The GMIA Regulatory Committee continuously monitors regulations within North America and the concern of gelatin and its uses along with sister gelatin organizations around the world.  Below you will find important links to sister gelatin organizations and agency regulations.

REGULATORY INFORMATION & UPDATES



August 24, 2016 - FDA releases Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This guidance is basically non-binding.  Comments on the guidance can be submitted before February 21, 2017.  This guidance is intended to help you comply with the following specific PCHF requirements established in subparts C and G of 117:

A written food safety plan (FSP)

Hazard analysis

Preventative Controls

Monitoring

Corrective Actions

Verification; and

Associated records 

A link to the guidance can be found at:   https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-20177.pdf


April 5, 2016 - FDA releases Final Rule on Sanitary Transportation of Human and Animal Food under FSMA

You can learn more about the rule at:  http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm


November 13, 2015 - FDA release final rules in under FSMA (Food Safety Modernization Act)

Final Rule on Produce Safety

FInal Rule on Foreign Supplier Verification Programs (FSVP) for Importer of Food for Humans and Animals

Final Rule on Accredited Third-Party Certification

For more details visit:  http://www.fda.gov/Food/GuidanceRegulation/FSMA/


July 7, 2015 - EU notified WTO on proposed changes to Regulation (EC) No. 853/2004 which are specific requirement for gelatin, collagen and highly refined products of animal origin intended for human consumption and Regulation (EC) No. 2074/2005, drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements. 


June 5, 2015 - FDA issues Draft Guidance for Industry:  FDA's Voluntary Qualified Importer Program. The draft guidance describes VQIP, which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program.

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm448728.htm


March 4, 2014 - Effective date of the APHIS - BSE; Importation of Bovines and Bovine Product also known as the BSE Comprehensive Rule. 

http://www.federalregister.gov/articles/2013/12/04/2013-28228/bovine-spongiform-encephalopathy-importation-of-bovines-and-bovine-products


January 30, 2014 - FSMA Website

FSMA (Food Safety Modernization Act) website can be found here:  http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

 

December 4, 2013 - BSE Comprehensive Rule Published

To be effective March 4th, 2014.  This is in regard to importation of animals and animal products to revise the conditions for the importation of live bovines and products derived from bovines with regard to bovine spongiform encephalopathy (BSE). The USDA is basing importation conditions on the inherent risk of BSE infectivity in specified commodities, as well as on the BSE risk status of the region in which the commodities originate. They are establishing a system for classifying regions as to BSE risk that is consistent with the system employed by the World Organization for Animal Health (OIE).

 

July 26, 2013 - FMSA New Proposed Rules

FDA issues two proposed rules under the Food Safety Modernization Act (FSMA) aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically.

Proposed Rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

Proposed Rule on Accreditation of Third-Party Auditors.Certification Bodies to Conduct Food Safety Audits and to Issue Certifications


July 23, 2013 - The GSP (Generalized System of Preferences)The U.S. Generalized System of Preferences (GSP) is a program designed to promote economic growth in the developing world.  On October 21, 2011, President Obama signed legislation to reauthorize the GSP program through July 31, 2013.  The House Ways and Means leaders introduced legislation to renew GSP through September 30, 2015. This is a positive first step but the House will not actually vote on the bill until the Senate approves similar legislation. Follow the link for more information on the GSP.

August 3, 2012 - FSMA Information
The FDA Food Safety Modernization Act (FSMA) mandates that all food facilities that are required to register must renew their registrations every other year during the period beginning on October 1st and ending on December 31st of each even-numbered year. The first registration renewal cycle will occur from October 1 to December 31, 2012.Registrants can renew food facility registrations online or submit the paper Form 3537 by mail or fax.  FDA encourages online registration as the least costly, quickest, and most efficient means for food facility registration. All food facilities that are required to register with FDA under section 415 of the FD&C Act, including foreign facilities (as defined in 21 CFR 1.227(b)(2))
 
Registrants are required to submit registrations to FDA containing the information.

Biennial Registration Renewal for Food Facilities began at 12:01 AM on October 22, 2012. The updated food facility registration system is accepting food facility registration renewals.
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GELATINE MANUFACTURERS OF EUROPE

SOUTH AMERICAN GELATIN MANUFACTURERS ASSOCIATION

GELATIN MANUFACTURERS ASSOCIATION OF ASIA PACIFIC

Important Regulatory Links & Statements 

Since products and regulatory situations are different among companies and their products, it is always in your best interests to check with your regulatory authorities for the most accurate information meeting your own requirements.