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- Point in Time (11/10/2011)
- Original (As adopted by EU)
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European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)
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Article 3.Authorisation for placing on the market of biocidal products
Article 10.Inclusion of an active substance in Annexes I, IA or IB
Article 11.Procedure for inclusion of an active substance in Annex I, IA or IB
Article 12.Use of data held by competent authorities for other applicants
Article 13.Cooperation in the use of data for second and subsequent applications for authorisation
Article 20.Classification, packaging and labelling of biocidal products
Article 35.This Directive shall enter into force on the 20th day...
Article 36.This Directive is addressed to the Member States.
LIST OF BASIC SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL
COMMON CORE DATA SET FOR ACTIVE SUBSTANCES
1. Dossiers on active substances are required to address at least...
2. Information which is not necessary owing to the nature of...
III. Physical and chemical properties of the active substance
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
2.5. Molecular and structural formula (including full details of any isomeric...
2.6. Method of manufacture (syntheses pathway in brief terms) of active...
2.7. Specification of purity of the active substance in g/kg or...
2.8. Identity of impurities and additives (e.g. stabilisers), together with the...
2.9. The origin of the natural active substance or the precursor(s)...
2.10. Exposure data in conformity with Annex VIIA to Directive 92/32/EEC....
V. EFFECTIVENESS AGAINST TARGET ORGANISMS AND INTENDED USES
5.1. Function, e.g. fungicide, rodenticide, insecticide, bactericide
5.2. Organism(s) to be controlled and products, organisms or objects to...
5.3. Effects on target organisms, and likely concentration at which the...
5.6. User: industrial, professional, general public (non-professional)
5.7. Information on the occurrence or possible occurrence of the development...
VI. TOXICOLOGICAL AND METABOLIC STUDIES
6.2. Metabolism studies in mammals. Basic toxicokinetics, including a dermal absorption...
6.4. Subchronic toxicity 90-day study, two species, one rodent and one...
6.9. Medical data in anonymous form
6.9.1. Medical surveillance data on manufacturing plant personnel if available
6.9.2. Direct observation, e.g. clinical cases, poisoning incidents if available
6.9.3. Health records, both from industry and any other available sources...
6.9.4. Epidemiological studies on the general population, if available
6.9.5. Diagnosis of poisoning including specific signs of poisoning and clinical...
6.9.6. Sensitisation/allergenicity observations, if available
6.9.7. Specific treatment in case of an accident or poisoning: first...
6.10. Summary of mammalian toxicology and conclusions, including no observed adverse...
VIII. MEASURES NECESSARY TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT
8.1. Recommended methods and precautions concerning handling, use, storage, transport or...
8.2. In case of fire, nature of reaction products, combustion gases,...
8.4. Possibility of destruction or decontamination following release in or on...
8.5. Procedures for waste management of the active substance for industry...
8.6. Observations on undesirable or unintended side-effects, e.g. on beneficial and...
(1) These data must be submitted for the purified active substance...
(2) These data must be submitted for the active substance of...
(3) Eye irritation test shall not be necessary where the active...
(4) The long-term toxicity and carcinogenicity of an active substance may...
(5) If, in exceptional circumstances, it is claimed that such testing...
