Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)
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Changes over time for: Division 3.
Llinell Amser Newidiadau
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
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Point in time view as at 31/12/2020.
Changes to legislation:
There are currently no known outstanding effects for the Regulation (EU) No 528/2012 of the European Parliament and of the Council, Division 3..
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3.PRODUCT-TAILORED EXPOSURE-DRIVEN TESTINGU.K.
3.1.Testing in accordance with some endpoints in Sections 8 and 9 of Annexes II and III, notwithstanding Article 6(2), may be omitted based on exposure considerations, where exposure data in accordance with Annex II or III are available.U.K.
In that case, the following conditions shall be met:
An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst case for all intended uses of the biocidal product that contains the active substance for which approval is applied, or of the biocidal product for which the authorisation is sought.
If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional data shall be submitted to assess whether the justification for data adaptation still applies.
The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly and transparently explained.
However, testing cannot be omitted for non-threshold effects. As a consequence, certain core data shall always be obligatory, e.g. genotoxicity testing.
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3.2.In all cases, adequate justification and documentation shall be provided. The justification shall be based on an exposure assessment, in accordance with the relevant Technical Notes for Guidance where available.U.K.
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