The European Union’s REACH regulation is a key law aimed at keeping people and the environment safe from chemicals. REACH makes companies prove the safety of the chemicals they use in the EU. It encourages safer ways to test chemicals, reducing animal tests and helping the EU chemicals industry grow.
Companies must register chemicals over 1 tonne a year with the European Chemicals Agency (ECHA)1. If they make or import more than 10 metric tonnes a year, they need to submit a detailed Chemical Safety Report (CSR)1. The rule also has a special process for very dangerous substances, like those that can cause cancer or mess with hormones1.
REACH affects many businesses, not just those in the chemical industry1. It covers sectors like fashion, leather goods, toys, and more1. It says an ‘article’ is something made or designed, where what’s in it doesn’t matter much. This matters a lot for things like clothes, shoes, toys, and baby items1. To follow REACH, companies must handle risks, follow rules on banned substances, and look for safer options1.
Key Takeaways
- REACH is a comprehensive EU regulation aimed at improving the protection of human health and the environment from chemical risks.
- Companies must register substances exceeding 1 tonne per year with the European Chemicals Agency (ECHA).
- REACH defines an ‘article’ as an object where chemical composition is less relevant, impacting various industries.
- Compliance with REACH involves managing substance risks, adhering to legal limits, and exploring alternative safer materials.
- REACH promotes the use of alternative methods for hazard assessment to reduce animal testing.
What is REACH?
REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. It’s a rule to protect people and the planet from harmful chemicals2. It started in the European Union in June 2007. Now, companies must handle the risks of the chemicals they make and sell3.
Registration, Evaluation, Authorization, and Restriction of Chemicals
REACH has four main parts:
- Registration: Companies must tell the European Chemicals Agency (ECHA) about the chemicals they make or bring into the EU3.
- Evaluation: ECHA and EU countries check the info from companies to see if the chemicals are safe3.
- Authorization: Some chemicals need special permission because they’re very dangerous. Companies must prove they’re safe or that they’re really useful2.
- Restriction: If a chemical is too risky, the EU can limit how it’s made, used, or sold3.
Improving Human Health and Environmental Protection
REACH’s main aim is to keep people and the environment safe from chemicals3. It makes companies look at the risks of their chemicals. This helps use safer chemicals and less animal testing2.
“REACH ensures a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation.” – European Chemicals Agency (ECHA)
REACH Compliance: A Company’s Responsibility
The REACH regulation makes companies prove the safety of chemicals they make or sell in the European Union4. They must know and handle the risks of the substances they work with. They need to show the European Chemicals Agency (ECHA) how these substances can be used safely4. If they don’t, the authorities might limit the use of dangerous substances4.
Identifying and Managing Risks of Substances
Under REACH, companies must collect and check the info on the chemicals they use5. They need to know the health and environmental risks and take steps to manage them4. Working together with other companies is often needed when registering substances with ECHA4.
Communicating Risk Management Measures
Good risk communication is key to following REACH4. Companies must give users the right info on safely handling and using the substances they offer. This includes safety data sheets and exposure scenarios5. This way, risks are managed well in the supply chain, keeping people and the environment safe4.
“Compliance with REACH is not just a regulatory requirement, but a moral and ethical duty to ensure the responsible use of chemicals.”
REACH compliance is a duty for everyone in the chemical supply chain, from makers and importers to users4. By identifying, managing, and sharing risks, companies help make sure chemicals are used safely and sustainably in the European Union4.
How REACH Works
The REACH regulation sets up detailed steps for handling chemical substances. Companies making or bringing in over 1 tonne of substances yearly must register them with the European Chemicals Agency (ECHA)6. ECHA checks these registrations to make sure they meet REACH standards.
Procedures for Collecting and Assessing Chemical Information
Companies need to collect and send in info on their substances’ properties, uses, and risks6. This info helps authorities and ECHA’s experts see if substances can be safely used6. If substances are too risky, they might be limited or allowed only under certain conditions.
Registration, Evaluation, and Authorization Processes
REACH has clear steps for registering, evaluating, and okaying chemicals in Europe6. Companies must do things like share substance details, submit paperwork, pay fees, and share info with others in the supply chain6. Following REACH can be tough, especially for those with complex supply chains. They need good supply chain management, openness, and sharing of data7.
REACH registration can cost from $100 USD and up, based on the materials and tests needed8. A simple test for a single-colored material might be about $320 USD, but a complex item like a wristwatch could be up to $740 USD8. Testing time for REACH can be from 7 to 21 days, depending on the lab and the product8.
