Biocides (Amendment No. 3) Regulations, 2013 (L.N. 347 of 2013)

B 4233 VERŻJONI ELETTRONIKA B 4233 L.N. 347 of 2013 PESTICIDES CONTROL ACT (CAP. 430) Biocides (Amendment No. 3) Regulations, 2013 IN exercise of the powers conferred by articles 4 and 5 of the Pesticides Control Act, the Minister for Sustainable Development, the Environment and Climate Change, in consultation with the Minister for Health, has made the following regulations: Citation, scope and commencement. S.L. 430.03 1. (1) The title of these regulations is the Biocides (Amendment No. 3) Regulations, 2013, and these regulations shall be read and construed as one with the Biocides Regulations, hereinafter referred to as "the principal regulations". (2) The scope of these regulations is to transpose Commission Directive 2013/41/EU of 18 July 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include 1R-trans phenothrin as an active substance in Annex I thereto. (3) These regulations shall come into force as from 1st September 2015. Amends Schedule I to the principal regulations. 2. Immediately after item 64 in Part A of Schedule I to the principal regulations, there shall be added the following new item: B 4234 VERŻJONI ELETTRONIKA B 4234 No Common Name IUPAC Name Identifica tion Numbers Minimum purity of the active substance in the biocidal product as placed on the market Date of inclusion Deadline for complian ce with Article 16(3) (except for products containin g more than one active sub stance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active subs tances) Expiry date of inclusion Prod uct type Specific provisions (*) "65 1R-trans pheno thrin 1R-trans pheno thrin IUPAC name: 3 phenoxy benzyl(1 R,3R) 2,2 dimethyl 3-(2 methyl prop-1 enyl) cyclopro panecar boxylate EC No: 247-431 2 CAS No: 26046 85-5 89% w/w of 1R trans pheno thrin 1 Septem ber 2015 31 August 2017 31 August 2025 18 The Union level risk assessment did not address all potential uses and exposure scenarios. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. Member States shall ensure that authorisations are subject to the following conditions: B 4235 VERŻJONI ELETTRONIKA B 4234 No Common Name IUPAC Name Identifica tion Numbers Minimum purity of the active substance in the biocidal product as placed on the market Date of inclusion Deadline for complian ce with Article 16(3) (except for products containin g more than one active sub stance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active subs tances) Expiry date of inclusion Prod uct type Specific provisions (*) "65 1R-trans pheno thrin 1R-trans pheno thrin IUPAC name: 3 phenoxy benzyl(1 R,3R) 2,2 dimethyl 3-(2 methyl prop-1 enyl) cyclopro panecar boxylate EC No: 247-431 2 CAS No: 26046 85-5 89% w/w of 1R trans pheno thrin 1 Septem ber 2015 31 August 2017 31 August 2025 18 The Union level risk assessment did not address all potential uses and exposure scenarios. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. Member States shall ensure that authorisations are subject to the following conditions: B 4235 Sum of all isomers: IUPAC name: (3 Phenoxy phenyl) methyl 2,2 dimethyl 3-(2 methyl prop-1 enyl) cyclopro pane-1 carboxy late EC No: 247 404-5 CAS No: 26002 80-2 95,5% w/w for the sum of all isomers (1) safe operational procedures shall be established for ultra low volume (ULV) application, and products shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means; (2) for products containing 1R-trans phenothrin that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded; (3) where appropriate, measures shall be taken to protect honey bees.". B 4236 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 €0.36