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Existing as biocides act_ordinance.docx

This document is a non certified translation and is meant purely as a documentation tool. The information in this document does not constitute legal advice. The only legally binding form of the translated ordinance is the official version, as published in the Federal Law Gazette, in German language. Short title
Biocides Act-Ordinance on Existing Active Substances Promulgation
Date of entry into force
Long title
Ordinance of the Federal Minister of Agriculture, Forestry, Environment and Water Management on time periods relating to the authorisation or registration of biocidal products containing active substances which have been included in accordance with Article 16 (2) of the Biodical Products Directive in Annex I or I A thereto, and relating to those existing active substances which may no longer be used within biocidal products that are placed on the market (Biocides Act-Ordinance on Existing Active Substances) Original version: Federal Legal Gazette II No. 353/2008 [CELEX-Nr.: 32006L0140, 32007L0020, 32007L0069, 32007L0070, 32008L0015, 32008L0016, 32008L0075, 32008L0077, 32008L0078, 32008L0079, 32008L0080, 32008L0081] Amendment
Federal Legal Gazette II No. 346/2009 [CELEX-Nr.: 32008L0085, 32008L0086, 32009L0084, 32009L0085, 32009L0086, 32009L0089, 32009L0091, 32009L0092, 32009L0093, 32009L0094, 32009L0095, 32009L0096, 32009L0098, 32009L0099] Federal Legal Gazette II No. 94/2011 [CELEX-Nr.: 32009L0150, 32009L0151, 32010L0007, 32010L0008, 32010L0009, 32010L0010, 32010L0011, 32010L0050, 32010L0051, 32010L0072, 32010L0074] Preamble/promulgation clause
By virtue of section 4 (2) of the Act on Biocidal Products – Biocides Act, Federal Legal Gazette I No. 105/2000, as amended by federal law, Federal Legal Gazette I No 151/2004, the following provisions have been enacted: List of active substances
Section 1. (1) Those active substances which are listed in the Annex to this Ordinance, which are intended
for use in biocidal products for the purpose of the Biocidal Products Act–Biocides Act, Federal Legal Gazette I No. 105/2000, shall be promulgated as active substances which have been included, in accordance with Article 16 (2) of Directive 98/8/EC concerning the placing of biocidal products on the market (as set out in section 2 (1) (1) of the Biocides Act: Biocidal Products Directive), OJ No. L 123 of 24.04.1998 p. 1, in Annex I or I A thereto. (2) The data set out in the Annex to this Ordinance concerning the requirements for the placing on the market and the authorisation or registration of biocidal products containing one of the active substances listed in the Annex shall be binding. The content and conclusions of assessment reports on individual active substances referred to in the relevant Directives of the European Commission relating to the inclusion of active substances in Annex I or I A of the Biocidal Products Directive shall be taken into account as authoritative information for the authorisation or registration procedures of the relevant biocidal products. (3) If an active substance has been included in the Annex to this Ordinance, biocidal products within the meaning of section 2 (1)( 2) of the Biocides Act which contain that active substance shall, in accordance with the provisions set forth below, be placed on the market only if they have been authorised or registered in accordance with Part 3 of the Biocides Act. Requirements for the placing on the market of biocidal products which are subject to authorisation
Section 2. (1) Within the meaning of section 4 (1) and (2) of the Biocides Act, the placing on the market of
biocidal products which are no low-risk biocidal products and which contain an active substance listed in the Annex to this Ordinance but no other existing active substance (section 2 (1)(16) of the Biocides Act) which is listed in Annex II of Regulation (EC) No. 1451/2007 on the second phase of the 10-year work programme in accordance with Article 16 (2) of Directive 98/8/EC concerning the placing of biocidal products on the market, OJ No. L 325 of 11.12.2007 p. 3, shall only be admissible, within the relevant active substance/product type combinations listed in the Annex to this Ordinance, if the respective biocidal product has been placed on the market in Austria before the date of inclusion of the respective active substance in Annex I of the Biocidal Products Directive and 1. an application for authorisation has been submitted for the respective active substance/product type combination, in accordance with section 11 (1) or section 15 of the Biocides Act, not later than the date specified in column 4 of the Annex to this Ordinance or 2. a written communication within the meaning of subsection (2) (2) A corresponding application (subsection (1)(1)) or a corresponding written communication (subsection (1)(2)) specifying that, not later than four months before the