KGP FDA
Free Preliminary Assessment

Labeling and Content

Allergen Risk Assessment

Fee: $99 / product

Allergen lists vary by market: the US has 9 major allergens, the EU and Great Britain have 14; Canada’s list also includes mustard and mollusks. In the US, the preventive controls of facilities registered with FDA also include allergen controls to prevent allergen cross-contact.

Who Is Obligated?

Companies that export food to more than one market or produce products containing different allergens on the same line.

What We Do

  • We screen your recipe and raw materials against each market’s allergen list.
  • We assess the risk of cross-contact on the production line.
  • We prepare the allergen declaration on the label according to the market’s rules.

What You Receive

  • Allergen risk assessment report
  • Allergen declaration text by market

Allergen Risk Assessment Application

Ingredient, production line and cleaning details so we can assess your products against the target markets' allergen lists and prepare the cross-contact risk assessment and label statement.

  1. 1 Market and Products
  2. 2 Line and Cleaning
  3. 3 Label
  4. 4 Submit
1. Market and Products
Target market(s) *
Recipe and raw material specifications

Supplier specifications show the allergen information. PDF, image, Word or Excel; up to 5 files per field, 25 MB in total for the whole form.

Allergens contained in the products

The list combines the US, EU, UK and Canada allergen lists.

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

Is the allergen list the same in every market?
No. The US has 9 major allergens, the EU and Great Britain have 14; Canada’s list also includes mustard and mollusks. An ingredient that requires no declaration in one market may require one in another.
Who is this assessment important for?
Companies that export food to more than one market and produce products containing different allergens on the same line. In the US, the preventive controls of facilities registered with FDA also include allergen controls to prevent allergen cross-contact.
What information do you need from us?
Your recipes, raw material information and the list of products made on the same line. With these we screen against each market’s allergen list and assess the risk of cross-contact.
What do you deliver at the end of the assessment?
An allergen risk assessment report and, for each market, the allergen declaration text to go on the label. The assessment also provides input to your food safety plan under HACCP and BRCGS Documentation.

Sources: FDA: Food Allergies; 21 CFR 117.135; Tüzük (AB) 1169/2011, Md. 21 ve Ek II; Regulation 1169/2011 (GB), Article 21; Food and Drug Regulations (C.R.C., c. 870), B.01.