Guidance on data sharing - ECHA - Europa

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48 <strong>Guidance</strong> on data sharing Version 2.0 April 2012 3.3.3.1 Step 1: Individual gathering of available information Potential registrants should first gather all existing available information on the substance they intend to register. This must include both data available “in-house”, as well as that from other sources, such as data in the public domain that can be identified through a literature search. The search, identification and documentation relating to “in house” information must remain an individual exercise and companies have been encouraged to conduct this data gathering exercise well ahead of the SIEF/data sharing phase, and even before the pre-registration phase as the availability of the data (or lack thereof and therefore the cost of generating the required data) may have been one of the elements which could influence the decision to become a potential registrant for that substance. NB: Data gathering must be thorough, reliable and well documented, as failure to collate all of the available information on a substance may lead to unnecessary testing with related resource implications. The information to be gathered by each potential registrant must include all information relevant for purposes of Registration, i.e.: • Information on the intrinsic properties of the substance (physicochemical properties, mammalian toxicity, environmental toxicity, environmental fate, including chemical and biotic degradation). This information may come from in vivo or in vitro test results, non-testing data such as QSAR estimates, existing data on human effects, read across from other substances, epidemiological data; • Information on manufacture and uses: current and foreseen; • Information on exposure: current and anticipated; • Information on Risk Management Measures (RMM): already implemented or proposed. This data gathering exercise is to be done irrespective of the volume. Indeed, if the data requirements at registration depend upon the volume manufactured or imported by each registrant, registrants must register all relevant and available data for a specific endpoint. Nevertheless, they have to share on request data available that correspond to a higher tonnage threshold. NB: In summary, Step 1 requires each potential registrant to assemble and document all the information on the substance, available in-house (regardless of the envisaged registration tonnage) - including information on the substance’s (1) intrinsic properties (irrespective of tonnage), (2) uses, exposure and risk management measures. Potential registrants are encouraged to start gathering all relevant and available information as soon as possible, even before the formation of the SIEF for that substance. 3.3.3.2 Step 2: Agreement on the form of cooperation/cost sharing mechanism Before potential registrants (and potentially other SIEF Participants) start exchanging information on the data they have available, it is recommended that they first agree on the form of cooperation that best suits them and the main rules applicable to that cooperation, in terms of data and cost sharing.
<strong>Guidance</strong> on data sharing Version 2.0 April 2012 49 NB: In summary, Step 2 requires potential registrants (and potentially data holders) to (virtually) meet, discuss and agree on the main elements of the gathering of information, identification of information needs, generation of missing information, and sharing of the costs related to all registration activities. 3.3.3.3 Step 3: Collection and Inventory creation of information available to potential registrants In step 3, potential registrants should first organize themselves to complete the data collection phase, by collecting all information they have available individually. If literature searches have not been done individually in Step 1, these must be done jointly at this stage in order to gather all available information. To the extent that available data is not sufficient for registration purposes (Step 6 below), potential registrants must collect data available from (1) data holders, (2) other SIEFs and (3) outside the SIEFs. However, if the potential registrants know in advance, for example from previous contacts, that they do not have a complete data set with their own data, they may decide to contact data holders or other SIEFs early. Information from other SIEFs can be obtained after requesting read–across from another substance. Collecting data available to potential registrants can be done in the form of a questionnaire structured according to Annexes VI to X of REACH which the lead registrant sends to all potential registrants and that is returned within the requested deadline. This questionnaire may also include a request to communicate the classification and labelling of the substance. In order to help participants review available data a form is proposed, as an example, in Annex 1. As the above data is being collected, it should be entered into a common inventory. This would best be in the form of a matrix which compares the data available for each end point (up to the highest tonnage threshold among potential registrants) with the data needs and identifies key elements for each study, including the identity of the data holder. To the extent that the literature search may require considerable time to be completed, it is recommended that potential registrants continue their work and initiate Steps 4 and possibly 5 below without waiting for Step 3 to be completed. NB: In summary, Step 3 requires potential registrants to collect and create an inventory of all information on the substance they have available within the SIEF. They may also consider at this stage data available to data holders, in other SIEFs and outside of the SIEFs, in particular in situations where potential registrants know they do not have a full data set for Registration purposes. 3.3.3.4 Step 4: Evaluation of available information within the SIEF The next step is for potential registrants to evaluate the data available on the substance to be registered. This step may be undertaken by the lead registrant, any other potential registrant, or a representative acting on behalf of all potential registrants. Essentially, for each endpoint, the following actions must be performed: • Assess the relevance, reliability, adequacy and fitness for purpose of all gathered data (for more details please consult the <strong>Guidance</strong> on information requirements for arriving at conclusions on the hazard assessment and for risk characterization).
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