REACH: Information to be submitted in the technical dossier depending on tonnage
REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
Vertebrate animal tests should be avoided and replaced by alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship (QSAR) models or information from structurally related substances (grouping or read-across).
Furthermore testing may be omitted where justified by information on exposure and implemented risk management measures.
The REACH Annexes specify that:
* Regarding the information required for substances manufactured or imported in quantities of 100 t/a and 1000 t/a or more, a proposal and time schedule for fulfilling the information requirements shall be submitted first.
* Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.
* Before new tests are carried out to determine the properties listed, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided.
* In the tables listing the required information on this website, selected specific rules are listed specifying the requirements or stating under what circumstances the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way.
(For a complete list of the specific rules, refer to the REACH text.)
* In addition to these specific rules, a registrant may propose to adapt the required standard information according to the general rules contained in Annex XI.
Conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) also apply.