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European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)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Version Superseded: 01/09/2013
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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
ANNEX IIAU.K.COMMON CORE DATA SET FOR ACTIVE SUBSTANCESCHEMICAL SUBSTANCES
1.Dossiers on active substances are required to address at least all the points listed under ‘Dossier requirements’. Responses are required to be supported by data. The dossier requirements must be in line with technical development.U.K.
2.Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases a justification, acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation to which the applicant has the right of access.U.K.
Dossier requirementsU.K.
II.
Identity of the active substance
III.
Physical and chemical properties of the active substance
IV.
Methods of detection and identification
V.
Effectiveness against target organisms and intended uses
VI.
Toxicological profile for man and animals including metabolism
VII.
Ecotoxicological profile including environmental fate and behaviour
VIII.
Measures necessary to protect man, animals and the environment
IX.
Classification and labelling
X.
Summary and evaluation of Sections II to IX
The following data will be required to support submission on the above points.
I.APPLICANTU.K.
1.1.Name and address, etc.U.K.
1.2.Active substance manufacturer (name, address, location of plant)U.K.
II.IDENTITYU.K.
2.1.Common name proposed or accepted by ISO and synonymsU.K.
2.2.Chemical name (IUPAC nomenclature)U.K.
2.3.Manufacturer's development code number(s)U.K.
2.4.CAS and EC numbers (if available)U.K.
2.5.Molecular and structural formula (including full details of any isomeric composition), molecular massU.K.
2.6.Method of manufacture (syntheses pathway in brief terms) of active substanceU.K.
2.7.Specification of purity of the active substance in g/kg or g/1, as appropriateU.K.
2.8.Identity of impurities and additives (e.g. stabilisers), together with the structural formula and the possible range expressed as g/kg or g/1, as appropriateU.K.
2.9.The origin of the natural active substance or the precursor(s) of the active substance, e.g. an extract of a flowerU.K.
2.10.Exposure data in conformity with Annex VIIA to Directive 92/32/EEC().U.K.
III.PHYSICAL AND CHEMICAL PROPERTIESU.K.
3.1.Melting point, boiling point, relative density (1)U.K.
3.2.Vapour pressure (in Pa)(1)U.K.
3.3.Appearance (physical state, colour) (2)U.K.
3.4.Absorption spectra (UV/VIS, IR, NMR), and a mass spectrum, molar extinction at relevant wavelengths, where relevant (1)U.K.
3.5.Solubility in water including effect of pH (5 to 9) and temperature on solubility, where relevant (1)U.K.
3.6.Partition coefficient n-octanol/water including effect of pH (5 to 9) and temperature(1)U.K.
3.7.Thermal stability, identity of relevant breakdown productsU.K.
3.8.Flammability including auto-flammability and identity of combustion productsU.K.
3.9.Flash-pointU.K.
3.10.Surface tensionU.K.
3.11.Explosive propertiesU.K.
3.12.Oxidising propertiesU.K.
3.13.Reactivity towards container materialU.K.
IV.ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATIONU.K.
4.1.Analytical methods for the determination of pure active substance and, where appropriate, for relevant degradation products, isomers and impurities of the active substance and additives (e.g. stabilisers)U.K.
4.2.Analytical methods including recovery rates and the limits of determination for the active substance, and for residues thereof, and where relevant in/on the following:U.K.
(c)
Water: the applicant should confirm that the substance itself and any of its degradation products which fall within the definition of pesticides given for parameter 55 in Annex I to Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption() can be estimated with adequate reliability at the MAC specified in that Directive for individual pesticides
(d)
Animal and human body fluids and tissues
V.EFFECTIVENESS AGAINST TARGET ORGANISMS AND INTENDED USESU.K.
5.1.Function, e.g. fungicide, rodenticide, insecticide, bactericideU.K.
5.2.Organism(s) to be controlled and products, organisms or objects to be protectedU.K.
5.3.Effects on target organisms, and likely concentration at which the active substance will be usedU.K.
5.4.Mode of action (including time delay)U.K.
5.5.Field of use envisagedU.K.
5.6.User: industrial, professional, general public (non-professional)U.K.
5.7.Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategiesU.K.
5.8.Likely tonnage to be placed on the market per yearU.K.
VI.TOXICOLOGICAL AND METABOLIC STUDIESU.K.
6.1.Acute toxicityU.K.
For studies 6.1.1 to 6.1.3, substances 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 substance and the likely route of human exposure. Gases and volatile liquids should be administered by the inhalation route.
6.1.1.OralU.K.
6.1.2.DermalU.K.
6.1.3.InhalationU.K.
6.1.4.Skin and eye irritation (3)U.K.
6.1.5.Skin sensitisationU.K.
6.2.Metabolism studies in mammals. Basic toxicokinetics, including a dermal absorption studyU.K.
For the following studies, 6.3 (where necessary), 6.4, 6.5, 6.7 and 6.8, the required route of administration is the oral route unless it can be justified that an alternative route is more appropriate
6.3.Short-term repeated dose toxicity (28 days)U.K.
