Registration Dossier - ECHA (2024)

FAQs

What is a registration dossier? ›

The registration dossier includes a description of the uses of the substance, the physico-chemical, ecotoxicological and toxicological properties, and a hazard and risk assessment showing how the risks posed by the use of the substance are controlled.

The file that you submit to ECHA to register your substance is called a dossier. A dossier is a read-only copy of your substance dataset, complemented with information about the type of your registration.

The best way to verify the validity of a REACH registration number is to look at the original submission report issued by ECHA. On the report, you can find registration number, registered tonnage band and registrant's name.

The REACH registered substance factsheet is a dissemination tool introduced by the European Chemical Agency (ECHA) to publish information from Agency's registered substance database.

Dossier just means “a collection of documents about the same topic.” Dossiers are typically meant to provide comprehensive, detailed information about a subject.

A dossier consisted of (1) a synopsis containing a substance's physicochemical characteristics, manufacturing processes, production, intended and other uses, chemical fates, exposure potentials, and all retrieved information deemed by the NRC staff to be relevant; (2) a list or lists of the adequacy ratings of required ...

Dossier allows you to store all of the critical information tied to the executive you support in one central location.

Dossiers are submitted to the Regulatory Authorities to support all applications from clinical trials to marketing authorisation (licensure) and post-approval variations. The various components of the. documentation used to support.

REACH applies to you if your business is:

a manufacturer - you make chemicals for sale by your company or for supply to others. an importer - you buy individual chemicals, mixtures of chemicals or products such as clothes, furniture or plastic goods from outside the EU.

How long does REACH registration take? ›

The inquiry process takes 1-2 months and the whole registration process might take up to 12 months.

The European Chemicals Agency (ECHA) works for the safe use of chemicals.

Making REACH work the chemical industry's priority

More than 20,000 substances have been registered with ECHA, with corresponding physico-chemical, toxicological, ecotoxicological and use data, thereby creating the largest and most comprehensive database on substances, their properties and behaviour in the world.

ECHA CHEM is ECHA's new public chemicals database launched in early 2024. Initially, it includes data that companies have submitted in their REACH registrations. Over the coming years, ECHA will gradually transfer the data it makes publicly available from their current location (Search for chemicals) to ECHA CHEM.

On 23 January 2024, the European Chemicals Agency (ECHA) published the 30th update of the REACH Candidate List¹. Five (5) new Substances of Very High Concern (SVHC) were added, and the property of one substance was updated. Now, the Candidate List includes 240 SVHCs².

Registration Dossier means a written regulatory submission or document describing Product Specifications and manufacturing methods as submitted by Company and approved by the applicable regulatory agency and Distributor.

The purpose of Drug Registration is to ensure that a pharmaceutical product has been adequately tested and evaluated for safety, efficacy and quality, and that the product information provided by the manufacturer is accurate.

A specimen is a sample of your trademark as used in commerce . It is real-life evidence of how you are actually using your trademark in the marketplace with the goods or services in your application or registration maintenance filing.

INTRODUCTION: A dossier is a file submitted for drug product approval in various regulatory countries. It is presented in harmonized formats like CTD, e-CTD, and ACTD, following ICH region guidelines. In case of Generic drug products are comparable to innovator drug products in certain cases.