COMMON CORE DATA SET FOR BIOCIDAL PRODUCTS
1. Dossiers on biocidal products are required to address at least...
2. Information which is not necessary owing to the nature of...
3. Information may be derived from existing data where a justification...
III. Physical and chemical properties of the biocidal product
IV. Methods for identification and analysis of the biocidal product
V. Intended uses of the biocidal product and efficacy for these...
VI. Toxicology data for the biocidal product (additional to that for...
VII. Ecotoxicology data for the biocidal product (additional to that for...
VIII. Measures necessary to protect man, animals and the environment
III. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
3.4. Flash-point and other indications of flammability or spontaneous ignition
3.5. Acidity/alkalinity and if necessary pH value (1 % in water)...
3.7. Storage stability — stability and shelf-life. Effects of light, temperature...
3.8. Technical characteristics of the biocidal product, e.g. wettability, persistent foaming,...
3.9. Physical and chemical compatibility with other products including other biocidal...
5.2. Method of application including description of system used
5.3. Application rate and if appropriate, the final concentration of the...
5.4. Number and timing of applications, and where relevant, any particular...
5.5. Function, e.g. fungicide, rodenticide, insecticide, bactericide
5.6. Pest organism(s) to be controlled and products, organisms or objects...
5.9. User: industrial, professsional, general public (non-professional)
5.10. The proposed label claims for the product and efficacy data...
5.11. Any other known limitations on efficacy including resistance
VIII. MEASURES TO BE ADOPTED TO PROTECT MAN, ANIMALS AND THE...
8.1. Recommended methods and precautions concerning handling, use, storage, transport or...
8.2. Specific treatment in case of an accident, e.g. first-aid measures,...
8.4. Identity of relevant combustion products in cases of fire
8.5. Procedures for waste management of the biocidal product and its...
8.6. Possibility of destruction or decontamination following release in or on...
8.7. Observations on undesirable or unintended side-effects, e.g. on beneficial and...
8.8. Specify any repellents or poison control measures included in the...
ADDITIONAL DATA SET FOR ACTIVE SUBSTANCES
1. Dossiers on active substances are required to address at least...
2. Information which is not necessary owing to the nature of...
1. Acute toxicity test on one other, non-aquatic, non-target organism
2. If the results of the ecotoxicological studies and the intended...
4. Any other biodegradability tests that are relevant from the results...
5. Phototransformation in air (estimation method), including identification of breakdown products...
6. If the results from paragraphs 7.6.1.2 in Annex IIA or...
VIII. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
XI. FURTHER HUMAN HEALTH-RELATED STUDIES
1. Food and feedingstuffs studies
1.1. Identification of degradation and reaction products and of metabolites of...
1.2. Behaviour of the residue of the active substance, its degradation...
1.3. Overall material balance for the active substance. Sufficient residue data...
1.4. Estimation of potential or actual exposure of the active substance...
1.5. If residues of the active substance remain on feedingstuffs for...
1.6. Effects of industrial processing and/or domestic preparation on the nature...
1.7. Proposed acceptable residues and the justification of their acceptability
1.9. Summary and evaluation of data submitted under 1.1 to 1.8...
XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT
XIII. FURTHER ECOTOXICOLOGICAL STUDIES
ADDITIONAL DATA SET FOR BIOCIDAL PRODUCTS
1. Dossiers on biocidal products are required to address at least...
2. Information which is not necessary owing to the nature of...
3. Information may be derived from existing data where a justification...
XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT
DATA SET FOR ACTIVE SUBSTANCES
1. For the purposes of this Annex, the term micro-organisms shall...
2. Where information is not necessary owing to the nature of...
3. A dossier within the meaning of Article 11(1) shall be...
4. Where the micro-organism has been genetically modified within the meaning...
I. IDENTITY OF THE MICRO-ORGANISM
1.3. Name and species description, strain characterisation
1.3.1. Common name of the micro-organism (including alternative and superseded names)...
1.3.2. Taxonomic name and strain indicating whether it is a stock...
1.3.3. Collection and culture reference number where the culture is deposited...
1.3.4. Methods, procedures and criteria used to establish the presence and...
1.4. Specification of the material used for manufacturing of formulated products...
III. FURTHER INFORMATION ON THE MICRO-ORGANISM
3.3. Product type(s) and category of users for which the micro-organism...
3.5. Information on the occurrence or possible occurrence of the development...
3.6. Methods to prevent loss of virulence of seed stock of...
3.7. Recommended methods and precautions concerning handling, storage, transport or fire...
3.11. Monitoring plan to be used for the active micro-organism including...
X. SUMMARY AND EVALUATION OF SECTIONS I TO IX INCLUDING CONCLUSIONS...
DATA SET FOR BIOCIDAL PRODUCTS
1. For the purposes of this Annex, the term micro-organisms shall...
2. Where, information is not necessary owing to the nature of...
3. Information may be derived from existing data where a justification...
4. Where testing is done, a detailed description (specification) of the...
II. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
