EU REACH Regulation (Regulation (EC) No 1907/2006)
Title III: Data sharing and avoidance of unnecessary testing – EU REACH Regulation (Regulation (EC) No 1907/2006)

EU REACH Regulation (Regulation (EC) No 1907/2006) 27: Share existing data on fair, transparent and non-discriminatory terms; vertebrate studies must be requested, not repeated

What does 27 require?

For a substance registered less than 12 years earlier, a potential registrant must request from the previous registrants the information involving vertebrate tests it needs (and may request other information), and both sides must make every effort to agree on sharing and on costs determined in a fair, transparent and non-discriminatory way, paying only for information needed for their own registration. On agreement, the previous registrant makes the information available and gives permission to refer to the full study report. If no agreement is reached, the potential registrant informs the Agency and the previous registrants at the earliest one month after receiving their names, and the Agency may grant permission to refer subject to proof of payment of a share of the cost. Within substance information exchange forums, a participant must ask for existing vertebrate studies before testing, the study owner must provide proof of cost within a month, only one study is carried out per information requirement on behalf of all, and an owner who refuses to share is penalised.

Maintained by Gerard Blokdyk

Other controls in Title III: Data sharing and avoidance of unnecessary testing – EU REACH Regulation (Regulation (EC) No 1907/2006)

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