Small Entity Compliance Guide: Establishing an Allowable Level for di (2-ethylhexyl)phthalate in Bottled Water

Description

On October 19, 2011, the Food and Drug Administration (FDA) published a final rule in the Federal Register (76 FR 64810) that amended its bottled water standard of quality regulations by establishing an allowable level for di(2-ethylhexylphthalate) (DEHP).  The final rule is effective on April 16, 2012.  As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for DEHP as often as necessary, but at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water.  Bottled water manufacturers also are required to monitor for DEHP at least once each year in their source water, unless the bottlers meet the criteria for source water testing exemptions under the CGMP regulations.

Key Topics

Terms and concepts identified from this document

• 21CFR165.110§ 165.110 Bottled water.

  (a) Identity —Read full regulation →

Deficiencies cited in Warning Letters referencing the same regulations

• Processing & Bottling of Bottled Drinking Water Regulations/Adulterated

  Longford Water Company LLC

  2025-12-16

• CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated

  Waiakea Bottling Inc.

  2024-09-03

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