“Effective supply chain management and transparency are crucial for maintaining REACH compliance. Companies must work closely with their suppliers to identify and manage the use of hazardous substances in their products.”
REACH’s Impact on Businesses
The REACH regulation affects companies across many sectors, even if they don’t work with chemicals9. Companies that make chemicals for their own use or to sell to others have big responsibilities under REACH. Importers bringing products into the EU/EEA from outside must also meet certain requirements. Downstream users who use chemicals in their work need to check they’re following REACH rules.
Manufacturers, Importers, and Downstream Users
REACH’s effects on businesses depend on the company’s size and how it handles chemicals9. Larger companies usually need to spend more time and resources to follow REACH. The rule covers about 30,000 chemicals that need safety data to be sold in Europe9. Around one-third of chemicals made or imported in large amounts must have a detailed Chemical Safety Report (CSR).
REACH brings both challenges and chances for chemical companies9. The SIEF process, which requires companies to work together on the same substances, worries the industry9. But, the rule also shows the value of the European market, a €10 billion (US$14 billion) economy with over 490 million consumers, making it key for chemical makers and suppliers9.
REACH has strict rules for substances that are very harmful, like carcinogens and toxic substances10. These substances need approval from the European Chemicals Agency (ECHA) before they can be sold10. Companies breaking REACH rules can face big fines, up to tens of thousands of euros, and could lose money from product recalls10.
As REACH changes, companies must keep an eye on updates from the ECHA10. New hazardous chemicals on the Candidate and Authorisation Lists mean companies must change their products and supply chains to stay in line with the law11. The wide impact of REACH shows it’s crucial for all companies to have a strong system for handling chemical issues.
The REACH Review Process
The European Commission must regularly update on REACH’s progress towards its goals12. The second review, in 2018, looked at how well REACH works, its efficiency, and its value to the EU13. It used info from EU countries, the European Chemicals Agency (ECHA), and stakeholder talks.
Evaluating REACH’s Effectiveness and Efficiency
The review checked if REACH meets its goals, like protecting health and the environment12. It looked at the data from REACH and what people think about its costs and benefits.
Stakeholder Consultation and Evidence Gathering
Many groups, like chemical makers and environmental groups, shared their views13. This made sure the review heard from a wide range of people. It aimed to understand how REACH affects everyone involved.
The review’s findings will shape future policy, making sure REACH keeps protecting health and the environment14.
The Second REACH Review (REACH REFIT Evaluation)
In 2018, the REACH REFIT evaluation looked deeply into the REACH regulation. It checked if it worked well, was efficient, and made sense. The review used many studies, reports, and talked to stakeholders, including ECHA’s review15.
Findings and Recommendations
The review found some important things and suggested ways to make the regulation better15. It said the regulation helped move chemical knowledge to Europe through ECHA. But, it pointed out areas that need more work15.
- The review said it’s hard to see if the REACH regulation met its goals15.
- It found that making things safe under REACH costs a lot more in Europe than in the USA. This hurts small and medium-sized businesses a lot15.
- The report said the strict rules and costs of REACH hit SMEs the hardest15.
- It also said the focus was mostly on the supply chain and worker safety. There wasn’t much thought about how it affects consumers15.
- The review showed that how well REACH is applied varies a lot between countries15.
After looking into these issues, the review made suggestions to fix the problems. It wanted to make sure safety and business competitiveness go hand in hand, especially for SMEs. It also wanted to make sure the rules work the same everywhere in the EU15.
“The REACH REFIT evaluation provided valuable insights and recommendations to strengthen the implementation of the REACH regulation, ensuring a balanced approach to chemical safety and industry competitiveness.”
https://www.youtube.com/watch?v=JO7H-ajADoQ
Challenges and Controversies Surrounding REACH
The European chemical industry has faced big REACH challenges lately. The European Commission is slow to update the REACH rule on chemical safety. This delay has sparked worries among environmental groups and others. They think the decision is influenced by the chemical industry’s struggles and a wish to please conservative politicians in Germany16.
The industry points out the effect of high energy costs. Some lawmakers say fighting climate change and making clean energy affordable should be the main goal16. This has led to a heated debate over the REACH controversies. Different groups push for their own priorities.
Even with these REACH challenges, the EU sticks to the REACH system. It started in 2007 and focuses on chemical safety17. The goal is to protect people and the environment by knowing more about chemicals used in the EU17.
