REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is a regulation in the European Union that requires manufacturers to make sure their products are safe and to provide detailed information on the substances they contain. The regulation, which restricts the levels of certain chemical substances in imported goods, is designed to protect human health and the environment from any potential dangers posed by chemicals used in consumer products.
All goods imported into the EU, as well as all substances manufactured in the EU, must comply with the REACH regulation. In this article, we will review REACH compliance requirements and best practices for achieving compliance.
The REACH Regulation (EC 1907/2006) is a European Union (EU) law introduced in 2006 that seeks to improve the protection of human health and the environment from the risks posed by hazardous chemicals. It does this by increasing transparency and knowledge gathering around chemical substances used within the EU and, ultimately, reducing their use by promoting the introduction of safe alternatives.
It is essential that companies ensure compliance across their operations to avoid financial and legal penalties and recalls. The key elements of REACH compliance are for companies to register details of all chemical substances they manufacture or import into Europe in quantities above 1 tonne per year; assess any potential risks to human health or the environment associated with these substances; and provide safety information about them so that other companies can use these chemicals safely.
The regulatory body, the European Chemicals Agency (ECHA) publishes and regularly updates a list of restricted substances. These chemicals require authorization from the ECHA before they can be used in a product in the EU or imported into the EU. This includes Substances of Very High Concern (SVHCs), which are substances that may be carcinogenic, mutagenic, toxic to reproduction, or bioaccumulative. There is a 0.1% of total product weight limit for each of the SVHCs that applies to all product types.
REACH impacts companies across a variety of industries based in the European Economic Area (EEA). This includes:
Manufacturers of chemicals in the EU, including chemicals they will export
Importers of individual chemicals, mixtures, or finished products into the EU
Downstream users who use chemicals in their products or processes
Distributors who source and sell products within the EEA
Your company may have multiple roles, so it’s important to understand which roles apply to you in order to understand your obligations under REACH.
Companies outside the EU are not required to comply with REACH, even if importing products into the EU. Instead, responsibility for compliance with REACH lies with importers of their products into the EU, or with the only representative (someone who takes over the responsibility of compliance under REACH for a company based outside the EEA).
Compliance with the REACH regulation is critical as it ensures that your products are safe and can be sold in the EU. There are numerous benefits to compliance:
Avoidance of financial penalties and legal action: Companies that fail to comply with REACH regulations may face hefty fines and potential lawsuits from customers or authorities. While each EU Member State defines its own penalties, fines can range up to USD$130,000 per violation. Additionally, authorities may issue recalls of non-compliant products, leading to significant financial losses.
Reduced risks: You can avoid potential liabilities from non-compliance. For example, in case of injury due to hazardous chemicals present in your products, you may be liable if those chemicals have not been properly assessed and regulated under REACH.
Improved reputation: Non-compliance can result in bad publicity, leading to reduced consumer trust and lower customer loyalty. Adhering to REACH guidelines helps build trust with customers and stakeholders, as it demonstrates a commitment to sustainability and ethical practices.
Access to markets: Compliance with REACH is required in all EU Member States, as well as Iceland, Lichtenstein, and Norway. By ensuring compliance with REACH requirements, you ensure you can sell your products in these lucrative markets.
REACH compliance can be broken down into several steps.
The first step to ensuring REACH compliance is assessing your supply chain and products for use of chemicals restricted by REACH. This involves collecting information from suppliers to determine whether restricted chemicals are used, and if so, in what amount. The REACH regulation does not require information to be presented in a standard template. Instead, this information can be reported by suppliers via Full Materials Declarations (FMDs), certificates, safety data sheets, and test reports.
Substances may be restricted by REACH through total bans (such as asbestos) or through threshold limits for the amount of certain substances allowed in certain products. Many companies, such as importers of finished goods, undergo testing at this stage to assess the potential restricted substances present in their products. Testing allows you to verify the presence and amount of a wide range of substances restricted by REACH.
For many companies, the next step of REACH compliance is registration with the ECHA. REACH Article 6(1) states that any manufacturer or importer who produces or imports more than 1 tonne of a substance (on its own or in a mixture) per year must register with the ECHA. This registration process includes providing information on the identity of the substance and its intended use; a chemical safety assessment that provides evidence of safe handling; and an exposure scenario for each phase in production, manufacturing, use, or disposal. Certain SVHCs may require authorization or face restrictions. If your substance is listed, you must seek authorization to continue using it or find suitable alternatives.
Several other obligations follow after registration, such as communicating your registration number to customers if you are not required to supply a safety data sheet. This helps customers access potential safety data about your product.
The 1 tonne/year limit has increased the difficulty of REACH compliance, as many companies quickly exceed this limit. This can even include companies that may not realize they exceed the limit, including:
Global companies that ship products around the world
Non-chemical industries that still use large volumes of chemical products, such as the automotive industry
Companies that have previously undergone REACH threshold assessments and believe themselves to be under the limit, but who undergo a merger or other change in operations that increases production
Once a registration dossier has been submitted to the European Chemicals Agency (ECHA), it is evaluated to ensure that it meets the requirements of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. The evaluation process includes an assessment of the hazard and risk information provided, as well as a review of the dossier's completeness and accuracy.
ECHA may request additional information or testing. It is important to cooperate with ECHA and provide any additional data that is requested. This will help to ensure that the evaluation process is completed as quickly and efficiently as possible.
Effective communication within the supply chain is vital for REACH compliance. Companies must provide Safety Data Sheets (SDS) to downstream users, containing comprehensive information about substance properties, handling, and safety precautions. Ensure accurate and up-to-date SDSs are readily available. Additionally, maintain open communication with suppliers and customers to exchange relevant information, such as changes in substance composition or classification.
REACH regulations and requirements evolve over time. Many companies choose to work with a third-party expert to stay informed about the latest amendments, updates, and deadlines to maintain compliance. These experts stay up to date with the latest regulatory updates and can review your registration dossiers to address any changes in substance volumes, uses, or compositions promptly.
The full text of the REACH regulation includes over 140 Articles explaining various requirements for compliance for different types of operations and products. For example, some chemicals or uses may be exempt or partially exempt, such as radioactive substances or substances used in medicinal products. Thus, it may be difficult to determine all the compliance requirements that apply to your business or product in particular.
Our regulatory experts at QIMA can help you understand and ensure compliance with all relevant requirements under REACH. The expert will have in-depth knowledge of all requirements to help you ensure comprehensive compliance.
Our global network of testing laboratories can assess a wide range of products for the presence of restricted substances to help you ensure compliance. Our regulatory knowledge, coupled with our state-of-the-art laboratories, allows us to guide you through the REACH compliance process from start to finish.