This content is current only at the time of printing. This document was printed on 11 December 2019. A current copy is located at https://apvma.gov.au/node/32816
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Regulatory Update #277
CEO addresses the European Parliament's Special Committee
Our CEO, Dr Chris Parker, recently shared the Australian perspective on the regulation of plant protection products with the European Parliament's Special Committee on the EU's Authorisation Procedure for Pesticides.
Dr Parker told the Committee members about how Australia sets standards, which helps industry access innovative agvet products. The question and answer session provided a comparative analysis for the Committee between Australia and other OECD countries, including Canada and the USA.
"It was a great opportunity to discuss the harmonisation of agvet chemical regulation," Dr Parker said.
Reminder: Annual return of active constituents
Less than one month remains for you to report your active constituent data for the 2017–18 financial year.
All holders of approvals and registrations must report the amount of active imported, manufactured or exported each financial year and retain records of this information for six years.
Reports for 2017–18 financial year must be submitted by 30 September 2018.
Provide feedback on our proposed regulatory decisions on Methiocarb
On 27 August 2018 we published the Methiocarb Proposed regulatory decisions report. The report is now open for consultation for a period of three months.
Methiocarb is currently registered for use in the control of snails, slugs, false wireworm beetles, millipedes and slaters in a range of agricultural and home garden situations. After consideration of all data and assessments, we have concluded that methiocarb active approvals and product registrations can continue provided the product labels are varied to delete, add or amend certain use patterns, amend safety directions and first aid instructions, add restraint statements and amend withholding periods. The details of these amendments are outlined in the report.
Voluntary product recalls
Manufacturers have issued voluntary recalls for the following products:
- Virbac Australia commenced a voluntary recall of Oralject Clair Gel Oral Bronchodilating Agent For Horses, APVMA Approval No: 38803, Pack size: 230 mL.
Virbac Australia advise there are no trade or safety issues and people who have the products listed should direct any questions to Virbac Australia.
- Elanco Australasia commenced a voluntary recall of Purina Total Care Flea Knockdown For Cats, Puppies and Small Dogs and Purina Total Care Flea Knockdown For Medium and Large Dogs.
Elanco Australasia advise the recall is because of an ‘oversticker’ on the product containers that covers the active constituent and that there is no quality or safety impact for the product. People who have the products should direct any questions to Elanco Australasia.
Products can be recalled for a variety of reasons and we encourage manufacturers to issue a voluntary recall if an issue is detected.
New tailored guidance material: reference products
We’re making registration easier with tailored guidance material that gives you the information you need to lodge the right application, with the right data and supporting evidence to meet APVMA criteria, before entering our online services portal.
A fourth tailored guidance pathway, I want to register a product that is the same as a reference product is now available. This complements the following pathways:
- I want to vary the use of a product to include a new crop, animal species or situation;
- I want to vary a product pack size; and
- I want to vary the sites of manufacture.
By improving applicant guidance material we aim to make the registration process smoother and more efficient.
Learn more about tailored guidance for applicants.
Reminder: Open for public consultation
We are currently seeking input on the following consultations:
- Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code – closes 10 September 2018
- Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code – closes 25 September 2018
- Trade Advice Notice on the proposed use of Starkle 200 SG containing dinotefuran on mung beans – closes 28 September 2018
- Trade Advice Notice on Azoxystrobin and Tebuconazole in the Product Veritas Fungicide for use on Canola and Pulses – closes 1 October 2018
- Representative Crops and Extrapolation Principles for risk assessment and data waivers – closes 5 October 2018
- Methiocarb Proposed Regulatory Decisions – closes 30 November 2018
- Phone our general enquiries number: +61 2 6210 4701
- Email: firstname.lastname@example.org
- Our mailing address is:
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston, Australian Capital Territory 2604