date stipulated in column 5 for the relevant active substance/product type combination, an application will be submitted in accordance with section 13 of the Biocides Act, whereupon the written communication shall be supported by data in accordance with section 13 (1)(1) and (4) of the Biocides Act as well as with Annex II B Section I and X and, where applicable, Annex IV B Section I and X of the Biocidal Products Directive, shall be a necessary requirement for the admissibility of the placing on the market of a biocidal product during an ongoing authorisation procedure. Such an application, or such a communication, can be submitted at the earliest three months before the date specified in column 4 of the Annex for the relevant active substance/product type combination. The effective submission date shall always be the date specified in column 4 for the relevant active substance/product type combination. (3) If neither an application in accordance with subsection (1)(1) is submitted to the authority, nor a communication as referred to in subsection (1)(2), the respective biocidal products may be placed or remain on the market for no longer than six months from the date specified in column 4 for the relevant active substance/product type combination. Stocks of the relevant biocidal products may be sold off for another six months, provided they have been in existence in Austria before the expiration of six months from the date specified in column 4 for the relevant active substance/product type combination. (4) Biocidal products subject to authorisation as described in subsection (1) and (2) may be placed on the market provisionally up to the date specified for the respective active substance/product type combination in column 5 of the Annex to this Ordinance, provided that an application or a communication as referred to in subsection (1) has been received within the specified period. In the case of a communication as referred to in subsection (1)(2) it shall also be required that a complete application in accordance with section 13 of the Biocides Act be submitted for the relevant biocidal product not later than four months before the date specified in column 5 of the Annex to this Ordinance for the relevant active substance/product type combination. Whether the further placing on the market of the biocidal product is admissible depends on the decisions reached in the course of the authorisation procedure. (5) If an application for authorisation is refused or rejected in the course of a procedure pursuant to section 11 (1) or section 13 of the Biocides Act, the respective biocidal product shall no longer be placed or remain on the market from the date on which such a decision becomes legally effective. Here section 17 (6) of the Biocides Act shall apply. First placing on the market of a biocidal product after inclusion of an active substance in Annex I of the
Biocidal Products Directive
Section 3. Biocidal products of an active substance/product type combination which are no low-risk biocidal products and which contain an active substance listed in the Annex to this Ordinance but no other existing active substance which is listed in the Annex II of Regulation (EC) No. 1451/2007, which have not been placed on the market in Austria before the date of inclusion of that active substance onto Annex I of the Biocidal Products Directive have to comply, from the date of inclusion of that active substance onto Annex I of the Biocidal Products Directive, with the requirement of section 4 (1)(1) of the Biocides Act and shall be subject to authorisation in accordance with sections 8, 10, 11, 13 and 15 pp. of the Biocides Act. Requirements for the placing on the market of biocidal products subject to registration
Section 4. (1) Within the meaning of section 4 (1) and (2) of the Biocides Act, the placing on the market of low-risk biocidal products which contain an active substance listed in the Annex to this Ordinance but no other existing active substance which is listed in Annex II of Regulation (EC) No. 1451/2007, within a substance/product type combination listed in the Annex to this Ordinance, shall only be admissible if the respective low-risk biocidal product has been placed on the market in Austria before the date of inclusion of the respective active substance onto Annex I A of the Biocidal Products Directive and 1. an application for registration of the respective active substance/product type combination has been submitted in accordance with section 11 (2) or section 15 of the Biocides Act not later than the date specified in column 4 of the Annex to this Ordinance or 2. a communication within the meaning of subsection (2) has been submitted. (2) A corresponding application (subsection (1)(1)) or a corresponding written communication (subsection (1)(2)) specifying that, not later than two months before the date indicated in column 5 for the respective active substance/product type