But, the EU’s way of separating waste, products, and chemicals causes confusion. It’s hard to know if materials in the recycling loop are safe because we don’t know enough about them17. We need quick action to fix this and make a safe circular economy17.
| Obstacle | Explanation |
|---|---|
| Waste may contain substances no longer allowed in new products | This creates uncertainties regarding the safety of secondary material cycles due to a lack of information on substances of concern17. |
| Sectoral separation between waste, products, and chemicals regulation | This has resulted in a lack of information on substances of concern, hindering the transition to a circular economy17. |
As the EU deals with REACH challenges and REACH controversies, finding a balance is key. We need to keep chemical safety in check and help industries do well16. Working together, finding new testing ways, and a strong rule will help solve these big issues.
“The delay in revising the REACH regulation is concerning, as it raises questions about the EU’s commitment to protecting human health and the environment from hazardous chemicals.”
– Environmental Activist
The Future of REACH
The future of REACH in the European Union is uncertain. The European Commission is slow to revise the regulation18. Some lawmakers see this as a chance to focus on climate change and help the chemicals industry18. But others worry about the lack of progress in making chemicals safer for people and the environment18.
Ensuring chemical safety and supporting the EU’s chemicals industry will be tough18. The REACH regulation aims to reduce harmful chemicals. But businesses want stability to keep their place in the market18.
Navigating the REACH Revision
Reports suggest the REACH Revision could be adopted by Q4 202319. It might start taking effect between 2025 – 202719. The update will ask for more info on certain polymers and substances like endocrine disruptors19.
Companies need to get ready for new tests on chemicals18. The ECHA is updating its guides to help with these changes18. More details will be on their website18.
Non-EU companies can work with Only Representatives in the EU/EEA19. But the full effect of the REACH Revision depends on the final version and how it’s put into action19.
Companies should think about how the REACH Revision will affect their products19. This is especially true for products with substances like PFAS19.
“The main goal of the 2022 REACH revision is to ensure transparency and improve the predictability of ECHA’s evaluation practices.”
As REACH changes, businesses must keep up and adjust to stay competitive18. The path ahead is tough, but with good planning and working together, REACH can meet both industry and environmental needs18.
REACH and the EU’s Green Deal
The REACH regulation is key to the European Union’s Green Deal. This deal aims to make the continent “climate-neutral” by 205020. REACH supports the Green Deal’s goals of being sustainable and reducing carbon emissions21.
Chemicals are vital in renewable energy tech, like lubricants for wind turbines and solar panels21. Yet, balancing chemical safety with environmental goals has made revising REACH complex for the European Commission20.
The Role of Chemicals in Sustainability and Decarbonization
The EU wants to cut greenhouse gas emissions by 55% by 203021. This goal highlights the importance of chemicals in a sustainable economy. The chemical industry helps with clean energy, energy-saving buildings, and the circular economy21.
Plans to update REACH, set for 2020, are now delayed and uncertain20. Some lawmakers think the REACH review is off the table, but the Commission won’t confirm this20.
Environmental groups worry about the lack of action on REACH. They fear it will lead to more chemical pollution and support harmful industries20. Chemical companies, like BASF, are also concerned. They’re cutting back in Europe due to high energy costs and green regulations20.
The EU is struggling with balancing chemical safety, sustainability, and business needs. The future of REACH and its role in the Green Deal is still up in the air202122.
Best Practices for REACH Compliance
Ensuring REACH compliance is crucial for EU companies23. The REACH Regulation (EC 1907/2006) aims to improve health and the environment by reducing hazardous chemicals23. Not following REACH can lead to fines up to $130,000 per violation23.
To stay compliant, businesses must be proactive. They need to identify and manage risks from chemicals they use or import. They also need to share risk management with downstream users23. Companies outside the EU must ensure compliance through importers or a representative23.
Working with industry groups and keeping up with new rules helps companies meet REACH standards23. This keeps them competitive in the EU market23. Being REACH compliant opens doors to EU markets, including Iceland, Liechtenstein, and Norway23.
Key best practices for REACH compliance include:
- Registering with the European Chemicals Agency (ECHA) for substances over 1 tonne per year23.
- Sharing registration numbers with customers after registration23.
- Watching the 1 tonne per year limit closely, as many companies go over it23.
- Joining the ECHA’s evaluation process to review hazard and risk info23.
- Using Safety Data Sheets (SDS) for clear communication in the supply chain23.
- Working with experts for updates and deadlines on REACH23.
The REACH regulation has over 140 articles on compliance for various operations and products23. Navigating this can be tough, but best practices help companies stay compliant and access the EU market23.
Companies should also know about REACH’s growing scope24. It covers thousands of chemicals in electrical equipment, and the SVHC list keeps getting longer24.
