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Information requirements for the technical dossier for registration


The technical dossier contains information on the properties and classification of a substance as well as on uses and guidance on safe use.

Information on the intrinsic properties of a substance to be registered

Under REACH, registrants are obliged to collect all available relevant information on the intrinsic properties of a substance to be registered, regardless of the quantity manufactured or imported. However, the type and quantity of information that is required as a minimum to meet the obligations of the REACH regulation depends on the quantity that is manufactured or imported into the European Union. Annexes VII to X of REACH specify the minimum data requirements for a given substance according to its tonnage.




PC, toxicological and ecotoxicological information

Physico-chemical properties (PC)

Toxicological and ecotoxicological information

PC, toxicological and ecotoxicological information

Toxicological and ecotoxicological information


All available relevant data

Annexe VII requirements

Annexe VII

Annexe VIII

Annexe IX

Annexe X

1-10 t/y





10-100 t/y



100-1000 t/y



≥ 1000 t/y



1. For the lowest tonnage band (1 to 10 t per year per manufacturer or importer), the required minimum information is confined to the physico-chemical data:
- if the substance is a “phase-in substance”, i.e. a substance already manufactured or imported, under certain conditions, before the entry into force of REACH on 1 June 2007 and,
- if the substance is predicted not likely to meet the criteria for category 1 or 2 classification for carcinogenicity, mutagenicity or reproductive toxicity and the PBT or vPvB criteria (PBT: persistent, bioaccumulative and toxic - vPvB: very persistent and very bioaccumulative) and,
- the substance does not have a dispersive or diffuse use and it is predicted not likely to meet the criteria for classification for any human health or environmental hazard.
2. At this level, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this annexe.

As each new tonnage level is attained, the requirements of the next corresponding REACH annexe must be addressed.
Column 1 of REACH annexes VII to X lays down the standard information requirements (see table REACH standard information requirements). These standard requirements may however be adapted (waived or increased), when appropriately justified. For each of the REACH annexes VII to X, column 2 lists specific rules for adaptation (e.g. exposure or hazard characteristics), according to which the standard information requirements may be modified.
In addition to these specific rules, the required standard information set may also be adapted according to the general rules contained in annexe XI of the REACH regulation e.g. in cases where testing is not technically possible, or testing does not appear scientifically necessary, or based on exposure considerations.

Exposure information

Information on the manufacture (if within the European Union), use, handling and disposal of the substance (i.e. covering its whole life cycle) or of articles containing the substance, should be gathered to obtain insight into populations and compartments exposed, as well as the nature of the exposures, i.e. route, frequency and duration (annexe VI of REACH, sections 3 and 5 and, for substances in quantities between 1 and 10 tonnes per year per registrant, annexe VI, section 6).

This information guides data requirements on the intrinsic properties of a given substance: e.g. if limited and well controlled human exposure is only taking place at the workplace during a few days a month, long-term repeated toxicity studies may not be needed.

For substances manufactured or imported in quantities between 1 and 10 tonnes per year and per manufacturer/importer, this information will be used to conclude on dispersive or diffuse use of the substance.

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Prévention du risque chimique, France, 2007
This document is provided for information only and under no circumstances constitutes legal advice. The only authentic legal reference is the text of the REACH Regulation (Regulation (EC) n° 1907/2006).