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Directive 98/8/EC of the European Parliament and of the Council (repealed)Dangos y teitl llawn

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)

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XI.FURTHER HUMAN HEALTH-RELATED STUDIES

1.Food and feedingstuffs studies

1.1.Identification of degradation and reaction products and of metabolites of the active substance in treated or contaminated foods or feedstuffs

1.2.Behaviour of the residue of the active substance, its degradation products and, where relevant, its metabolites on the treated or contaminated food or feedstuffs including the kinetics of disappearance

1.3.Overall material balance for the active substance. Sufficient residue data from supervised trials to demonstrate that residues likely to arise from the proposed use would not be of concern for human or animal health

1.4.Estimation of potential or actual exposure of the active substance to humans through diet and other means

1.5.If residues of the active substance remain on feedingstuffs for a significant period of time then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin

1.6.Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the active substance

1.7.Proposed acceptable residues and the justification of their acceptability

1.8.Any other available information that is relevant

1.9.Summary and evaluation of data submitted under 1.1 to 1.8

2.Other test(s) related to the exposure to humans

Suitable test(s) and a reasoned case will be required

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