Item
Type B 250 Bloom 40 Mesh (10000136)
We, PB Leiner Brasil, 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.
Attributes
- Halal
- Ingredient declaration
- Kosher
- PHO-free
- Non-GMO
Locations
Location name | Address |
---|---|
PB LEINER ARGENTINA | 3017 SAUCE VIEJO SANTA FE SANTA FE, ARGENTINA 52806 ARG |
PB LEINER BRAZIL | COP: 78480-000 ZONA URBANA MATO GROSSO, BRAZIL 79010 BRA |
Documents
Type | Location | File name | Effective | Expiration |
---|---|---|---|---|
Halal | PB LEINER BRAZIL | 0055 Sif 1233 PB Brasil - Acorizal MT.pdf | 11/21/2024 | 11/21/2027 |
Pesticide | PB LEINER BRAZIL | 043 - Statement - Pesticides.pdf | 12/19/2023 | 12/18/2025 |
Irradiation Status Statement | PB LEINER BRAZIL | 088 - Statement Latex Allergy.pdf | 1/30/2024 | 1/29/2026 |
GMO | PB LEINER BRAZIL | 133 Statement GMO.pdf | 9/4/2024 | 9/4/2026 |
Allergens | PB LEINER BRAZIL | Allergens.pdf | 1/27/2025 | 1/27/2027 |
California Prop. 65 | PB LEINER BRAZIL | California Proposition 65 List 7.4.23 - 12.31.28.pdf | 7/4/2023 | 7/3/2025 |
Country of Origin | PB LEINER BRAZIL | Country of Origin.pdf | 3/3/2025 | 3/2/2028 |
Product Specification Sheet | PB LEINER BRAZIL | CS STO 25040 PB USA Stock rv.05.pdf | 1/27/2025 | 1/27/2028 |
CoA Sample | PB LEINER BRAZIL | DELIVERY 80138167 - Item 900002 - L4124 - data 04.04.2024.pdf | 4/4/2024 | 4/4/2026 |
Dietary Supplement Questionnaire | PB LEINER BRAZIL | Dietary Supplement Questionnaire.pdf | 2/21/2024 | 2/20/2025 |
EtO Statement | PB LEINER BRAZIL | Ethylene Oxyde (ETO) 7.19.21 - 7.19.26.pdf | 7/19/2024 | 7/19/2026 |
FSVP Assessment Form | PB LEINER BRAZIL | FSVP Assessment Form.pdf | 1/28/2025 | 1/28/2026 |
GMO | PB LEINER ARGENTINA | Genetically Modified Organisms (GMO) 2.2.20 - 12.31.25 .pdf | 1/1/2024 | 12/31/2025 |
GRAS/NDI/ODI Statement | PB LEINER BRAZIL | GRAS Status Statement 9.30.22 - 9.30.27.pdf | 9/30/2024 | 9/30/2027 |
HACCP | PB LEINER BRAZIL | HACCP - HARPC Program - Acorizal 1.12.24 - 12.31.26.pdf | 1/1/2024 | 12/31/2026 |
Ingredient Statement | PB LEINER BRAZIL | Ingredient Statement (US Brazil & Argentina) - 3.5.24-12.31.26.pdf | 12/31/2025 | 12/31/2026 |
Item Questionnaire | PB LEINER BRAZIL | Item Questionnaire.pdf | 2/21/2024 | 2/20/2027 |
Kosher | PB LEINER BRAZIL | Kosher 2025 - Acorizal.pdf | 3/3/2025 | 3/3/2027 |
Label Sample | PB LEINER BRAZIL | Label Sample - Acorizal.png | 1/1/2025 | 1/1/2026 |
Lot Code | PB LEINER BRAZIL | Lot Code System - Acorizal 2.1.22 - 12.31.25.pdf | 1/1/2023 | 12/31/2025 |
Melamine | PB LEINER BRAZIL | Melamine Statement 5.19.23 - 12.31.28.pdf | 1/1/2028 | 12/31/2028 |
National Bioengineered Food Disclosure Standard (Simplified) | PB LEINER BRAZIL | National Bioengineered Food Disclosure Standard (Simplified).pdf | 2/21/2024 | 2/20/2027 |
Finished Good Document Packet | PB LEINER BRAZIL | NotApplicable_FinishedGoodDocumentPacket.pdf | 3/6/2024 | 3/6/2026 |
Nutrition | PB LEINER BRAZIL | Nutrition.pdf | 1/27/2025 | 1/27/2028 |
Phthalate Esters Letter | PB LEINER BRAZIL | Phtalates Statement - 8.22.22 - 12.31.25.pdf | 12/31/2024 | 12/31/2025 |
Residual Statement | PB LEINER BRAZIL | Residual Solvents - Bovine Gelatin 8.19.21 - 7.31.26.pdf | 7/31/2025 | 7/31/2026 |
HARPC Food Safety Plan (Item) | PB LEINER BRAZIL | RS QA 003B_15.pdf | 3/6/2024 | 3/6/2027 |
HACCP Process Flow Diagram | PB LEINER BRAZIL | RS QA 026 Process Flow Chart Halal rv.8.pdf | 1/9/2024 | 1/8/2026 |
Safety Data Sheet (SDS) | PB LEINER BRAZIL | SDS Gelatin Edition 17.pdf | 2/23/2023 | 2/22/2026 |
Sewage Statement | PB LEINER BRAZIL | Sewage Sludge 12.28.23 - 12.31.28.pdf | 1/1/2027 | 12/31/2028 |
Shelf Life | PB LEINER BRAZIL | Shelf Life and Stability (Gelatin) 1.16.23 - 12.31.28.pdf | 1/1/2027 | 12/31/2029 |
Heavy Metal | PB LEINER BRAZIL | Statement 032 Heavy Metals_Brazil 2024_2027 ed.4.pdf | 2/8/2024 | 2/7/2026 |
Suitability Requirements | PB LEINER BRAZIL | Suitability Requirements.pdf | 1/27/2025 | 1/27/2028 |

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