- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (16/02/1998)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
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European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)
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Version Superseded: 01/09/2013
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Applicant
Identity of the biocidal product
Physical and chemical properties of the biocidal product
Methods for identification and analysis of the biocidal product
Intended uses of the biocidal product and efficacy for these uses
Toxicology data for the biocidal product (additional to that for the active substance)
Ecotoxicology data for the biocidal product (additional to that for the active substance)
Measures necessary to protect man, animals and the environment
Classification, packaging and labelling
Summary and evaluation of Sections II to IX
The following data will be required to support submission on the above points.
Soil
Air
Water (including drinking water)
Animal and human body fluids and tissues
Treated food or feedingstuffs
Efficacy data
For studies 6.1.1 to 6.1.3, biocidal products other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will depend on the nature of the product and the likely route of human exposure. Gases and volatile liquids should be administered by the inhalation route
Where necessary, the test(s) described in Annex IIA, shall be required for the toxicologically relevant non-active substances of the preparation
Air
Water, including drinking water
Soil
Proposals for packaging and labelling
Proposals for safety-data sheets, where appropriate
Justification for the classification and labelling according to the principles of Article 20 of this Directive
Hazard symbol(s)
Indications of danger
Risk phrases
Safety phrases
Packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging materials to be included
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