FDA Spec Encapsulants and Adhesives

Food Contact Applications For Silicone Rubber Compounds

Several Momentive Performance Materials RTV silicone rubber compounds can be evaluated for food contact applications where FDA, USDA and NSF regulations apply.

FDA Status

One-Part RTV Sealants

The following RTV silicone rubber adhesive sealants may be used in repeated contact with foods under FDA regulation 21CFR177.2600 “Rubber Articles Intended for Repeated Use” (and, by reference, 21CFR175.300 “Resins and Polymeric Coatings”).

RTV102 | RTV103 | RTV106 | RTV108 | RTV109 | RTV112 | RTV116 | RTV118 | IS802 | IS803 | IS806 | IS808

Use of these sealants is subject to the following conditions:

• The sealant must be applied in accordance with Good Manufacturing Practices at a thickness not to exceed 6mm (1/4″) from an exposed edge, as a continuous film between joints acting as a functional barrier between the food and the substrate (the area underneath the joint.)
• The sealant must be cured for a minimum of 14 days at 25C (77F) and 50% RH.
• The sealant must be thoroughly cleansed before the first use.
• The sealant, when properly cured, must comply with the extractives limitations at temperatures up to and including reflux applications. The user should verify compliance with extractives limitations at higher temperatures.
• Compliance with 21CFR177.2600 does not authorize use of these sealants for the manufacture of baby bottle nipples.

All previously mentioned sealants must be evaluated to determine bond strength for each specific application. If greater adhesion is required, the evaluation of primer SS4044 (clear) is recommended. SS4044 may be used in repeated contact with food under 21CFR175.105 “Adhesives”, and used in conjunction with the RTV products covered under 21CFR177.2600.

Two-Part RTV Sealants

The following two-component RTV silicone rubber compounds may be used in repeated contact with foods under FDA regulation 21CFR177.2600, “Rubber Articles Intended for Repeated Use”

RTV11 | RTV41 | RTV615 | RTV664 | RTF762 | LIM2500 | LIM2600 | LIM2700 | SLE5500 | SLE5600

Use of these compounds is subject to the following conditions:

• The compound must be applied in accordance with Good Manufacturing Practices.
• The compound must be thoroughly cleansed before the first use.
• Compliance with 21CFR177.2600 does not authorize use of the compound for the manufacture of baby bottle nipples.

RTV11 and RTV41 must be formulated with a catalyst which complies with 21CFR175.300 or 177.2600. These catalysts are Dibutyl Tin Dilaurate (DBT) and RTV9950. RTV11, RTV41 and SLE5500 compounds should not be used in contact with acid foods.

As with the sealants, primers may be desired. If so, the evaluation of primers SS4044 or SS4120 is recommended. These are covered under FDA regulation 21CFR175.105 “Adhesives”, and can be used in conjunction with the silicone compounds mentioned above covered under 21CFR177.2600.