Single logo
LoginSign Up

REACH Substance Registration Audit Checklist

A specialized audit checklist for ensuring compliance with REACH substance registration requirements, focusing on dossier preparation, data completeness, and submission processes.

REACH Substance Registration Audit Checklist
by: audit-now
4.6

Get Template

About This Checklist

The REACH Substance Registration Audit Checklist is a crucial tool for chemical manufacturers and importers to ensure compliance with the European Union's REACH regulation. This specialized checklist focuses on the complex process of substance registration, a cornerstone of REACH compliance. By meticulously reviewing registration dossiers, data requirements, and submission processes, companies can minimize regulatory risks, safeguard market access, and demonstrate their commitment to chemical safety and environmental stewardship.

Learn more

Industry

Chemicals

Standard

REACH - Registration, Evaluation, Authorization of Chemicals

Workspaces

Laboratories
research and development facilities
Office Buildings

Occupations

Regulatory Affairs Specialist
Toxicologist
Ecotoxicologist
Chemical Safety Assessor
REACH Consultant

1
Is the substance properly registered under REACH?

Select the compliance status of the substance registration.

To ensure compliance with REACH registration requirements.
2
Have all chemical data requirements been analyzed for the substance?

Provide details of the analysis performed.

To verify that all necessary chemical data has been assessed.
3
What is the score for the data gap analysis performed?

Enter the score (0-100) indicating the level of data gaps identified.

To evaluate the completeness of the substance dossier.
Min: 0
Target: 0
Max: 100
4
Is the company participating in a joint submission for the substance?

Select the participation status.

To confirm participation in a SIEF for compliance.
5
Please provide a summary of the chemical safety assessment conducted.

Detail the findings and recommendations from the chemical safety assessment.

To document the safety assessment findings.

FAQs

This checklist specifically focuses on the substance registration process under REACH, including dossier preparation, data requirements, and submission procedures.

It should be used by regulatory affairs specialists, toxicologists, ecotoxicologists, and other technical experts involved in preparing and submitting REACH registration dossiers.

The checklist includes sections to review required data for different tonnage bands, helping identify missing information in physicochemical properties, environmental fate, ecotoxicology, and toxicology studies.

Yes, the checklist is designed to be applicable for both new substance registrations and updates to existing registration dossiers, ensuring comprehensive coverage of REACH requirements.

The checklist includes items to verify proper participation in Substance Information Exchange Forums (SIEFs), data-sharing agreements, and joint submission processes as required by REACH.

Benefits

Ensures thorough preparation and completeness of substance registration dossiers

Helps identify and address data gaps in physicochemical, toxicological, and ecotoxicological information

Reduces the risk of registration rejections or non-compliance findings

Facilitates efficient collaboration between technical experts and regulatory affairs teams

Supports continuous improvement in substance data quality and management