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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)
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CHAPTER III RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE
CHAPTER IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS
CHAPTER VIII UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS
CHAPTER IX CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS
CHAPTER XV INFORMATION AND COMMUNICATION
Article 86. Active substances included in Annex I to Directive 98/8/EC
Article 90.Transitional measures concerning active substances evaluated under Directive 98/8/EC
Article 91.Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
Article 92.Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
Article 93. Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
Article 94. Transitional measures concerning treated articles
Article 95. Transitional measures concerning access to the active substance dossier
INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
1. This Annex sets out the information requirements for the preparation...
3. A detailed and full description of the studies conducted or...
6. Tests performed should comply with the relevant requirements of protection...
7. Where testing is done, a detailed description (specification) of the...
8. Where test data exist that have been generated before 1...
9. New tests involving vertebrates shall be conducted as the last...
INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
1. This Annex sets out the information requirements that shall be...
3. A detailed and full description of studies conducted and of...
4. The formats made available by the Agency shall be used...
5. Tests submitted for the purpose of authorisation shall be conducted...
6. Tests performed should comply with the relevant requirements of protection...
7. Where testing is done, a detailed quantitative and qualitative description...
8. Where test data exist that have been generated before 17...
9. New tests involving vertebrates shall be conducted as the last...
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
1. This Annex sets out the common principles for the evaluation...
4. A risk assessment on the active substance(s) present in the...
5. Additional risk assessments shall be carried out, in the same...
7. The results of the risk assessments carried out on the...
8. When making evaluations of a biocidal product the evaluating body...
9. The application of these common principles shall, when taken together...
10. In the case of biocidal products containing active substances covered...
11. During the process of evaluation, applicants and the evaluating bodies...
12. The judgments made by the evaluating body during the evaluation...
13. The data submitted in support of an application for authorisation...
14. A risk assessment on the active substance present in the...
15. In carrying out the assessment, the possibility of cumulative or...
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 information provided on the biocidal product family shall permit...
21. Where relevant the technical equivalence for every active substance contained...
Effects on human and animal health
22. The risk assessment shall take account of the following potential...
23. The effects previously mentioned result from the properties of the...
25. The hazard identification shall address the properties and potential adverse...
27. For repeated dose toxicity and reproductive toxicity the dose-response relationship...
28. For acute toxicity, corrosivity and irritation, it is not usually...
29. For mutagenicity and carcinogenicity, a non-threshold assessment should be carried...
30. With respect to skin sensitisation and respiratory sensitisation, in so...
31. When carrying out the risk assessment special consideration shall be...
32. An exposure assessment shall be carried out for each of...
33. The exposure assessment shall be based on the information in...
34. When conducting the exposure assessment, special consideration shall be given...
37. The risk assessment shall take account of any adverse effects...
38. The hazard identification shall address the properties and potential adverse...
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 the qualitative estimation of exposure, shall be...
45. When conducting the exposure assessment, special consideration shall be given...
46. For any given environmental compartment, the risk characterisation shall, as...
48. The evaluating body shall conclude that the biocidal product does...
Effects on human and animal health
59. The evaluating body shall consider possible effects on all human...
60. The evaluating body shall examine the relationship between exposure and...
61. Typically, the margin of exposure (MOEref) — the ratio between...
62. The evaluating body shall, where appropriate, conclude that criterion (iii)...
63. If, for non-professional users, the wearing of personal protective equipment...
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