Intralox White TPE Compliance Letter

Intralox, L.L.C.
P.O. Box 50699, New Orleans, LA 70150-0699, U.S.A.

Receptionist: 504-733-0463 Fax: 504-734-0063
Toll Free in the U.S. and Canada: 800-535-8848
Toll Free in Mexico: 800-010-0354
Internet: http://www.intralox.com
Issue Date: April 4, 2022
Dear Valued Customer,
The following is in response to your request regarding the material Intralox uses in the
manufacture of finished articles (conveyor belts) intended for food contact use:
Product: White Thermoplastic Elastomer (37120)

Contact with dry and aqueous foods up to 70 °C for up to 2
Intended Application(s):
hours.
FDA
Our supplier has notified us in writing that the above material complies with the FDA Regulation
21CFR 177.2600 – Rubber Articles Intended for Repeated Use. Samples of the finished article
were tested to the extraction requirements of 21 CFR 177.2600. From the extraction data
obtained, the finished article may be used with the following listed food types for conditions of
use B through G:
I. Nonacid, aqueous products; may contain salt or sugar or both (pH above 5.0)
II. Acid, aqueous products; may contain salt or sugar or both, and including oil-in-water
emulsions of low- or high-fat content.
VI. Beverages containing up to 8% alcohol, nonalcoholic, or containing more than 8%
alcohol.
VII-B. Bakery products other than those included in Types VIII or IX: moist bakery products
with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil.
Canada
Intralox finished articles comply with Part B Division 23 of the Canadian Food and Drug
Regulations. Intralox will provide all supporting compliance documents to the Canadian Food
Inspection Agency (CFIA) upon request.
European Commission
Intralox finished articles comply with:
a. 1935/2004/EC - Materials and Articles intended to come into contact with food,
including Article 3 (General Requirements) and Article 17 (Traceability).
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b. 2023/2006/EC - Good Manufacturing Practice Regulation for materials and articles
intended to come into contact with food. The finished articles are manufactured under a
quality assurance system that meets the requirements of this regulation.
c. Regulation (EU) No.10/2011 on Plastic Materials and Articles Intended to Come into
Contact with Food, including amendments 1282/2011, 1183/2012, 202/2014, 2015/174,
2016/1416 and 2017/752. Monomers, additives and other starting substances are included
in the Union List of authorized substances. A Declaration of Compliance is attached as a
separate document.
d. Regulation (EC) No.1895/2005 - Intralox, L.L.C., does not intentionally use any
BADGE, BFDGE or NOGE material in the manufacturer of articles intended to come
into contact with food.
e. 94/62/EC - regarding concentration levels of heavy metals in packaging: The sum of the
concentrations of lead, mercury, cadmium and hexavalent chromium is less than 100 ppm
by weight.
Other
a. CONEG (Coalition of Northeastern Governors) Model Legislation regarding heavy
metals content: The sum of the concentrations of lead, mercury, cadmium and hexavalent
chromium is less than 100 ppm by weight.
b. Latex: Intralox does not intentionally use latex or natural rubber materials as
plasticizers, additives or raw materials in the belt manufacturing process.
c. Phthalates: Intralox does not intentionally use Butyl benzyl phthalate (BBP), dibutyl
phthalate (DBP), di(2-ethylhexyl) phthalate (DEHP), Diisononyl phthalate (DINP), Di-n-
octyl phthalate (DNOP), or Diisodecyl phthalate (DIDP) as plasticizers, additives or raw
materials in the belt manufacturing process.
d. Bisphenol A: Intralox does not intentionally use Bisphenol A (BPA) as an additive or a
raw material in the belt manufacturing process.
e. Silicone: Intralox does not use low molecular weight silicone in the belt assembly
process. We mold polymers containing high molecular weight silicone, and we have
identified suppliers that may use silicone in their production process. If you need specific
information or an updated list of products that may be manufactured with silicone, please
contact your Customer Service Representative.
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This guarantee is ongoing, generic and is not limited to a specific shipment. It will continue until
revoked in writing by Intralox. An updated statement will be provided if the information on
which the declaration is based changes or regulatory requirements impact its validity. Intralox
believes this information to be accurate and consistent with existing laws, regulations and
standards as they apply to Intralox products on the date this letter was issued. Intralox does not
warrant that its products conform to any laws, regulations and standards relating to public safety,
worker safety, safety guards, sanitation safety, fire safety or any other safety regulations.
Customers should not rely exclusively on this information and should consult the relevant
agency or regulatory body.
Gloria Bowman, Product Stewardship Manager

