Biocides (Amendment) Regulations, 2009 (L.N. 16 of 2009)

B 41VERŻJONI ELETTRONIKA A.L. 16 ta’ l-2009 ATT DWAR IL-KONTROLL TAL-PESTIĊIDI (KAP. 430) Regolamenti ta’ l-2009 li jemendaw ir-Regolamenti dwar il-Bijoċidi BIS-SAĦĦA tas-setgħat mogħtija bl-artikoli 4 u 5 ta’ l-Att dwar il-Kontroll tal-Pestiċidi, il-Ministru għar-Riżorsi u Affarijiet Rurali, wara li kkonsulta lill-Prim Ministru u lill-Ministru għall Politika Soċjali, għamel dawn ir-regolamenti li ġejjin: 1. (1) It-titolu ta’ dawn ir-regolamenti hu Regolamenti ta’ l-2009 li jemendaw ir-Regolamenti dwar il-Bijoċidi, u għandhom jinqraw u jiftiehmu bħala ħaġa waħda mar-Regolamenti ta’ l-2004 dwar il-Bijoċidi, hawn iżjed ’il quddiem imsejħin “ir-regolamenti prinċipali”. (2) L-iskop ta’ dawn ir-regolamenti hu li jitrassponu d-Direttiva tal-Kummissjoni 2007/47/KE tal-Parlament Ewropew u tal-Kunsill tal-5 ta’ Settembru 2007 li temenda d-Direttiva tal Kunsill 90/385/KEE fuq approssimazzjoni tal-liġijiet tal-Istati Membri rigward il-mezzi mediċi attivi li jiddaħħlu f’xi parti tal ġisem, d-Direttiva tal-Kunsill 93/42/KEE dwar mezzi mediċi u d-Direttiva 98/8/KE dwar it-tqegħid fis-suq talprodotti bijoċidali, Direttiva tal-Kummissjoni 2008/15/KE tal-15 ta’ Frar, 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi l-clothianidin bħala sustanza attiva fl-Anness I għaliha, Direttiva tal-Kummissjoni 2008/16/KE tal-15 ta’ Frar 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi letofenprox bħala sustanza attiva fl-Anness I tagħha, Direttiva tal-Kummissjoni 2008/75/KE ta’ l-24 ta’ Lulju 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi d-dijossidu tal-karbonju bħala sustanza attiva fl Anness I tagħha, Direttiva tal-Kummissjoni 2008/77/KE tal-25 ta’ Lulju 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi tthiamethoxam bħala sustanza attiva fl Anness I għaliha, Direttiva tal-Kummissjoni 2008/78/KE tal-25 ta’ Lulju 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi lpropiconazole bħala sustanza attiva fl Titolu u skop. A.L. 294 ta’ l-2004. Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,364, 13 ta’ Jannar, 2009 Taqsima B B 42 VERŻJONI ELETTRONIKA Anness I tagħha, Direttiva tal-Kummissjoni 2008/79/KE tat-28 ta’ Lulju 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi l-IPBC bħala sustanza attiva fl-Anness I għaliha, Direttiva tal-Kummissjoni 2008/80/KE tat-28 ta’ Lulju 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi l-melħ tal-potassju tascyclohexylhydroxydiazene 1-oxide (K-HDO) bħala sustanza attiva fl-Anness I għaliha, Direttiva tal-Kummissjoni 2008/81/KE tad-29 ta’ Lulju 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi d-difenacoum bħala sustanza attiva fl-Anness I tagħha, Direttiva tal-Kummissjoni 2008/85/KE tal-5 ta’ Settembru 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi t-thiabendazole bħala sustanza attiva fl-Anness I għaliha u Direttiva tal-Kummissjoni 2008/86/KE tal-5 ta’ Settembru 2008 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal Kunsill biex tinkludi t-tebuconazole bħala sustanza attiva fl-Anness I tagħha. 2. Fir-regolament 2(2) tar-regolamenti prinċipali, minnufih wara l-partita (r) għandha tiżdied l-partita ġdida li ġejja: “(s) disposizzjonijiet dwar il-mezzi mediċi dijanjostiċi in vitro. ”. 