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E.U. Certification Program Final, Effective January 1

Nov 30, 2011

The Agricultural Marketing Service of the U.S. Department of Agriculture last week held a meeting with industry stakeholders, including IDFA, to discuss its proposed certification program to meet European Union requirements for somatic cell and standard plate counts for raw milk. AMS representatives outlined logistical details and answered questions before finalizing the European Union Health Certificate Program.

The program outlines how U.S. producers and processors will be required to demonstrate compliance with E.U. regulations when exporting dairy products to the 27 member countries. The effective date for beginning the transition to the new requirements is January 1, 2012. After March 1, 2012, all shipments of dairy products that require an E.U. health certificate must comply with the program and be accompanied by an updated Certificate of Conformance.

IDFA previously expressed general support for the program and submitted comments to AMS asking for clarification on sample size, recordkeeping and proof of compliance. These issues have all been addressed in the final program.

“IDFA has worked with USDA, the Food and Drug Administration and other industry stakeholders since last year to build a strong program that seeks to minimize negative industry impact while also facilitating the ability to export our products,” said John Kelly, IDFA manager of international affairs. “We are thankful to all those who put a great deal of time and effort into the program.”

The major difference between the United States and E.U. milk requirements is the maximum limit on somatic cell and standard plate counts for raw milk. Although the federal threshold in the United States is 750,000 cells per milliliter of milk, the standard set by the Pasteurized Milk Ordinance, the national average based on the Dairy Herd Improvement Association and USDA Federal Milk Market records is around 300,000 cells. The E.U. threshold is set at 400,000 cells.

Highlights of the European Union Health Certificate Program

  • Milk suppliers, dairy processors and applicants for E.U. Health Certificates are responsible for maintaining records to trace their products back one step in the supply chain for dairy products and ingredients intended for export to the European Union. 
  • Processors of dairy products and ingredients that require an E.U. Health Certificate will be responsible for maintaining Certificates of Conformance demonstrating that the products meet the new requirements. 
  • It is the responsibility of milk suppliers to provide Certificates of Conformance to processors and maintain records of individual farms to confirm that the raw milk meets the new requirements.   
  • The farm-level milk supply must be tested to document compliance with the requirements.

Farms will have three months to establish the initial rolling three-month means; data collected in January, February and March will be used to determine the rolling three-month mean for April. Non-Grade A farms will have January and February to establish initial rolling two-month means. If a rolling mean exceeds E.U. requirements, the milk supplier must notify AMS.

An important element of the program is the “derogation,” or exemption, that allows milk from farms having difficulty meeting the E.U. regulations to be used in virtually all dairy products exported to the European Union. The derogation is conditional; farms must take action to improve their counts or demonstrate that the non-compliant counts were caused by normal seasonal variations.

Dairy processors whose products may be going to the European Union for export should be sure to request Certificates of Conformance from their milk suppliers verifying compliance with the E.U. regulations, Kelly said.

For more information, contact Jonathan Gardner, IDFA vice president of regulatory and international standards, at or (202) 220-3544, or Kelly at or (202) 220-3507.

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