ANNEX IIBU.K.COMMON CORE DATA SET FOR BIOCIDAL PRODUCTSCHEMICAL PRODUCTS
1.Dossiers on biocidal products 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.
3.Information may be derived from existing data where a justification acceptable to the competent authority is provided. In particular, the provisions of Directive 88/379/EEC should be used wherever possible to minimise animal testing.U.K.
Dossier requirementsU.K.
I.ApplicantU.K.
II.Identity of the biocidal productU.K.
III.Physical and chemical properties of the biocidal productU.K.
IV.Methods for identification and analysis of the biocidal productU.K.
V.Intended uses of the biocidal product and efficacy for these usesU.K.
VI.Toxicology data for the biocidal product (additional to that for the active substance)U.K.
VII.Ecotoxicology data for the biocidal product (additional to that for the active substance)U.K.
VIII.Measures necessary to protect man, animals and the environmentU.K.
IX.Classification, packaging and labellingU.K.
X.Summary and evaluation of Sections II to IXU.K.
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.Formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s))U.K.
II.IDENTITYU.K.
2.1.Trade name or proposed trade name, and manufacturer's development code number of the preparation, if appropriateU.K.
2.2.Detailed quantitative and qualitative information on the composition of the biocidal product, e.g. active substance(s), impurities, adjutants, inert componentsU.K.
2.3.Physical state and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solutionU.K.
III.PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIESU.K.
3.1.Appearance (physical state, colour)U.K.
3.2.Explosive propertiesU.K.
3.3.Oxidising propertiesU.K.
3.4.Flash-point and other indications of flammability or spontaneous ignitionU.K.
3.5.Acidity/alkalinity and if necessary pH value (1 % in water)U.K.
3.6.Relative densityU.K.
3.7.Storage stability — stability and shelf-life. Effects of light, temperature and humidity on technical characteristics of the biocidal product; reactivity towards container materialU.K.
3.8.Technical characteristics of the biocidal product, e.g. wettability, persistent foaming, flowability, pourability and dustabilityU.K.
3.9.Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorisedU.K.
IV.METHODS OF IDENTIFICATION AND ANALYSISU.K.
4.1.Analytical method for determining the concentration of the active substance(s) in the biocidal productU.K.
4.2.In so far as not covered by Annex IIA, paragraph 4.2, analytical methods including recovery rates and the limits of determination for toxicologically and ecotoxicologically relevant components of the biocidal product and/or residues thereof, where relevant in or on the following:U.K.
(c)
Water (including drinking water)
(d)
Animal and human body fluids and tissues
(e)
Treated food or feedingstuffs
V.INTENDED USES AND EFFICACYU.K.
5.1.Product type and field of use envisagedU.K.
5.2.Method of application including description of system usedU.K.
5.3.Application rate and if appropriate, the final concentration of the biocidal product and active substance in the system in which the preparation is to be used, e.g. cooling water, surface water, water used for heating purposesU.K.
5.4.Number and timing of applications, and where relevant, any particular information relating to geographical variations, climatic variations, or necessary waiting periods to protect man and animalsU.K.
5.5.Function, e.g. fungicide, rodenticide, insecticide, bactericideU.K.
5.6.Pest organism(s) to be controlled and products, organisms or objects to be protectedU.K.
5.7.Effects on target organismsU.K.
5.8.Mode of action (including time delay) in so far as not covered by Annex IIA, paragraph 5.4U.K.
5.9.User: industrial, professsional, general public (non-professional)U.K.
Efficacy data
5.10.The proposed label claims for the product and efficacy data to support these claims, including any available standard protocols used, laboratory tests, or field trials, where appropriateU.K.
5.11.Any other known limitations on efficacy including resistanceU.K.
VI.TOXICOLOGICAL STUDIESU.K.
6.1.Acute toxicityU.K.
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
6.1.1.OralU.K.
6.1.2.DermalU.K.
6.1.3.InhalationU.K.
6.1.4.For biocidal products that are intended to be authorised for use with other biocidal products, the mixture of products, where possible, shall be tested for acute dermal toxicity and skin and eye irritation, as appropriateU.K.
6.2.Skin and eye irritation (1)U.K.
6.3.Skin sensitisationU.K.
6.4.Information on dermal absorptionU.K.
6.5.Available toxicological data relating to toxicologically relevant non-active substances (i.e. substances of concern)U.K.
6.6.Information related to the exposure of the biocidal product to man and the operatorU.K.
Where necessary, the test(s) described in Annex IIA, shall be required for the toxicologically relevant non-active substances of the preparation
VII.ECOTOXICOLOGICAL STUDIESU.K.
7.1.Foreseeable routes of entry into the environment on the basis of the use envisagedU.K.
7.2.Information on the ecotoxicology of the active substance in the product, where this cannot be extrapolated from the information on the active substance itselfU.K.
7.3.Available ecotoxicological information relating to exotoxicological relevant non-active substances (i.e. substances of concern), such as information from safety data sheetsU.K.
VIII.MEASURES TO BE ADOPTED TO PROTECT MAN, ANIMALS AND THE ENVIRONMENTU.K.
8.1.Recommended methods and precautions concerning handling, use, storage, transport or fireU.K.
8.2.Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment; in so far as not covered by Annex IIA, paragraph 8.3U.K.
8.3.Procedures, if any, for cleaning application equipmentU.K.
8.4.Identity of relevant combustion products in cases of fireU.K.
8.5.Procedures for waste management of the biocidal product and its packaging for industry, professional users and the general public (non-professional users), e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incinerationU.K.
8.6.Possibility of destruction or decontamination following release in or on the following:U.K.
(b)
Water, including drinking water
8.7.Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organismsU.K.
8.8.Specify any repellents or poison control measures included in the preparation that are present to prevent action against non-target organismsU.K.
IX.CLASSIFICATION, PACKAGING AND LABELLINGU.K.
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
X.SUMMARY AND EVALUATION OF SECTIONS II TO IXU.K.
NotesU.K.
(1)Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.U.K.