The EU REACH is the most important regulatory framework governing chemicals in Europe. REACH, which stands for Registration, Evaluation, Authorization, and Restriction of Chemicals, is an effort by the European Union to enhance its environmental and human health protection. Under the regulation, companies are responsible for reporting on chemical substances used in the EU. Businesses, importers, and users must register all manufactured or imported substances that exceed one ton per year.
The objective of registering chemicals is to make sure that information regarding the safety of each substance is publicly available. REACH also fosters innovation and competitiveness in the chemical industry. The regulation encourages companies to discover safer alternatives to the most dangerous chemicals on the market. Companies must stay abreast of regulations and updates to the most recent chemical production guidelines in order to avoid legal risks, operate in compliance with regional laws, and stay competitive.
REACH: History & Background
In 2001, the European Commission laid the groundwork for the adoption of a Community Policy for Chemicals. Only two years later, the Commission presented the initial proposal of REACH to the EU Parliament and Council. The primary committees that participated in the EU parliament evaluation process were the Committee on Environment, Public Health and Food Safety (ENVI), together with the assistance of nine other committees. The EU Commission, European Parliament, and Environment Council approved the final version of the REACH agreement in 2006, and the regulation came into effect in 2007. A year after the European Union adopted the REACH directive, the new specialized European Chemicals Agency (ECHA) started its operations. The branch enforces the agreement and serves as a body responsible for ensuring the proper registration and re-registration of dossiers. ECHA also evaluates the information provided by companies.
The Rationale behind REACH
The main objectives of REACH are to protect the health of European citizens and ensure a safe environment. The regulation attempts to discover potentially harmful properties of various chemical elements and substances used in the EU. REACH also intends to find an effective replacement for the substances of high concern. Hazardous chemicals with the most significant environmental and health impacts will be phased out in the long run with the help of up-to-date information from the dossiers.
The European market in the early 2000s was flooded with thousands of unregistered chemical substances, often in large amounts. As a result, to understand the risks that chemicals pose to the environment and human health, the EU legislative body had to take action. The REACH regulation also helps companies to properly evaluate the safety of the materials they use and take appropriate risk management measures. The regulation specifically highlights the rule “no data no market”, which puts the responsibility on the industries to ensure the provision of the most accurate information on the chemicals utilized in the EU.
What does REACH stand for?
Businesses must present relevant information about the properties and uses of the chemicals they are producing or importing. The registration is only relevant for companies that employ a particular substance in significant quantities, specifically above one ton a year. A business must identify the potential risks of the chemical and ways to mitigate them. Registration of a chemical is done through the filing of a dossier containing relevant information about the chemical’s hazards and control measures. A company must write a dossier on individual substances, ones in mixtures, and sometimes substances in articles. However, there are some exceptions to this rule; for example, businesses do not have to register certain types of medicine and radioactive substances. Manufacturers and producers must cooperate to submit one dossier per substance.
The information provided by the manufacturers must be accurate and up-to-date. Registered chemical substances may only be used or imported if their dossiers contain relevant information. The bodies responsible for the evaluation are ECHA and the EU Member States. They evaluate the credibility of the data presented in the dossiers to ensure a substance does not pose any risks to the environment or human health. The process analyzes the testing recommendations, assesses the dossier’s compliance, and evaluates the substance. After the assessment, ECHA might require companies to provide additional information on a given chemical.
After ECHA identifies substances of very high concern (SVHCs), the process of authorization develops ways to substitute them with less dangerous alternatives. The Candidate List contains all SVHCs that are currently under consideration for restriction in the Annexes of the Regulation. The properties that constitute the hazardous nature of the substance include chemicals falling under the carcinogenic, mutagenic, or toxic for reproduction (CMR) category, as well as persistent, bioaccumulative, and toxic (PBT), counting very persistent and very bioaccumulative (vPvB) substances. However, chemicals can be classified as SVHCs on a case-by-case basis.
After ECHA declares a chemical dangerous, a company must fulfill a series of obligations. The agency also publishes an official Authorization List intended to regulate the use of SVHCs. Periodically ECHA reviews the substances on its Candidate List, and if the agency deems a substance sufficiently dangerous, the experts place it on the Authorization List. The information from the European Chemicals Agency indicates that producers or importers who want to use or sell substances on the list must apply for authorization.
Restriction of Chemicals
After careful consideration of every substance, restrictions are imposed on those posing immediate harm to human well-being or the environment. The restrictions may take the form of a complete ban on the production or import of a substance, or the implementation of specific measures to minimize harm. Restrictions can be applied to the individual substances, a mixture of chemicals, or in an article. If a substance is used for scientific purposes, employed as an on-site intermediate, or regarded as risky only when used in cosmetics, it is excluded from the REACH restrictions.
2022 REACH Updates
The European Commission proposed revisions that companies should refer to while registering substances under REACH. The new changes will be effective in October 2022, and companies should begin planning for the transition. The main goal of the revision is to ensure transparency and improve the predictability of ECHA’s evaluation practices. After familiarizing themselves with the changes in the annexes, businesses should prepare to review the dossiers accordingly.
The main changes concern the following:
- In vitro and in vivo mutagenicity studies;
- reproductive toxicity studies;
- aquatic toxicity studies;
- toxicity studies on terrestrial and sediment organisms;
- degradation and bioaccumulation studies;
- the obligation for only representatives to provide details on the non-EU manufacturer they represent;
- changes in substance identification information requirements; and
ECHA is currently updating its guidance materials, and the agency plans to publish resources related to information requirements for registrants in the second half of 2022. ECHA will provide additional information on the official website as more details become available.
Company Requirements under EU REACH
The EU REACH regulation requires companies to register the chemical substances they import or manufacture in the European Union. Notably, the aim is to keep track of potentially hazardous chemicals and reduce their use in the EU. When companies use chemicals from the Candidate List, they must disclose this information to the ECHA and consumers. Depending on the case, the business has to provide safe-use instructions while selling the product containing the chemical. However, if the substance is on the Authorization List, the only way for companies to use the chemical is by directly approaching the ECHA and receiving a special approval.
Сompanies must always consult the list of restricted substances to determine whether their products contain any chemicals that are currently under the SVHCs umbrella. Notably, the composition of some products may be affected by the restriction or banning of a substance. The new updates to REACH are also crucial to consider, as they may impact the registration process of certain substances.