Today, companies which manufacture and sell basic and luxury foodstuffs or pharmaceutical products internationally must ensure that their manufacturing processes comply with the requirements of the American Food and Drug Administration, as laid down in the Directive 21 CFR Part 11.

The FDA is concerned primarily with the protection of consumer health in the USA, but the FDA Directives are being used increasingly in Germany and Europe for the assessment of the suitability of technical products for use in the foodstuffs sector.

The requirements, which are frequently referred to as the "FDA Directive" also apply to suction pads used, for example, for handling foodstuffs and the containers in which they are packed.

 
The suction-pad material SI (silicone) used in Schmalz suction pads possesses this FDA conformity.

In other words, the chemical composition of the elastomer mixture used for the manufacture of the following articles complies with:

• the requirements of the BGVV Recommendation No. XV and
• the positive list shown in CFR 21 § 177.2600 from the FDA.

Article group	Article designation	Material and Shore hardness
PFG	Flat suction pad (round), without nipple	Silicone, 55 Shore
SGO	Flat suction pad (oval), without nipple	Silicone, 55 Shore
FGA	Bellows suction pad (round, 1.5 corrugations), without nipple	Silicone, 55 Shore
FG	Bellows suction pad (round, 2.5 corrugations), without nipple	Silicone, 55 Shore