REACH imposes a general obligation that testing on vertebrate animals for the purposes of this Regulation shall only be undertaken as a last resort. If data is obtained through testing on vertebrate animals, it will be subject to the data protection and data sharing provisions, which seem to differentiate between data involving the use of vertebrate animals submitted for "phase-in" substances and such data submitted for non "phase-in" substances.
For non "phase-in" substances, vertebrate animals data are protected for 10 years after the registration, and a prospective registrant can only obtain access to the market if it first obtains a letter of access from the data owner. The prospective registrant and the data owner are required to take all reasonable steps to reach an agreement on the sharing of vertebrate animals data. In case of failure to agree, the prospective registrant will have access to the data upon payment of 50% of the cost incurred by the data owner.
For " phase-in" substances, the "pre-registration" data, which are to be submitted at least 18 months prior to the deadline for registration, will be made available to other companies who have submitted information on the same substance, and to Member State Competent Authorities. In addition, companies that provide these data are participants in the Substance Information Exchange Forum ( SIEF). Companies may communicate within SIEF and must take all reasonable steps to reach an agreement regarding the performance of new studies.
Issues of concern
With respect to existing studies for "phase-in" substances, it is unclear whether the participants within SIEF who already own vertebrate animal testing data are obliged to provide it to the other participants. (See Point 31 of the Regulation.)
The Regulation imposes mandatory sharing for vertebrate animals data submitted for the registration of non-"phase-in" substances. A prospective registrant must pay 50% of the "cost incurred" by the previous registrant. It is not clear whether this includes the costs for the external technical or legal assistance, or for the manpower used to compile and file the registration. It seems that, in any case, the "cost incurred" would not include a "risk premium" and/or an inflation adjustment. Further, the previous registrant must provide information on the "cost incurred" within one month from failure to reach an agreement with the prospective notifier. For data owners obligated to provide accurate and reliable information on the cost incurred for the data in question, the one-month deadline may pose significant problems.
Manufacturers of phase-in substances which are marketed in quantities below 1 tonne, and are therefore exempted from registration, may submit "pre-registration" data. Presumably, this should enable them to sell these data to registrants.
In order to obtain the confidential treatment of confidential business information (CBI) submitted under the draft REACH Regulation, the registrant, downstream user, applicant or any other party concerned must make a specific request to the Member State Competent Authorities, and must demonstrate that disclosure of the data could harm him commercially. Certain data do not qualify for treatment as CBI, such as (a) the trade name(s) of the substance, (b) the name and address of the registrant, downstream user, applicant, manufacturer or importer, (c) physicochemical data concerning the substance and on pathways and environmental fate, and (d) the result of each toxicological and ecotoxicological study, if essential to classification and labeling.
Issues of concern
Protection of confidentiality of data is granted only if "justified", and is not possible for certain specific data. It is not clear if a negative decision from the Member States' Competent Authorities (i.e., a denial of CBI status) can be challenged.
(The provisions related to data protection and data sharing are included in Points 26 to 31 of the Regulation. The provisions related to confidentiality are included in Point 102 of the Regulation.)
Last Updated: May 2003