The procedure that ensures that materials entering the site have a known allergen status and that allergen information remains accurate throughout the life of the ingredient.

Why have a raw material approval process?

An effective procedure helps ensure:

  • Accurate ingredient declarations
  • Appropriate precautionary allergen labelling (PAL) decisions
  • Reduces the likelihood of allergens being unknowingly added to a product.
  • Information inform effective management of the material in the plant
  • Reduces risks from material changes or alternative suppliers.

When to apply the process

The process should be applied whenever:

  • New materials are introduced
  • Suppliers are changed
  • Specifications are updated
  • Periodic reviews are due

What should the procedure define?

Specification management

The procedure should describe:

  • How specifications are obtained
  • Approved specification formats
  • Document control requirements
  • Review frequencies
  • Version control requirements
  • Who is responsible

Current information should be maintained within a controlled specification library.

Allergen review requirements and documentation

The procedure should define how allergen information will be reviewed, including:

  • Intentionally present allergens
  • Derived allergen sources
  • Processing aids
  • Cross contact allergens
  • Unexpected allergens

See raw material risk review

Information quality criteria

The procedure should define what is considered acceptable information and how confidence in information will be assessed. Examples may include:

  • Product Information Form (PIF) review
  • Supplier declarations
  • Certificates of Analysis
  • Analytical results
  • Supporting evidence to be requested such as cleaning validation information.

Additional verification requirements

The procedure may define circumstances requiring:

  • Incoming material testing
  • Ongoing monitoring frequency
  • Certificates of Analysis
  • Additional supplier information

Change management

The process should establish controls for:

  • Supplier changes
  • Site changes
  • Formulation changes
  • Manufacturing changes
  • Changes to allergen status

Before any change is implemented:

Reviews should be completed before changes are implemented.

Outcome of the procedure

The raw material approval process ensures that materials used by the business:

  • Have current allergen information
  • Have undergone allergen review with outcomes documented
  • Have been approved through a documented approval process
  • Have any required monitoring controls established
  • Support accurate consumer information