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.

Registration - ECHA. Legislation. REACH Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH regulation aims to improve the protection of human health and the environment from the risks that can be posed by chemicals.

What is a REACH dossier? REACH legislation requires that EU manufacturers and importers submit a registration dossier on the chemical substances that they manufacture or import into the EU in quantities greater than 1 metric tonne per year.

A dossier is a collection of papers containing information on a particular event, or on a person such as a criminal or a spy.

A Regulatory Dossier is like a complete report containing all the important details about a product. It's sent to government agencies to get permission to sell the product. Think of it like an official product handbook that has been painstakingly created.

As a foundation, most dossiers include : ID : this can be in the form of a passport, carte de séjour, or ID card . Proof of residence : think utility bill, the French administration love electricity bills or internet bills . Pay stubs : usually the most recent three for good measure .

Dossier, which emerged in French in the 19th century, is derived from the French word dos, meaning “back.” While the connection between “files” and “backs” isn't certain, it may pertain to the fact that the labels of dossiers were originally affixed to the back, or spine, of each file.

ECHA is the driving force among regulatory authorities in implementing the EU's chemicals legislation. ECHA has to ascertain that companies comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern.

Who needs reach registration? ›

You must comply with REACH if you manufacture or supply articles, or are importing articles from outside the EU. REACH may also apply to a chemical substance you recover from waste in quantities of one tonne or more per calendar year. Some chemical substances are partially or completely exempt from REACH.

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

The technical dossier contains information and data on the substance to be registered and information on risk management measures.

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

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.

: a file containing detailed records on a particular person or subject. the patient's medical dossier.

Registration applications provide comprehensive information about the drug, enabling regulatory agencies to ensure that therapeutic benefits outweigh risks.

A product dossier brings together in one place all the information that the company holds on a product or on 'family' of products. The dossier forms a useful checklist, ensuring that all aspects of the lifecycle have been adequately considered.

Registration (or Register) relates to the importance of precision alignment and placement. Proper registration means that any impression on the paper - ink, metallic foil, embossing, die cut shape, etc. - occurs in the precise position as intended.