Wednesday, September 24, 2014 - Mark Humph
CHANGES TO THE CONDITIONS FOR TRADE IN GERMINAL PRODUCTS UNDER COUNCIL DIRECTIVE 92/65/EEC
Main changes coming into force on 1 October 2014:
The main changes introduced by Commission Implementing Regulation 846/2014/EU (which amends Annex D to Directive 92/65/EEC) are as follows:
Equine 1. It allows an option to use the polymerase chain reaction (PCR) or real-time PCR to test for both CEM (swabs) and EVA (semen). A PCR for CEM is available at AHVLA Penrith. However, a PCR is not currently available at AHVLA for EVA, but an update will be provided when it is (in a few weeks time, it is expected).
2. Where a PCR for CEM is deployed, samples only need to be collected and tested on one occasion (as opposed to two - at least 7 days apart - if intended for culture) in the following circumstances:a. Semen collected under programme 2, where routine tests for CEM are required within 60 days prior to the collection of semen intended for trade.[However, at the beginning of the breeding season, samples must continue to be collected and tested on two occasions - 14 days after the 30 day residency has started and at least 7 days apart.]b. Embryo collection, where the test for CEM is required within 30 days prior to collection.
3. For semen collected under programme 2, routine testing every 90 days for EIA, every 30 days for EVA (unless stallion is seropositive in which case its semen needs to be tested every 6 months) and 60 days for CEM is no longer required, but the test must have been carried out within these timescales prior to collection of every batch of semen intended for trade.
4. Samples (swabs) for CEM (culture or PCR) must be collected at least seven days (in the case of systemic treatment) or 21 days (in the case of local treatment) after any antimicrobial treatment has been carried out on the donor stallion.
5. The following samples for CEM are no longer required: Pre-ejaculatory fluid in the case of semen and endometrial cervix in the case of embryos.
All Balai species
6. Embryos: the zona pellucida (or the embryonic capsule in the case of equines) must be examined at not less than 50 x magnification (as opposed to 40 x currently). Only then can they be certified as intact and free of adherent material.Further clarification provided by the EU Commission
7. If semen collected under programmes 1 and 2 is frozen, it can NO longer be exported immediately and MUST be stored for at least 30 days before it can be certified for trade.
8. For CEM (culture or PCR), the swabs cannot be pooled. Therefore, separate swabs must be submitted as follows:a. For semen: from the penile sheath (prepuce), the urethra and the fossa glandis (i.e. 3 separate swabs);b. For embryos: from the mucosal surfaces of the clitoral fossa and clitoral sinuses (i.e. 2 separate swabs; there are three clitoral sinuses – the left lateral, the median and the right lateral - but one swab can be used for these).Certifcation (ITAHCs)
9. Separate certificates to enable trade in Balai germinal products collected from 1 October under the amendments introduced by Commission Implementing Regulation 846/2014/EU are yet to be adopted. A further update will be provided when they are.
Full Customer Information Note available here
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