This study is not required when a sub-chronic toxicity study is available in a rodent
6.4.Subchronic toxicityU.K.
90-day study, two species, one rodent and one non-rodent
6.5.Chronic toxicity (4)U.K.
One rodent and one other mammalian species
6.6.Mutagenicity studiesU.K.
6.6.1. In-vitro gene mutation study in bacteriaU.K.
6.6.2. In-vitro cytogenicity study in mammalian cellsU.K.
6.6.3. In-vitro gene mutation assay in mammalian cellsU.K.
6.6.4.If positive in 6.6.1, 6.6.2 or 6.6.3, then an in-vivo mutagenicity study will be required (bone marrow assay for chromosomal damage or a micronucleus test)U.K.
6.6.5.If negative in 6.6.4 but positive in-vitro tests then undertake a second in-vivo study to examine whether mutagenicity or evidence of DNA damage can be demonstrated in tissue other than bone marrowU.K.
6.6.6.If positive in 6.6.4 then a test to assess possible germ cell effects may be requiredU.K.
6.7.Carcinogenicity study (4)U.K.
One rodent and one other mammalian species. These studies may be combined with those in 6.5
6.8.Reproductive toxicity (5)U.K.
6.8.1.Teratogenicity test — rabbit and one rodent speciesU.K.
6.8.2.Fertility study — at least two generations, one species, male and femaleU.K.
6.9.Medical data in anonymous formU.K.
6.9.1.Medical surveillance data on manufacturing plant personnel if availableU.K.
6.9.2.Direct observation, e.g. clinical cases, poisoning incidents if availableU.K.
6.9.3.Health records, both from industry and any other available sourcesU.K.
6.9.4.Epidemiological studies on the general population, if availableU.K.
6.9.5.Diagnosis of poisoning including specific signs of poisoning and clinical tests, if availableU.K.
6.9.6.Sensitisation/allergenicity observations, if availableU.K.
6.9.7.Specific treatment in case of an accident or poisoning: first aid measures, antidotes and medical treatment, if knownU.K.
6.9.8.Prognosis following poisoningU.K.
6.10.Summary of mammalian toxicology and conclusions, including no observed adverse effect level (NOAEL), no observed effect level (NOEL), overall evaluation with regard to all toxicological data and any other information concerning the active substances. Where possible any suggested worker protection measures should be included in summary formU.K.
VII.ECOTOXICOLOGICAL STUDIESU.K.
7.1.Acute toxicity to fishU.K.
7.2.Acute toxicity to Daphnia magna U.K.
7.3.Growth inhibition test on algaeU.K.
7.4.Inhibition to microbiological activityU.K.
7.5.BioconcentrationU.K.
Fate and behaviour in the environment
7.6.DegradationU.K.
7.6.1.BioticU.K.
7.6.1.1.Ready biodegradabilityU.K.
7.6.1.2.Inherent biodegradability, where appropriateU.K.
7.6.2.AbioticU.K.
7.6.2.1.Hydrolysis as a function of pH and identification of breakdown productsU.K.
7.6.2.2.Phototransformation in water including identity of the products of transformation (1)U.K.
7.7.Adsorption/desorption screening testU.K.
Where the results of this test indicate the need to do so, the test described in Annex IIIA Part XII.1 paragraph 1.2 shall be required, and/or the test described in Annex IIIA Part XII.2 paragraph 2.2
7.8.Summary of ecotoxicological effects and fate and behaviour in the environmentU.K.
VIII.MEASURES NECESSARY TO PROTECT MAN, ANIMALS AND THE ENVIRONMENTU.K.
8.1.Recommended methods and precautions concerning handling, use, storage, transport or fireU.K.
8.2.In case of fire, nature of reaction products, combustion gases, etc.U.K.
8.3.Emergency measures in case of an accidentU.K.
8.4.Possibility of destruction or decontamination following release in or on the following: (a) air (b) water, including drinking water (c) soilU.K.
8.5.Procedures for waste management of the active substance for industry or professional usersU.K.
8.5.1.Possibility of reuse or recyclingU.K.
8.5.2.Possibility of neutralisation of effectsU.K.
8.5.3.Conditions for controlled discharge including leachate qualities on disposalU.K.
8.5.4.Conditions for controlled incinerationU.K.
8.6.Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organismsU.K.
IX.CLASSIFICATION AND LABELLINGU.K.
Proposals including justification for the proposals for the classification and labelling of the active substance according to Directive 67/548/EEC
Hazard symbol(s)
Indications of danger
Risk phrases
Safety phrases
X.SUMMARY AND EVALUATION OF SECTIONS II TO IXU.K.
Notes U.K.
(1)These data must be submitted for the purified active substance of stated specification.U.K.
(2)These data must be submitted for the active substance of stated specification.U.K.
(3)Eye irritation test shall not be necessary where the active substance has been shown to have potential corrosive properties.U.K.
(4)The long-term toxicity and carcinogenicity of an active substance may not be required where a full justification demonstrates that these tests are not necessary.U.K.
(5)If, in exceptional circumstances, it is claimed that such testing is unnecessary, that claim must be fully justified.U.K.
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