Understanding REACH Compliance in the EU

Objectives

The EU parliament recognizes the danger chemicals pose to people, wildlife, and the environment. With continued production and use of these hazardous compounds, the body agreed to develop the Community Policy for Chemicals. It led to the proposal for REACH, which was ratified on December 18, 2006, and came into effect on June 1, 2007. These are some of the goals of the directive:

• Protect human health and the environment by determining the harmful properties of chemicals used in the region.
• Phase out hazardous chemicals or “substances of high concern” and search for safer alternatives.
• Encourage companies to discover safer alternatives, maintaining their competitiveness in the market.
• Foster innovation in the chemical industry and promote the development of new, safer chemicals.
• Reduce chemical testing on animals and find alternative methods for hazard assessment on substances.

Since its enactment, the regulation has undergone several updates and revisions, enhancing transparency and improving evaluation processes. The most recent ECHA amendment, which took effect in July 2021, improved the predictability of the process and clarified the information that companies need to submit.

Benefits to Companies

REACH has placed the responsibility of risk management on the shoulders of the industry. Although this is a challenging endeavor, given that it entails changing numerous facets of the operations, it offers numerous advantages to companies:

• Improved Market Access – Compliant companies can freely produce and market their products within the region, improving their bottom line.
• Enhanced Risk Management – Because the regulation entails stricter risk identification and mitigation of hazardous substances, companies can prevent accidents and related liabilities.
• Increased Competitive Advantage – Commitment to sustainability standards enhances the company’s reputation, making it more attractive to an increasingly environmentally-conscious general public.

Stakeholder Responsibilities

REACH mandates companies to determine the dangers associated with their operations, eliminate or minimize the use of these chemicals, and uphold the best practices for safe and sustainable production and usage.

Because chemical production and use are extensive, the regulation affects a wide range of industries:

• Manufacturers of chemicals amounting to one tonne or more per year in the EU, including products for export
• Importers of individual chemicals, mixtures, or finished products into the EU, amounting to one tonne or more annually
• Downstream users or companies that use chemicals in their processes or products
• Distributors that source and sell products within the European Economic Area (EEA)

The duty of how to determine REACH compliance falls under the purview of these teams within the company:

• Regulatory affairs administrators oversee conformance with any regulation or standard and prepare REACH compliance documents for submission.
• Environmental, Health, and Safety (EHS) managers ensure chemical safety practices are developed and enforced.
• Product safety directors handle the actual safety aspects.
• Supply chain supervisors coordinate with suppliers, ensuring their partners adhere to the regulations.

REACH Compliance Process

There is no doubt that the REACH regulation is a challenge for many organizations. However, ECHA’s continued efforts to streamline their process ascertain that companies can comply with ease. Here is a simple guide that can help HSE managers, quality directors, and operations supervisors when gathering REACH compliance requirements:

Data Collection

This is not necessarily a part of the REACH process. However, this is the first step companies should undertake to assess the chemicals used in their operations and by their partners.

Best Practices:

• Get familiarized with how ECHA categorizes chemicals (e.g., phase-in substances, notified substances, substances of very high concern, multi-constituent substances, dangerous substances, and restricted substances)
• Conduct the necessary tests and audits based on the categories noted above.
• Use digital checklists when performing these activities to reduce mistakes and ensure the accuracy of reports.

Registration

This step involves collecting comprehensive data about the properties of the chemicals the company uses, the possible risks associated with their use, and the ways to handle them safely. The requirements listed below should be submitted to ECHA via the REACH-IT portal.

Requirements:

• Technical dossier of the chemical that includes composition, structure, and purity.
• Summary of the chemical’s properties (e.g., physical-chemical, toxicology, eco-toxicology)
• Classification and labeling details
• Guidance on safe use
• Chemical safety report (if quantities exceed 10 tonnes per year)
• Detailed risk assessment

Best Practices:

• Utilize the IUCLID (International Uniform Chemical Information Database) software to help prepare the technical dossier. It ensures that submissions are comprehensive, up-to-date, and accurate.
• Collaborate with partner companies for data sharing. Doing this also reduces costs.
• Start the data collection process early because some substances require extensive testing.

Evaluation

ECHA will scrutinize the documents handed over by companies. Evaluation ensures that the information initially submitted is adequate. The agency also ascertains effective risk management and mitigation. If the agency finds the dossier is lacking, they will ask for the following:

Requirements:

• Specific data requested by ECHA if they deem the first report insufficient
• Clarifications or supplementary information

Best Practices:

• Regularly review and update the dossier, ensuring it reflects new information or changes in the use and manufacture of substances.
• Maintain open communication with ECHA in preparation for requests for further testing or additional data.

Authorization

The next step ensures that Substances of Very High Concern (SVHC) are controlled or progressively replaced. If the company uses chemicals categorized under this list, relevant managers should file an application demonstrating proper risk control. If they find no suitable alternative, the document should also show that socio-economic benefits outweigh the risks.

Requirements:

• Authorization application, including analysis of alternatives, substitution plan, socio-economic analysis, and chemical safety report
• Exposure scenario

Best Practices:

• Engage stakeholders to gather as much information to support the application.
• Explore potential alternatives to SVHCs as early as possible.

Restriction

This limits or prohibits the manufacturing, marketing, and use of substances that pose unacceptable risks to human and environmental health. Sometimes, the restriction is lenient, going as far as setting technical measures or some form of hazard communication. Whatever it will be, the company should abide by it or suffer the consequences.

Requirements:

• Justification for restriction (e.g., hazard data, exposure information, and risk assessments)
• Socio-economic impact assessments
• Analysis of alternatives and feasibility of implementation

Best Practices:

• Stay updated on potential restrictions under EU guidelines.
• Develop plans related to the changes, including communication with suppliers and customers.