Managing chemicals well is key for REACH compliance, but many electronics OEMs struggle with it24. Creating a database for chemicals and keeping a clean Bill of Materials (BOM) helps with compliance24.
To tackle these issues, companies are using software and third-party services for data and substance tracking under REACH24. A thorough approach to REACH compliance helps companies meet rules, protect health, and the environment23.
| Key REACH Compliance Requirements | Details |
|---|---|
| Registration | Registering with the European Chemicals Agency (ECHA) for substances over 1 tonne per year25. |
| Restricted Materials | Examples of restricted materials include CMR substances (carcinogenic, mutagenic, or toxic to reproduction), PBT substances (persistent, bio-accumulative, and toxic), and SVHCs (substances of very high concern)25. |
| SCIP Registration | Products with SVHCs above 0.1% by weight need mandatory SCIP registration25. |
| Roles and Responsibilities | Manufacturers, importers, and users must follow REACH rules, including registration, data sharing, SDS creation, and supply chain roles25. |
By staying informed, working with experts, and using the right tools, companies can handle REACH compliance. This ensures they keep accessing the EU market while promoting safer chemical use and environmental protection232425.
Conclusion
The REACH regulation is key to keeping chemicals safe in the European Union. It aims to protect people and the environment26. Even though it has made big steps in chemical safety, its future is unsure. The European Commission might not update it as planned26.
Finding a balance between keeping chemicals safe and helping businesses will be tough. The EU wants to be more sustainable and cut down on carbon emissions26. Companies need to keep up with REACH rules to stay safe and competitive in the EU market27.
As REACH changes, it’s important for everyone to talk openly and share good ideas. Working together can help tackle new challenges27. By focusing on REACH conclusion, chemical safety, and EU regulation, the EU can lead to a better chemical industry. This will protect people and the planet27.
FAQ
What is REACH?
REACH is a European Union rule aimed at protecting people and the environment from chemicals. It makes the EU chemicals industry more competitive and uses new methods to test chemicals without harming animals.
What are the key components of REACH?
REACH means Registration, Evaluation, Authorisation, and Restriction of Chemicals. It makes companies prove and manage the risks of the chemicals they make and sell in the EU.
How does REACH impact businesses?
REACH affects many companies across various sectors, not just those dealing with chemicals. Companies that make, import, or use substances have specific duties under REACH.
What are the procedures under REACH?
REACH sets rules for gathering and checking information on substances’ properties and dangers. Companies must register their substances. ECHA checks these registrations for compliance. If substances are too risky, authorities can ban or limit their use.
What is the REACH review process?
The REACH rule needs regular updates on its goals. The second review in 2018 looked at how well REACH is working. It checked its effectiveness, efficiency, and how it helps the EU.
What are the challenges and controversies surrounding REACH?
REACH’s future is unsure, with the EU Commission not keen on updating it. Balancing chemical safety with supporting the chemicals industry is a big challenge ahead.
How can companies ensure REACH compliance?
Companies need to be proactive to follow REACH. This means identifying and managing chemical risks and sharing risk management with users.
Source Links
- EU REACH Regulation Explained – Eurofins Softlines & Leather
- REACH Compliance: Understanding Electronics Manufacturing Standards
- What is REACH? | Avery Dennison
- Understanding REACH – ECHA
- REACH Regulation
- The Ultimate Guide to REACH Compliance
- Principles of REACH Compliance: Supply Chain Management
- REACH Product Lab Testing: A Complete Guide
- Chemical Reaction: The U.S. Response to REACH
- What Are REACH’s Substances of Very High Concern? – Z2Data
- REACH’s Impacts
- Five Step Guide to EU REACH Compliance
- EU REACH
- REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
- Why the U.S. Is Losing the Fight to Ban Toxic Chemicals
- How to Reach a Safe Circular Economy?—Perspectives on Reconciling the Waste, Product and Chemicals Regulation
- Everything You Need to Know about REACH: How the New Regulations Will Affect the Chemical Industry – Future Bridge Events | Conferences & Summits
- REACH Revision – REACHLaw
- EU quietly shelves REACH regulation on toxic chemicals
- European Green Deal
- The chemical industry may have killed a landmark EU chemical policy. Here’s what that means for the US.
- REACH Compliance Requirements: What the EU’s REACH Regulation Means for Your Business
- Best Practices for REACH Compliance Management for Electronics OEMs – In Compliance Magazine
- REACH Compliance: a Guide for Industrial Manufacturers
- Registration, Evaluation, Authorisation and Restriction of Chemicals – an overview
- FFIEC BSA/AML Developing Conclusions and Finalizing the Exam