3. Fi Skeda III li tinsab mar-regolamenti prinċipali, minnufih wara l-partita 3 għandhom jiżdiedu dawn il-partiti ġodda li ġejjin: Jemenda r-regolament 2 tar-regolamenti prinċipali. Jemenda Skeda III li tinsab mar regolamenti prinċipali. B 43VERŻJONI ELETTRONIKA No Common Name Inclusion Directive Date of implementation (*) "4 Clothianidin Commission Directive !February 2010 2008/15/EC 5 Etofenprox Commission Directive 1 February 2010 2008/16/EC 6 Tebuconazole Commission Directive 1 April 2010 2008/86/EC 7 Carbon Dioxide Commission Directive l November 2009 2008/75/EC 8 Propiconazole Commission Directive I April 2010 2008/78/EC 9 Difenacourn Commission Directive 1 April 2010 2008/8 1/EC 10 K-HDO Commission Directive I July2010 2008/80/EC I 1 IPBC Commission Directive I July 2010 2008/79/EC 13 Thiabendazole Commission Directive 1 July 2010 2008/85/EC 14 Thiamethoxam Commission Directive I July2010.". 2008/77/EC B 44 VERŻJONI ELETTRONIKA L.N. 16 of 2009 PESTICIDES CONTROL ACT (CAP. 430) Biocides (Amendment) Regulations, 2009 IN exercise of the powers conferred by articles 4 and 5 of the Pesticides Control Act, the Minister for Resources and Rural Affairs, in consultation with the Prime Minister and with the Minister for Social Policy, has made the following regulations: 1. (1) The title of these regulations is the Biocides (Amendment) Regulations, 2009 and they shall be read and construed as one with Biocides Regulations, 2004, hereinafter referred to as “the principal regulations”. (2) The scope of these regulations is to transpose Commission Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/ EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market, Commission Directive 2008/15/EC of 15 February 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include clothianidin as an active substance in Annex IA thereto, Commission Directive 2008/16/EC of 15 February 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include etofenprox as an active substance in Annex I thereto, Commission Directive 2008/75/EC of 24 July 2008 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, Commission Directive 2008/77/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include thiamethoxam as an active substance in Annex I thereto, Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I thereto, Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto, Commission Directive 2008/80/ EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO), Commission Directive 2008/81/ Title and scope. L.N. 294 of 2004. B 45VERŻJONI ELETTRONIKA EC of 29 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include difenacoum as an active substance in Annex I thereto, Commission Directive 2008/85/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include thiabendazole as an active substance in Annex I thereto, and Commission Directive 2008/86/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto. 2. (1) In regulation 2(2) of the principal regulations, immediately after item (r) thereof, there shall be added the following: “(s) provisions concerning in vitro diagnostic medical devices.” 3. In Schedule III to the principal regulations, immediately after item 3 thereof, there shall be added the following new items: Amends regulation 2 of the principal regulations. Amends Schedule III to the principal regulations. B 46 VERŻJONI ELETTRONIKA Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper Prezz/Price €0.28 No Common Name Inclusion Directive Date of implementation (*) "4 Clothianidin Commission Directive 1 February 2010 2008/15/EC 5 Etofenprox Commission Directive I February 20 I 0 2008/16/EC 6 Tebuconazole Commission Directive I April 2010 2008/86/EC 7 Carbon Dioxide Commission Directive l November 2009 2008/75/EC 8 Propiconazole Commission Directive I April 20 10 2008/78/EC 9 Difenacoum Commission Directive I April 2010 2008/81/EC 10 K-HDO Commission Directive I July 2010 2008/80/EC 11 IPBC Commission Directive I July 2010 2008/79/EC 13 Thiabendazole Commission Directive 1 July2010 2008/85/EC 14 Thiamethoxam Commission Directive 1 July 201 O.". 2008/77/EC 0