Intralox, L.L.C.
gbowman@laitram.com
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EU Declaration of Compliance
Plastic Materials Intended to Come Into Contact with Food
Product: White Thermoplastic Elastomer (37120)

Contact with dry, moist and non-acidic aqueous foods up to 70 °C
Intended Application(s):
for up to 2 hours.
This product is in conformity with the applicable requirements of the following regulations:
• (EC) No.1935/2004 on Materials and Articles intended to come into contact with food.
• No. 2023/2006/EC on Good Manufacturing Practice for materials and articles intended to come into
contact with food.
• (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food (including
amendments).
Migration Testing: Data obtained on representative samples of the finished article.
Overall Migration: OM3, 3 x 2 hours at 70 degrees C or equivalent, repeat use.
Migration Mean EU Limit

Test Simulant
(mg/dm2) (mg/dm2) (mg/dm2)
10% ethanol 3.28, 2.99, 3.13 3.1 10
Specific Migration
The following substances associated with the belting have specific migration restrictions (SML’s).
• 1,3-butadiene (Ref No 13630) SML = ND and 1 mg/kg in final product

• Octadecyl 3(3,5-Di-tert-butyl-4-hydroxyphenyl) propionate (Ref No 68320) SML = 6 mg/kg
• 1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (Ref No 95360)
SML = 5 mg/kg
• bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite (Ref No 38820) SML = 0.6 mg/kg
• 9,9-bis(methoxymethyl)fluorene (Ref No 39815) SML = 0.05 mg/kg
For the intended applications of the belting, levels of specific migration of these substances into food
(6dm2 belting/kg food) will not exceed their respective SML restrictions.
FDA Extraction Testing: Data obtained on representative samples of the finished article.
Extraction Mean FDA Limit

Test Simulant
(mg/in2) (mg/in2) (mg/in2)
Distilled Water First 7 Hours Reflux 1.04, 1.28, 1.45 1.3 20
Distilled Water 7-9 Hours Reflux 0.80, 0.71, 0.91 0.81 1
Dual Use Food Additives:

Dual use food additives covered by Regulation (EC) No. 1333/2008 are used in the manufacture of the
belting, but levels of any migration will be minimal and will not have a technological function in food.
This Declaration is valid for 2 years from 4-Apr-22. Updated statements will be provided if the
declaration’s validity is affected by changes in the information or regulatory requirements.
Intralox, L.L.C.
P.O. Box 50699, New Orleans, LA 70150-0699, U.S.A.
Receptionist: 504-733-0463 Fax: 504-734-0063
Toll Free in the U.S. and Canada: 800-535-8848
Gloria Bowman, Product Stewardship Manager Toll Free in Mexico: 800-010-0354
gbowman@laitram.com Internet: http://www.intralox.com

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Intralox, L.L.C.

P.O. Box 50699, New Orleans, LA 70150-0699, U.S.A.

Issue Date: April 4, 2022

Dear Valued Customer,

Product: White Thermoplastic Elastomer (37120)

Gloria Bowman, Product Stewardship Manager

Product: White Thermoplastic Elastomer (37120)

Migration Mean EU Limit

• 1,3-butadiene (Ref No 13630) SML = ND and 1 mg/kg in final product

Extraction Mean FDA Limit

Dual Use Food Additives:

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