Item
Dummy Item BRZ (Questionnaire Master Item - Brazil)
Dummy item to complete item specific questionnaires to copy from.
We, PB Brasil Indústria e Comércio de Gelatinas LTDA., Division of Tessenderlo Group, hereby certify: Fourteen (14) allergens are listed in Annex II of Regulation (EU) 1169/2011. They are cereals containing
gluten (wheat (such as spelt and Khorasan wheat), rye, barley, oats or their hybridized strains),
crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame, sulfur dioxide and
sulfites at concentrations above 10 mg/kg, lupin, molluscs and products derived thereof.
Food Allergen Labeling Consumer Protection Act (FALCPA) identifies the following foods or food groups
as the major food allergens.: milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab,
lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, sesame and soybeans.
We, the undersigned, hereby state that the food grade and the pharmaceutical grade gelatine
produced by:
‐ Tessenderlo Group NV, division PB Leiner in Vilvoorde Belgium,
‐ PB Gelatins GmbH in Nienburg, Germany,
‐ PB Gelatins UK Ltd. in Treforest, United Kingdom,
‐ PB Leiner S.A. in Santa Fe, Argentina,
‐ PB Leiner USA in Davenport, USA,
‐ PB Brasil Industriae E Comercio de Gelatinas Ltda in Acorizal, Brazil and/or
‐ PB Gelatins Heilongjiang Co., Ltd. in Nehe city, P.R. China,
do not contain any substances listed as allergen in Annex II of Regulation 1169/2011 and in the FALCPA,
with the exception of sulphur dioxide, which is generally present at levels lower than 40 mg/kg.
As a result of the harmonisation, the European Pharmacopeia, the US Pharmacopeia and the
Japanese Pharmacopeia last editions specify a limit of 50 mg Sulphur dioxide/kg gelatine. The same
limit is specified in Annex III of Regulation (EC) No 853/2004 laying down specific hygiene rules for food
of animal origin as last amended.
The abovementioned companies produce exclusively gelatine on the gelatine production lines. All the
gelatines are handled and transported in a manner in order to prevent subsequent contamination of
the product.
That the gelatine we produce in our plant is 100% beef hide gelatin.
Locations
Location name | Address |
---|---|
PB LEINER BRAZIL | COP: 78480-000 ZONA URBANA MATO GROSSO, BRAZIL 79010 BRA |
Documents
Type | Location | File name | Effective | Expiration |
---|---|---|---|---|
Allergens | PB LEINER BRAZIL | Allergens - BRAZIL (ITEM) 1.28.25 - 1.28.27.pdf | 1/28/2025 | 1/28/2027 |
Country of Origin | PB LEINER BRAZIL | Country of Origin - BRAZIL (ITEM) 1.28.25 - 1.28.28.pdf | 1/28/2025 | 1/28/2028 |
Dietary Supplement Questionnaire | PB LEINER BRAZIL | Dietary Supplement Questionnaire - BRAZIL (ITEM) 1.28.25 - 1.28.26.pdf | 1/28/2025 | 1/28/2026 |
FSVP Assessment Form | PB LEINER BRAZIL | FSVP Assessment Form - BRAZIL (ITEM) 1.28.25 - 1.28.26.pdf | 1/28/2025 | 1/28/2026 |
Item Questionnaire | PB LEINER BRAZIL | Item Questionnaire - BRAZIL (ITEM) 1.28.25 - 1.28.28.pdf | 1/28/2025 | 1/28/2028 |
National Bioengineered Food Disclosure Standard (Simplified) | PB LEINER BRAZIL | National Bioengineered Food Disclosure Standard (Simplified) - BRAZIL (ITEM) 1.28.25 - 1.28.28.pdf | 1/28/2025 | 1/28/2028 |
Nutrition | PB LEINER BRAZIL | Nutrition - BRAZIL (ITEM) 1.28.25 - 1.28.28.pdf | 1/28/2025 | 1/28/2028 |
Suitability Requirements | PB LEINER BRAZIL | Suitability Requirements - BRAZIL (ITEM) 1.28.25 - 1.28.28.pdf | 1/28/2025 | 1/28/2028 |

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