. This ensures a strong framework and reduces risks from regulations.
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.
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.
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 puts businesses ahead in a changing world.
FAQ
What is REACH?
REACH is a European Union rule. It means Registration, Evaluation, Authorization, and Restriction of Chemicals. It helps protect people and the environment from chemicals in industry and products.
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.
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, might need testing, register with the European Chemicals Agency (ECHA), and keep in touch with your supply chain.
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. REACH has rules for using and limiting SVHCs because they’re dangerous.
What are the benefits of REACH compliance?
Being REACH compliant means you avoid fines and legal trouble, 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.
What are the challenges in REACH compliance?
REACH can be hard because it’s complex and keeps changing. There’s a 1 tonne/year rule for registering, and it affects global companies and non-chemical industries. Companies going through changes also find it tough.
What are best practices for REACH compliance?
To follow REACH well, stay updated on new rules, check your registration often, and quickly handle any changes in your chemicals. If you’re unsure, get help from experts.
