Page 11 - Zochem Corporate Brochure
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Usp zinc oxide that Meets
the Highest standards
3. l series (L for Ultra-low Lead)
• Available in either USP or USP (API) registrations and
GMP
• Offers the lowest lead (Pb) level attainable, where
clients request impurity levels better than USP
monograph specification limits
• Meets FCC (Food Chemical Codex) model standards
• 10 PPM max lead
Zochem Grade 112 USPL or
112 USPL (API) Recommended
4. Fda approved • EU member states at EU 1-/2011 and EC 1935/2004
• Mercosur (South America) Positive List RD 39/19 Table 1
For all Zochem zinc oxide grades, “Product is USFDA • Japan JHOSPA and MHLW meets assay requirements
approved as GRAS (Generally Recognized as Safe) at 21 and impunity limits
CFR182.8991, meets GMP 21 CFR110, and authorized by
the FDA for use wherever GRAS is approved,” including: • China GB 9685-2016
• Rubber articles at 21 CFR177.2600(c)(1) Zochem Grade 102 (plastics), 500 (coatings),
• Plastics at 21 CFR177.1010(a) and 1010(b) (1) 400 (rubber) Recommended
• Food can liner and coatings at 21 CFR175.300(b)(2)
• Animal drugs, feeds, nutrient products and/or dietary
supplements at 21 CFR582
Other Country USFDA GRAS equivalent regulations and
approvals include:
• Canada (Zochem has received a no-objection letter from
Canada When quality matters
Pantone 569C