Serum Industry Regulatory News

The ISIA Regulatory Team continually monitors world-wide regulations that affect the serum industry.
We post important updates and/or new industry regulation information to LinkedIn, Facebook, and to our website.

ADVANCE NOTICE: USDA Announces Final Rule to Amend Veterinary Services’ User Fee Regulations.
IMPORTANT: VS Form 16-4 transition period ending
IMPORTANT: New VS Form 16-4 and transition period
The proposed conditions include changed requirements for sourcing FBS, as well as additional treatment and testing procedures.
The USDA is requesting comments on the proposed new requirements for the “Product of USA” Label.
Inspection Date Grace Period Policy Temporarily Extended Through February 1, 2023 for certain eligible facilities
USDA - Inspection Date Grace Period Policy Temporarily Extended through December 31, 2022
APHIS Veterinary Services Requires eFile System for all New and Renewal Permit Applications - Effective May 31, 2022
APHIS - Inspection Date Grace Period Policy Temporarily Extended through September 30, 2022
USDA Seeks Comments on the Labeling of Meat and Poultry Products Derived from Animal Cells
APHIS Extends Export Product Facility Inspection Grace Period through September 30, 2021
APHIS Expands International Services to Emerging Markets
USDA APHIS Extends Updated Interim Guidance for Veterinary Health Certificates through December 31, 2020
APHIS Awards Contracts to Provide up to Eight Million Low-Frequency Radio Frequency Identification Tags to Cattle and Bison Producers

Update on Importing Brazilian Origin FBS into China
Taiwan: Changes to certification requirements for the export of bovine serum
Notification from DAFF - European Union: Amendments to export health certification for animal inedible products
2020 New Zealand Regulations for Exporting Animal Products
Taiwan- Quarantine Requirements for Bovine Serum for Technical Use Amended

DEFRA - New import controls now Live
DEFRA - The Border Target Operating Model – Compliance and Enforcement Approach January 31 to April 30 2024
The UK model health certificates that have been amended with the changes that were published in October/December 2022 and are now active and available for use.
Statement on the introduction of planned import controls on EU goods from July 2022
DEFRA - New Import Controls for Animal Products
New EU regulation 2002/384 from 4 March 2022 - amending third country lists
Reminder – IPAFFS pre-notification required for animal products from European Union (EU) into Great Britain (GB). From January 2022, you must pre-notify your consignment via IPAFFS
Information concerning the activation of the DOCOM module in TRACES-NT and the closure of the DOCOM module in TRACES Classic
New Phased Approach to Import Controls for Products of Animal Origin and Animal By-Products from the European Union (EU).
New GB Model Certificates Now Available in iRegs!
Latest on Importing Animal Products from the European Union into Great Britain
Extension to grace period for continued acceptance of EU model health certificates in UK- OV NOTICE
UK News/Defra Provides New Timeline for Border Control Processes on Import of Sanitary and Phytosanitary Goods from the EU
Defra Webinars Available
EU Guidance Note: Withdrawal of the United Kingdom and EU Rules in the Field of Customs, Including Preferential Origin
Locating Export Health Certificates for Technical Product (ABP): UK-EU
Register Now for IPAFFS for High Risk Feed and Feel not of Animal Origin
Israel: New Certificate for Blood for Technical Uses for All Species
IPAFFS - System for Import of Animal Products into Great Britain/Important Dates and Information
European Commission has decided NOT to transition to TRACES NT in early September
131 Top Forms Online Submission Only - Export Health Certificates (3rd countries)
ANNOUNCEMENT - Switch to IPAFFS for POAO/CHED-P import notifications on 7 Sept 2020
CALL TO ACTION - 2 weeks to go until switch to IPAFFS for GB import notifications - POAO/CHED-P
Countdown: GB Importers - Those responsible for load - Switch to IPAFFS for POAO/CHED-P import notifications on 7 Sept 2020
APHIS - Notice on Live Animal Import and Transit Permits. Effective Immediately

Serum Importation from USA into Mexico - ISIA Statement
131 Top Forms Online Submission Only - Export Health Certificates (3rd countries)
APHIS Awards Contracts to Provide up to Eight Million Low-Frequency Radio Frequency Identification Tags to Cattle and Bison Producers
ANNOUNCEMENT - Switch to IPAFFS for POAO/CHED-P import notifications on 7 Sept 2020
CALL TO ACTION - 2 weeks to go until switch to IPAFFS for GB import notifications - POAO/CHED-P
Countdown - GB Importers/those responsible for load - Switch to IPAFFS for POAO/CHED-P import notifications on 7 Sept 2020
APHIS - Notice on Live Animal Import and Transit Permits
Notification from DEFRA - POAO 3rd country imports notifications - changes to systems - This was submitted to ISIA as having High Importance
Regulation (EU) 2020/762 amending Regulation (EU) No 142/2011
Commission Implementing Regulation (EU) 2020/714
Extended Immediately through July 18, 2020: USDA APHIS Allows Copies of Veterinary Health Certificate in ACE-DIS for Shipment Clearance due to COVID-19 Pandemic
Message from USDA APHIS -- EU -HPAI ban on the Entire United States: Effects Certificates for Most Poultry Derivatives that are not highly processed: 3E, 3F, 4C, 8, and RCG
USDA APHIS Allows Copies of Veterinary Health Certificate in ACE-DIS due to COVID-19
TRACES.NT registration
TRACES NT users - TRACES NT users – completion of box I.28 to avoid delays to consignments
Slide deck with details
Transition to TRACES - New Technology for Live Animals 01:00 GMT 5 March 2020
URGENT - Importers of live animals, POAO or HRFNAO from outside the EU must prepare for system changes next week
Feb. 13 - Importers of HRFNAO from outside the EU must use TRACES NT now.
TWO NEW REGULATIONS FROM DEFRA: Smarter Rules for Safer Food.
UK will leave the European Union on 31st January 2020
DEFRA Import and Export Newsletter
Brexit Podcasts links

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