2.4. Flash point and other indications of flammability or spontaneous ignition...
2.8. Physical, chemical and biological compatibility with other products including biocidal...
2.9. Summary and evaluation of physical, chemical and technical properties of...
3.5. Content of micro-organism in material used (e.g. in the application...
3.7. Number and timing of applications and duration of protection
3.8. Necessary waiting periods or other precautions to avoid adverse effects...
3.11. Information on the possible occurrence of the development of resistance...
3.12. Effects on the materials or products treated with the biocidal...
IV. FURTHER INFORMATION ON THE BIOCIDAL PRODUCT
4.1. Packaging and compatibility of the biocidal product with proposed packaging...
4.3. Re-entry periods, necessary waiting periods or other precautions to protect...
4.4. Recommended methods and precautions concerning: handling, storage, transport or fire...
4.6. Procedures for destruction or decontamination of the biocidal product and...
4.7. Monitoring plan to be used for the active micro-organism and...
XI. CLASSIFICATION, PACKAGING AND LABELLING OF THE BIOCIDAL PRODUCT
XII. SUMMARY AND EVALUATION OF SECTIONS I TO XI INCLUDING CONCLUSIONS...
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)(a) OF THIS DIRECTIVE
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
1. This Annex lays down principles to ensure that evaluations made...
3. A risk assessment on the active substance or substances present...
4. Additional risk assessments shall be carried out, in the same...
7. When making evaluations and taking decisions concerning the authorisation of...
8. The Member State shall comply with the requirements of mutual...
9. It is known that many biocidal products present only minor...
10. It is known that certain biocidal products are considered as...
11. The application of these common principles shall lead to the...
12. During the process of evaluation and decision-making, Member States and...
13. The judgments made by the Member State during the evaluation...
14. The data submitted in support of an application for authorisation...
15. A risk assessment on the active substance present in the...
16. For each active substance and each substance of concern present...
17. The results arrived at from a comparison of the exposure...
19. In certain cases it may be concluded that further data...
20. The risk assessment shall take account of the following potential...
21. The effects previously mentioned result from the properties of the...
23. The hazard identification shall address the properties and potential adverse...
24. In those cases where the test appropriate to hazard identification...
25. The Member State shall apply paragraphs 26 to 29 when...
26. For repeated dose toxicity and reproductive toxicity the dose response...
27. For acute toxicity, corrosivity and irritation, it is not usually...
28. For mutagenicity and carcinogenicity it shall be sufficient to determine...
29. With respect to skin sensitisation and respiratory sensitisation, in so...
30. Where toxicity data derived from observations of human exposure, e.g....
31. An exposure assessment shall be carried out for each of...
32. The exposure assessment shall be based on the information in...
33. Where adequately measured, representative exposure data are available, special consideration...
36. The risk assessment shall take account of any adverse effects...
37. The hazard identification shall address the properties and potential adverse...
38. In those cases where the test appropriate to hazard identification...
39. A dose (concentration) — response (effect) assessment shall be carried...
40. The PNEC shall be determined from the data on effects...
41. An assessment factor is an expression of the degree of...
42. For each environmental compartment an exposure assessment shall be carried...
43. A PEC, or where necessary a qualitative estimate of exposure,...
44. The PEC, or qualitative estimation of exposure, shall be determined...
45. Where adequately measured, representative exposure data are available, special consideration...
46. For any given environmental compartment, the risk characterisation shall, as...
55. Subject to paragraph 96, the Member State shall come to...
56. In making a decision concerning authorisation, the Member State shall...
58. The Member State shall comply with the principles of mutual...
59. The Member State shall apply the rules concerning the concept...
60. The Member State shall apply the rules concerning the concept...
61. The Member State shall only grant authorisation to those biocidal...
62. The Member State shall impose, where appropriate, conditions or restrictions...
63. In the decision-making process the Member State shall take into...
64. The Member State shall, when taking a decision concerning the...
65. The Member State shall prescribe that biocidal products shall be...
66. The Member State shall take the necessary measures to ensure...
67. The Member State shall take the necessary measures to ensure...
68. The Member State shall not authorise a biocidal product if...
69. The Member State shall consider possible effects on all human...
70. The Member State shall examine the relationship between the exposure...
71. The Member State shall, where possible, compare the results obtained...
72. The Member State shall, if appropriate, impose, as a condition...
73. If for non-professional users the wearing of personal protective equipment...
74. If the relationship between the exposure and the effect cannot...
75. No biocidal product classified according to Article 20(1) of this...
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