REACH: Simplifying the Complex World of Chemical Safety

The European Union’s REACH regulation—Registration, Evaluation, Authorisation and Restriction of Chemicals—is widely regarded as one of the most comprehensive and demanding frameworks governing chemical safety anywhere in the world. Enforced by the European Chemicals Agency (ECHA), REACH ensures that chemicals used in industrial and commercial applications do not pose unacceptable risks to human health or the environment.

For companies working with active pharmaceutical ingredients (APIs), chemical intermediates, specialty chemicals, or materials used in medical and technical applications, REACH compliance is not just a legal necessity—it is a gateway to market access, supply chain credibility, and long-term sustainability.

Yet the regulation’s scope and complexity are significant. Simplifying REACH requires both a clear understanding of its structure and a strategic approach to compliance—one that many organizations achieve through partnerships with experienced CRDMOs.

REACH places the responsibility of chemical safety squarely on manufacturers and importers. Any chemical substance manufactured or imported into the EU in quantities above 1 tonne per year must register it with ECHA. The registration dossier must demonstrate that the substance can be used safely throughout its lifecycle. Key components of a registration include:

• Substance identity and properties

• Hazard and safety data

• Risk assessments for human health and the environment

• Guidance on safe handling and intended uses

Navigating REACH independently can be resource-intensive and complex. That is why partnering with a CRDMO (Contract Research, Development, and Manufacturing Organization) offers strategic value.

A REACH-ready CRDMO provides:

• Regulatory Strategy and Support: Guidance on substance classification, dossier preparation, and ECHA submissions
• Advanced Analytical Capabilities: Comprehensive testing for physicochemical properties, impurity profiling (including genotoxic impurities), extractables & leachables studies, and toxicological assessments.
• Integrated Compliance in Development: Ensuring from pre-clinical research through scale-up manufacturing that each step aligns with EU safety standards.
• Tailored Client Solutions: Whether you need a single substance registration, multi-tonnage band submission, or lifecycle management of large chemical portfolios.
• Lifecycle Safety: Ongoing updates as ECHA regulations evolve, ensuring that existing registrations remain valid and compliant.

While these steps are clearly defined, executing them efficiently requires scientific, regulatory, and operational expertise.

One of the essential steps in meeting REACH requirements is registering chemicals with ECHA, which involves providing detailed safety data generated through testing, as outlined in Annexes VII to IX of the REACH regulation. These annexes define the necessary testing based on the quantity and potential hazards of a substance.

For chemicals produced or imported in quantities from 1 to 10 tons per year, Annex VII focuses on basic safety assessments, including:

• Acute Toxicity (oral, dermal, inhalation)
• Skin and Eye Irritation
• Sensitization (allergic reactions)
• Genotoxicity (mutations, cancer risks)
• Environmental Fate (persistence, bioaccumulation)

For chemicals produced or imported in quantities of 100 tons or more per year, Annex IX requires the most extensive testing, including those listed under Annex VII and Annex VIII, and below:

• Long-Term Toxicity
• Neurotoxicity (including developmental neurotoxicity)
• Endocrine Disruption
• In-Depth Ecotoxicology (soil, water, ecosystems)

Given the technical complexity and evolving nature of REACH, many companies turn to Contract Research, Development, and Manufacturing Organizations (CRDMOs) to manage compliance efficiently.

A REACH-experienced CRDMO offers integrated support across the chemical development lifecycle, including:

• Regulatory Strategy and Planning
• Guidance on substance identification, data requirements, use scenarios, and dossier strategy.
• Comprehensive Testing and Analysis
• Including impurity profiling, genotoxic assessments, extractables & leachables (E&L), and in vitro toxicology, often using OECD-compliant methods.
• Dossier Preparation and Submission
• Managing IUCLID files, REACH-IT communication, and registration timelines with full regulatory oversight.
• Consortium Coordination and Data Sharing
• Supporting joint registration, cost-sharing agreements, and negotiation with lead registrants.
• Ongoing Compliance Management
• Monitoring regulatory updates, revising dossiers, and supporting customer audits or inspections.

REACH is undeniably complex, but partnering with a REACH-ready CRDMO helps clients:

• Enter the EU market faster and with fewer risks
• Avoid delays caused by missing or non-compliant data
• Streamline documentation and reduce regulatory overhead
• Focus internal resources on core R&D and innovation
• Support ESG commitments through safer, compliant product development

This turns regulatory compliance from a cost center into a strategic advantage.

REACH is undeniably complex, but with the right expertise and systems in place, it becomes manageable—even strategic. By combining scientific expertise, state-of-the-art analytics, and regulatory insight, a CRDMO simplifies chemical safety compliance and protects client programs from costly disruptions. This ensures clients remain focused on what they do best—driving innovation and delivering safer products to global markets.

At INTOX, an Aragen company, we combine deep regulatory knowledge, scientific rigor, and operational efficiency to simplify your REACH compliance journey. From initial substance identification to final dossier submission and lifecycle updates, we support your goals of safe, compliant, and competitive product development.

Our comprehensive suite of toxicology testing services is designed to support your safety assessments across various industries. We offer:

• General Toxicology Studies: Assess overall health risks posed by chemicals.
• Developmental and Reproductive Toxicology (DART): Evaluate potential effects on reproduction and fetal development.
• Inhalation Toxicology: Study how chemicals affect respiratory health when inhaled.
• Skin Studies: Test for irritation, corrosion, and sensitization potential.
• Phototoxicity Studies: Determine if substances become harmful when exposed to light.
• Genetic Toxicology: Assess whether chemicals can cause DNA damage or mutations.
• Ecotoxicology Studies: Evaluate environmental impact on aquatic life, plants, and soil organisms.
• Endocrine Disruptor Screening (EDSP): Identify chemicals that interfere with hormonal systems.
• Environmental Fate (eFate) Studies: Analyze how chemicals behave in the environment (e.g., degradation rates).
• Analytical Chemistry Services: Provide precise measurements of chemical composition.

Contact us today to learn how we can help you meet REACH requirements and unlock opportunities in the EU and beyond.