combination, an application will be submitted in accordance with section 14 of the Biocides Act, whereupon the written communication shall be supported by data in accordance with section 14 (1)(1) and in accordance with section 9 (2)(1) to (3) as well as (6) and (7) of the Biocides Act, shall be a necessary requirement for the admissibility of the placing of a biocidal product on the market during an ongoing registration procedure. Such an application, or such a communication, can be submitted at the earliest three months before the date specified in column 4 of the Annex. The date specified in column 4 shall always be considered the effective submission date. (3) If neither an application in accordance with subsection (1)(1) is submitted to the authority, nor a communication as referred to in subsection (1)(2), the respective low-risk biocidal products may be placed or remain on the market for no longer than six months from the date specified in column 4 for the relevant active substance/product type combination. (4) Low-risk biocidal products which are subject to registration as described in subsection (1) and (2) may be placed on the market provisionally up to the date indicated in column 5 of the Annex to this Ordinance for the relevant active substance/product type combination, provided an application or a communication as referred to in subsection (1) has been received within the specified period. In the case of a communication as referred to in subsection (1)(2) it shall furthermore be required that a complete application in accordance with section 14 of the Biocides Act be submitted for the respective low-risk biocidal product not later than two months before the date specified in column 5 of the Annex to this Ordinance for the respective active substance/product type combination. Whether the further placing on the market of the biocidal product is admissible depends on the decision reached in the course of the registration procedure. (5) If an application for registration is refused or rejected in the course of a procedure in accordance with section 11 (2) or section 14 of the Biocides Act, the respective low-risk biodical product shall no longer be placed on the market from the date on which such a decision becomes legally effective. Here section 17 (6) of the Biocides Act shall apply. First placing on the market of a low-risk biocidal product
after inclusion of an active substance in Annex I A of the Biocidal Products Directive
Section 5. Biocidal products which pose a low risk within their respective active substance/product type combination and which contain an active substance listed in the Annex to this Ordinance but no other existing active substance which is listed in Annex II of Regulation (EC) No. 1451/2007, and which have not been placed on the market in Austria before the date of inclusion of the respective active substance onto Annex I A of the Biocidal Products Directive, have to comply with the requirement of section 4 (1)(2) of the Biocides Act from the date of inclusion of that active substance onto Annex I A of the Biocidal Products Directive and shall be subject to registration according to sections 9, 10, 11, 14 and 15 pp. of the Biocides Act. Biocidal products containing more than one active substance
Section 6. A biocidal product which contains, in addition to one of the active substances listed in the Annex of this Ordinance, at least one other active substance of the respective active substance/product type combination not listed therein but included in Annex II of Regulation (EC) No. 1451/2007, shall not be subject to authorisation or registration within the meaning of sections 2 and 4 until the date specified in column 4 of the Annex to this Ordinance for the active substance/product type combination with the last date of inclusion onto Annex I or I A of the Biocidal Products Directive has been reached. New biocidal products
Section 7. If a biocidal product contains, as active substances, only those which have been included in the Annex to this Ordinance and if that biocidal product has not been placed on the market in Austria by the date specified in column 4 for the active substance with the earliest date of inclusion onto Annex I or I A of the Biocidal Products Directive (new biocidal product), an authorisation or registration procedure in accordance with the 3rd Part of the Biocides Act shall be conducted without having to take into consideration the dates or time limits referred to in sections 2 or 4. Such a biocidal product may not be placed on the market until authorisation or registration has been granted. Existing active substances which may no longer be placed on the market
Section 8. (1) It is found and declared that active substances which are listed in Annex I of Regulation (EC)
