April 14, 2017
USA

Patrick Kennedy_Mérieux NutriSciences USA

USA - FDA Issues Guidance to Implement FSMA Program for Foreign Suppliers

Issued the final guidance for Model Accreditation Standards
Mérieux NutriSciences export

As mandated by the Food Safety Modernization Act (FSMA), foreign food suppliers might need to use accredited third-party certification bodies and obtain certifications for special circumstances.
The use of accredited third-party certification bodies is required to establish eligibility for a foreign supplier to participate in the Voluntary Qualified Importer Program, known as VQIP, which offers an expedited review and entry of food into the United States.  Moreover, the U.S. Food and Drug Administration (FDA) can require that a high-risk food offered for import be accompanied by a certification from an accredited third-party certification body.  

In December 2016, FDA issued the rule for user fees and the long-awaited final guidance for Model Accreditation Standards.  

Accreditation bodies will evaluate third-party certification bodies for accreditation, monitor the performance of certification bodies, conduct self-assessments, and submit reports and other notifications to FDA as stipulated by the final rule. While the program has not yet launched, FDA has estimated fees for the FY 2017 participation including application fees and an annual fee applicable to a recognized accreditation body and certification body.   The agency will publish its FY2018 rates during CY 2017.

The complete news is available in Regulatory Update Online - Click here to ask for a free trial.

Source: U.S. Food and Drug Administration

Questions? Comments? Concerns?

CONTACT US!

T: +39 045 82 83 311
E: regulatory.services@mxns.com

For more information
about Mérieux NutriSciences visit

www.merieuxnutrisciences.com

Fill out this form and you will be contacted as soon as possible.

*
To prevent automated spam submissions leave this field empty.
*

The personal data you mentioned will be processed by Chelab S.r.l. - Socio Unico, data controller, to answer to your request. Your data may be transferred to one of the affiliated entities of Chelab S.r.l. - Socio Unico located or not within the EU, which will process them in accordance with your content request.

You have the right to access to your data, request rectification, erasure, restriction of processing or withdrawal and may exercise this right by sending your request by email to contact.italy@mxns.com.