Regulated Control Scheme Control of Specified Substances 14 December 2017
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1 Animal Products Notice Regulated Control Scheme Control of Specified Substances Issued under the Animal Products Act 1999
2 TITLE Animal Products Notice: Regulated Control Scheme Control of Specified Substances COMMENCEMENT This Animal Products Notice comes into force on 8 January REVOCATION This Animal Products Notice: Regulated Control Scheme revokes and replaces Animal Products (Control of Specified Substances) Notice ISSUING AUTHORITY This Animal Products Notice is issued pursuant to sections 38(2)(b) and 167(1)(f) of the Animal Products Act Dated at Wellington this 15 th day of December [signed] Allan Kinsella Director, Systems Audit, Assurance and Monitoring Ministry for Primary Industries (acting under delegated authority of the Director-General) Contact for further information Ministry for Primary Industries (MPI) Regulation & Assurance Branch Chemical and Microbiological Assurance PO Box 2526 Wellington residues@mpi.govt.nz Ministry for Primary Industries Page 1 of 10
3 Contents Page Introduction 3 Part 1: Preliminary Requirements Definitions 4 Part 2: General Obligations Administration of specified substances 5 Part 3: Obligations for Registrants Labelling of Agricultural Compounds and Veterinary Medicines 6 Part 4: Obligations for Distributors, Wholesalers and Retailers Labelling of Agricultural Compounds and Veterinary Medicines 7 Part 5: Obligations for Veterinarians and Other Users Administration of specified substances 8 Part 6: Exemptions General exemption Specific exemption 9 Schedule 1: Specified Substances 10 Ministry for Primary Industries Page 2 of 10
4 Introduction This introduction is not part of the Animal Products Notice, but is intended to indicate its general effect. Purpose The prime purpose of this Notice is establishing a regulated control scheme for the control of specified substances in food producing animals, which is necessary or desirable to meet overseas market access requirements that have been notified or made available under section 60 of the Act. Background This Notice imposes a regulated control scheme: a) for the control of specified substances in food producing animals; and b) that is required to meet OMARs notified and made available under section 60A of the Act. Who should read this Animal Products Notice? (1) This Notice applies to: a) registrants, distributors, wholesalers and retailers of agricultural compounds and veterinary medicines; and b) veterinarians and other persons able to use or administer agricultural compounds and veterinary medicines; and c) primary producers and primary processors. (2) The requirements of the Animal Products Notice: Regulated Control Scheme for Hormonal Growth Promotants, issued 20 July 2017 or any successor remain applicable to any specified substances which are authorised for use as hormonal growth promotants and which are exempt from any of the requirements of this Notice under clause 6.1(1). Why is this important? Any failure to operate in accordance with this Notice may result in animal material or animal products not being eligible for export with official assurances. For the purposes of section 135(1)(c) of the Animal Products Act 1999, a failure to comply with this Notice, without reasonable excuse, is an offence. Document History Version Date Section Changed Change(s) Description 25 July 2007 All Rewritten, new format and branding Ministry for Primary Industries Page 3 of 10
5 Part 1: Preliminary Requirements 1.1 Definitions (1) In this Notice, unless the context otherwise requires: Act means the Animal Products Act 1999; agricultural compounds has the meaning given in the Agricultural Compounds and Veterinary Medicines Act 1997; animal product has the meaning given in the Act, but excludes germplasm and live animals not exported as food; food-producing animal means an animal intended to be used in whole or part, including secretions, for human consumption; HGP Notice means the Animal Products Notice: Regulated Control Scheme for Hormonal Growth Promotants, issued 20 July 2017 or any successor; MPI means the Ministry for Primary Industries; registrants has the meaning given in the Agricultural Compounds and Veterinary Medicines Act 1997; specified substance means a substance listed in Schedule 1 to this Notice and includes any formulation or compound product containing that substance; and veterinary medicines has the meaning given in the Agricultural Compounds and Veterinary Medicines Act Ministry for Primary Industries Page 4 of 10
6 Part 2: General Obligations 2.1 Administration of specified substances (1) No person may administer a specified substance to the species of food-producing animals corresponding to the substances listed in Schedule 1. (2) No person may administer a specified substance to any food-producing animal unless that use is specifically permitted in the label instructions on or within the packaging of the product comprising of or containing the specified substance. (3) Food-producing animals administered with specified substances in breach of this Notice must not be used for the supply of food for human consumption. Ministry for Primary Industries Page 5 of 10
7 Part 3: Obligations for Registrants 3.1 Labelling of Agricultural Compounds and Veterinary Medicines (1) Labels of products comprising of or containing specified substances must clearly show that administration to food-producing animals of the species corresponding to the substances listed in Schedule 1 is prohibited. (2) In the case of proprietary products containing specified substances with non-complying labels, registrants must: a) apply amended labels to products under their control; and b) supply distributors, wholesalers and retailers with labels for attachment to packaging of products containing specified substances or recall the products from these businesses. Ministry for Primary Industries Page 6 of 10
8 Part 4: Obligations for Distributors, Wholesalers and Retailers 4.1 Labelling of Agricultural Compounds and Veterinary Medicines (1) Distributors, wholesalers and retailers must not supply specified substances to any person other than the manufacturer of the products comprising of or containing the specified substance or persons acting under the authority of the manufacturer until the labels required by clause 3.1 have been applied. Ministry for Primary Industries Page 7 of 10
9 Part 5: Obligations for Veterinarians and Other Users 5.1 Administration of specified substances (1) Veterinarians and other legal users of any specified substance or product containing a specified substance must administer the substance strictly in accordance with the conditions of registration of the product under the Agricultural Compounds and Veterinary Medicines Act Ministry for Primary Industries Page 8 of 10
10 Part 6: Exemptions 6.1 General exemption (1) Proprietary products containing specified substances and registered under the Agricultural Compounds and Veterinary Medicines Act 1997 solely as growth promotants for use in bovine animals and labelled accordingly are exempt from the requirements of clause 2.1(1) and 3.1(1). 6.2 Specific exemption (1) This sub-part applies to research institutes including research programmes undertaken at tertiary institutes. (2) The Director-General may exempt research institutes or programmes from the requirements to comply with Parts 2 and 5 of this Notice. (3) Applications for exemption in accordance with clause 6.2(2) must be made in writing by the person responsible for the research institute or programme. (4) The application must describe the controls to be applied by the research institute or under the programme to ensure that no animal treated with a specified substance will leave its place of residency, be on-sold or submitted for slaughter other than in accordance with the terms described in these controls. (5) Any exemption granted under this Part may include any conditions deemed necessary by the Director- General to ensure compliance with the provisions of this Notice or any other requirement under the Act. Ministry for Primary Industries Page 9 of 10
11 Schedule 1: Specified Substances Specified substance Oestradiol 17ß and its ester-like derivatives Prohibited species Bovine, ovine, caprine, cervine, equine and ratite Ministry for Primary Industries Page 10 of 10
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