No. 1451/2007 shall no longer be placed on the market, neither as such nor when contained in biocidal products. (2) It is found and declared that those existing active substances which have been notified pursuant to Regulation (EC) No. 1896/2000 on the first phase of the programme referred to in Article 16 (2) of the Biocidal Products Directive 98/8/EC, OJ No. L 228 of 08.09.2000 p. 6, as well as pursuant to Regulation (EC) No. 1687/2002 on an additional period for notification of certain active substances already on the market for use in biocidal products, OJ No. L 258 of 26.09.2002 p. 15, but not included in Annex I, I A or I B of the Biocidal Products Directive, and which are referred to in 1. Commission Decision concerning the non-inclusion of certain substances to be examined under the 10- year work programme according to Article 16 (2) of Directive 98/8/EC, OJ No. L 216 of 21.08.2007 p. 17, 2. Commission Decision concerning the non-inclusion of guazatine triacetate in Annex I, I A or I B of Directive 98/8/EC, OJ No. L 230 of 01.09.2007 p. 18, 3. Commission Decision concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2008/681/EC), OJ No. L 222 of 20.08.2008 p. 7, 4. Commission Decision concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2008/809/EC), OJ No. L 281 of 24.10.2008 p. 16, 5. Commission Decision concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2009/322/EC), OJ No L 95 of 09.04.2009 p. 44, 6. Commission Decision concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2009/324/EC), OJ No. L 96 of 15.04.2009 p. 37, 7. Commission Decision concerning the non-inclusion of diazinon in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2010/71/EU), OJ No. L 36 of 09.02.2010 p. 34, 8. Commission Decision concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2010/72/EU), OJ No. L 36 of 09.02.2010 p. 36 or 9. Commission Decision concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2010/675/EU), OJ No. L 291 of 09.11.2010 p. 47 may no longer be placed on the market, neither as such nor when contained in biocidal products belonging to substance/product type combinations referred to in the relevant decisions of the European Commission, after the expiration of one year from the date of entry into force of the relevant decision unless that decision provides another time limit for the placing on the market. If a decision sets specific time limits for the placing on the market for given substance/product type combinations, those time limits shall be applicable. Note on implementation
Section 9. The present Ordinance serves for the implementation of
1. Directive 2006/140/EC amending Directive 98/8/EC of the European Parliament and of the Council to include sulfuryl fluoride as an active substance in Annex I thereto, OJ No. L 414 of 30.12.2006 p. 78, 2. Directive 2007/20/EC amending Directive 98/8/EC of the European Parliament and of the Council to include dichlofluanid as an active substance in Annex I thereto, OJ No. L 94 of 4.4.2007 p. 23, 3. Directive 2007/69/EC 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include difethialone as an active substance in Annex I thereto, OJ No. L 312 of 30.11.2007 p. 23, 4. Directive 2007/70/EC amending Directive 98/8/EC of the European Parliament and of the Council to include carbon dioxide as an active substance in Annex I A thereto, OJ No. L 312 of 30.11.2007 p. 26, 5. Directive 2008/15/EC amending Directive 98/8/EC of the European Parliament and of the Council to include clothianidin as an active substance in Annex I thereto, OJ No. L 42 of 16.2.2008 p. 45, 6. Directive 2008/16/EC amending Directive 98/8/EC of the European Parliament and of the Council to include etofenprox as an active substance in Annex I thereto, OJ No. L 42 of 16.2.2008 p. 48, 7. Directive 2008/75/EC amending Directive 98/8/EC of the European Parliament and of the Council to include carbon dioxide as an active substance in Annex I thereto, OJ No. L 197 of 25.7.2008 p. 54, 8. Directive 2008/77/EC amending 98/8/EC of the European Parliament and of the Council to include thiamethoxam as an active substance in Annex I thereto, OJ No. L 198 of 26.7.2008 p. 41, 9. Directive 2008/78/EC amending Directive 98/8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I thereto, OJ No. L 198 of 26.7.2008 p. 44, 10. Directive 2008/79/EC amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto, OJ No. L 200 of 29.7.2008 p. 12, 11. Directive 2008/80/EC amending Directive 98/8/EC of the European Parliament and of the Council to include cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO) as an active substance in Annex I thereto, OJ No. L 200 of 29.7.2008 p. 15, 12. Directive 2008/81/EC amending Directive 98/8/EC of the European Parliament and of the Council to include difenacoum as an active substance in Annex I thereto, OJ No. L 201 of 30.7.2008 p. 46, 13. Directive 2008/85/EC amending Directive 98/8/EC of the European Parliament and of the Council to include thiabendazole in Annex I thereto, OJ No. L 239 of 06.09.2008 p. 6, 14. Directive 2008/86/EC amending Directive 98/8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto, OJ No. L 239 of 06.09.2008 p. 9, 15. Directive 2009/84/EC amending Directive 98/8/EC of the European Parliament and of the Council to include sulfuryl fluoride as an active substance in Annex I thereto, OJ No. L 197 of 29.07.2009 p. 67, 16. Directive 2009/85/EC amending Directive 98/8/EC of the European Parliament and of the Council to include coumatetralyl as an active substance in Annex I thereto, OJ No. L 198 of 30.07.2009 p. 28, 17. Directive 2009/86/EC amending Directive 98/8/EC of the European Parliament and of the Council to include fenpropimorph as an active substance in Annex I thereto, OJ No. L 198 of 30.07.2009 p. 31, 18. Directive 2009/89/EC amending Directive 98/8/EC of the European Parliament and of the Council to include nitrogen as an active substance in Annex I thereto, OJ No. L 199 of 31.07.2009 p. 19, 19. Directive 2009/91/EC amending Directive 98/8/EC of the European Parliament and of the Council to include disodium tetraborate as an active substance in Annex I thereto, OJ No. L 201 of 01.08.2009 p. 39, 20. Directive 2009/92/EC amending Directive 98/8/EC of the European Parliament and of the Council to include bromadiolone as an active substance in Annex I thereto, OJ No. L 201 of 01.08.2009 p. 43, 21. Directive 2009/93/EC amending Directive 98/8/EC of the European Parliament and of the Council to include alphachloralose as an active substance in Annex I thereto, OJ No. L 201 of 01.08.2009 p. 46, 22. Directive 2009/94/EC amending Directive 98/8/EC of the European Parliament and of the Council to include boric acid as an active substance in Annex I thereto, OJ No. L 201 of 01.08.2009 p. 50, 23. Directive 2009/95/EC amending Directive 98/8/EC of the European Parliament and of the Council to include aluminium phosphide releasing phosphine as an active substance in Annex I thereto, OJ No. L 201 of 01.08.2009 p. 54, 24. Directive 2009/96/EC amending Directive 98/8/EC of the European Parliament and of the Council to include disodium octaborate tetrahydrate as an active substance in Annex I thereto, OJ No. L 201 of 01.08.2009 p. 58, 25. Directive 2009/98/EC amending Directive 98/8/EC of the European Parliament and of the Council to include boric oxide as an active substance in Annex I thereto, OJ No. 203 of 05.08.2009 p. 58, 26. Directive 2009/99/EC amending Directive 98/8/EC of the European Parliament and of the Council to include chlorophacinone as an active substance in Annex I thereto, OJ No. 203 of 05.08.2009 p. 62, 27. Directive 2009/150/EC amending Directive 98/8/EC of the European Parliament and of the Council to include flocoumafen as an active substance in Annex I thereto, OJ No. L 313 of 28.11.2009 p. 75, 28. Directive 2009/151/EC amending Directive 98/8/EC of the European Parliament and of the Council to include tolylfluanid as an active substance in Annex I thereto, OJ No. L 313 of 28.11.2009 p. 78, 29. Directive 2010/7/EU amending Directive 98/8/EC of the European Parliament and of the Council to include magnesium phosphide releasing phosphine as an active substance in Annex I thereto, OJ No. L 37 of 10.02.2010 p. 33, 30. Directive 2010/8/EU amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin sodium as an active substance in Annex I thereto, OJ No. L 37 of 10.02.2010 p. 37, 31. Directive 2010/9/EU amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance aluminium phosphide releasing phosphine to product type 18 as defined in Annex V thereto, OJ No. L 37 of 10.02.2010 p. 40, 32. Directive 2010/10/EU amending Directive 98/8/EC of the European Parliament and of the Council to include brodifacoum as an active substance in Annex I thereto, OJ No. L 37 of 10.02.2010 p. 44, 33. Directive 2010/11/EU amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin as an active substance in Annex I thereto, OJ No. L 37 of 10.02.2010 p. 47, 34. Directive 2010/51/EU amending Directive 98/8/EC of the European Parliament and of the Council to include N,N-diethyl- meta-toluamide as an active substance in Annex I thereto, OJ No. L 211 of 12.08.2010 p. 14, 35. Directive 2010/50/EU amending Directive 98/8/EC of the European Parliament and of the Council to include dazomet as an active substance in Annex I thereto, OJ No. L 210 of 11.08.2010 p. 30, 36. Directive 2010/72/EU amending Directive 98/8/EC of the European Parliament and of the Council to include spinosad as an active substance in Annex I thereto, OJ No. L 288 of 05.11.2010 p. 20 and 37. Directive 2010/74/EU amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance carbon dioxide to product type 18, OJ No. L 292 of 10.11.2010 p. 36. ___________________________________________________________________________ Note: For the contents of the Annex consult the Annexes to the Commission Directives amending Directive 98/8/EC of the European Parliament and of the Council to include xxx as active substances in Annex I (or I A) thereto, accessible at

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