Brewer's Yeast Supplier Certifications: ISO 22000, HACCP, GMP and FDA Registration Explained

In short: HACCP is a method for controlling hazards, GMP is the set of hygiene and operating conditions a plant runs under, and ISO 22000 is a certified management system that contains both. FDA facility registration is a separate legal requirement for any plant shipping food or feed to the United States. TBESBY dried brewer's yeast is produced under ISO 22000:2018 at facilities registered with the U.S. FDA.

Supplier offers list certificates in different combinations, and the acronyms overlap. This guide is for quality managers, regulatory staff and buyers who approve ingredient suppliers for pet food and feed. It explains what each scheme covers, how the schemes relate, and what to file when you qualify a manufacturer of dried brewer's yeast.

What does each scheme cover?

How do ISO 22000, HACCP and GMP relate?

They are layers of one system. GMP conditions, which ISO 22000 calls prerequisite programmes, form the base. The HACCP plan sits on top of them and controls the specific hazards of the process. ISO 22000 adds the management layer: documented responsibilities, internal audits, corrective action, management review and an external audit by a certification body. A manufacturer certified to ISO 22000:2018 is therefore operating a HACCP plan and prerequisite programmes as part of that certification.

What are the seven HACCP principles?

HACCP is defined in the Codex Alimentarius General Principles of Food Hygiene (CXC 1-1969, revised in 2020). Every HACCP plan, whatever the product, is built on the same seven principles:

1. Conduct a hazard analysis and identify control measures.
2. Determine the critical control points.
3. Establish validated critical limits.
4. Establish a system to monitor each critical control point.
5. Establish the corrective actions to take when monitoring shows a deviation.
6. Validate the plan and verify that it is working.
7. Keep documentation and records.

For a drum-dried yeast, the drying step is the obvious place a hazard analysis looks first, because it is where heat inactivates the yeast and reduces moisture to a level at which the powder is stable. A buyer auditing any yeast producer can ask to see how that step is monitored and recorded.

What does ISO 22000:2018 add on top?

ISO 22000:2018 takes the Codex principles and places them inside a management system with the same clause structure as ISO 9001. The standard applies to any organisation in the food chain, and it names feed producers in its scope. Beyond the hazard control plan, an auditor checks for a food safety policy with objectives, defined responsibilities, competence and training records, control of suppliers and externally provided processes, a traceability system, emergency preparedness, a procedure for handling nonconforming product and withdrawals, internal audits and management review. A certification body audits the site against all of this and returns for surveillance audits during the certificate's three-year cycle.

What does FDA registration involve for a foreign facility?

Under section 415 of the US Federal Food, Drug, and Cosmetic Act, domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register with the FDA. The Food Safety Modernization Act added a renewal every other year, in a window that runs from 1 October to 31 December, and the FDA treats a registration that is not renewed as expired. A foreign facility also names a US agent. On the importer's side, the Foreign Supplier Verification Programs rule makes the US importer responsible for verifying that its foreign supplier produces food to US safety standards, which is why importers ask for the documents listed below.

How do you read a certificate in two minutes?

• Scope. The scope statement should name the product or process you are buying, for example the production of dried brewer's yeast.
• Site. The address on the certificate should be the site that makes your goods.
• Certification body. Look for the body's name and the mark of the accreditation body that oversees it.
• Dates. Check the issue and expiry dates, and diarise the expiry so you request the renewed certificate.
• Standard and version. ISO 22000:2018 is the current edition.

What does TBESBY hold?

• ISO 22000:2018 food safety management system certification.
• U.S. FDA food facility registration, renewed and valid through 2028.
• Non-GMO: screening for genetically modified material, not detected.
• A certificate of analysis with every lot, and retained samples.

Details are on our quality and certificates page. Copies of current certificates are sent on request during supplier approval.

Which documents should an importer keep on file?

1. The current food safety certificate, with scope, certification body and expiry date.
2. For the United States: confirmation of FDA facility registration, which the importer needs for prior notice and for its Foreign Supplier Verification Program records.
3. The product specification and a recent certificate of analysis.
4. A completed supplier questionnaire and, where your programme requires it, a statement on raw material origin.
5. Market-specific declarations, such as the EU and UK feed material name or the Australian import permit conditions.

Market rules are covered in our import guides for the USA and the EU, and the wider approval process in the 10-point supplier checklist.

To start supplier approval, request the TBESBY document set.

Sources

• Codex Alimentarius Commission. General Principles of Food Hygiene, CXC 1-1969, revised 2020.
• ISO 22000:2018, Food safety management systems: Requirements for any organization in the food chain.
• U.S. Food and Drug Administration. Registration of Food Facilities and Other Submissions; Food Facility Biennial Registration Fact Sheet.
• U.S. Food and Drug Administration. FSMA Final Rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.