Contains Nonbinding Recommendations 
Guidance for Industry 
Bottled Water Quality Standard:  
Establishing an Allowable Level for  
di(2-ethylhexyl)phthalate 
Small Entity Compliance Guide 
Additional copies are available from: 
Office of Food Safety 
Division of Plant and Dairy Food Safety, HFS-317 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
(Tel) 240-402-1700 
http://www.fda.gov/FoodGuidances 
You may submit either electronic or written comments regarding this guidance at any time.  
Submit electronic comments to http://www.regulations.gov.  Submit written comments on the 
guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
April 2012  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
I.     Introduction 
  
II.   Background
 
   
III. Questions and Answers
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  2 Contains Nonbinding Recommendations 
Guidance for Industry1
 
Bottled Water Quality Standard:  Establishing an Allowable Level for 
di(2-ethylhexyl)phthalate 
Small Entity Compliance Guide 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance.  
 
 
 
I.  Introduction 
 
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.   
 
FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).  This guidance 
document restates in plain language the legal requirements set forth in 21 CFR part 129 and part 
165 concerning the contaminant DEHP.  These regulations are binding and have the full force 
and effect of law. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
                                                 
1 This guidance has been prepared by the Division of Plant and Dairy Food Safety, Office of Food Safety, in the 
Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
 
  3 Contains Nonbinding Recommendations 
II.  Background 
 
In the Federal Register of August 4, 1993 (58 FR 41612), FDA published a proposal to revise the 
bottled water standard of quality regulations in 21 CFR part 103 (now 21 CFR 165.110(b)) to 
establish or modify the allowable levels in bottled water for 5 inorganic chemicals and 18 
synthetic organic chemicals, and to maintain the existing allowable level for the inorganic 
chemical sulfate.  As required under Section 410 of the Federal Food, Drug, and Cosmetic Act, 
FDA proposed these revisions in response to the publication by the Environmental Protection 
Agency (EPA) of a final rule (57 FR 31776; July 17, 1992) that established national primary 
drinking water regulations consisting of maximum contaminant levels (MCLs) for the same 23 
chemicals and establishing an MCL for sulfate in public drinking water under the Safe Drinking 
Water Act.  In a final rule published March 26, 1996 (61 FR 13258), FDA maintained its existing 
allowable level for sulfate and adopted the proposed allowable levels for the 5 inorganic 
chemicals and 17 of the synthetic organic chemicals.  FDA deferred final action on the proposed 
allowable level of 0.006 milligrams/liter (mg/L) for the chemical DEHP in response to a 
comment. 
 
In the Federal Register of April 1, 2010 (75 FR 16363), FDA reopened the comment period for 
the 1993 proposed rule to seek further comment on finalizing the allowable level for DEHP in 
the bottled water quality standard.  In response to new information and comments received, FDA 
published the October 19, 2011 final rule.  This final rule ensures that FDAs standards for the 
minimum quality of bottled water, as affected by DEHP, will be no less protective of the public 
health than those set by EPA for public drinking water. 
 
III.  Questions and Answers    
 
1. What is the allowable level established by FDA for DEHP in bottled water? 
 
The allowable level established by FDA for DEHP in bottled water is 0.006 milligram per 
liter (mg/l) (21 CFR 165.110(b)(4)(iii)(C)). 
 
2. What analytical methods are used for determining compliance with the allowable level for 
DEHP in bottled water? 
 
The analytical methods used for determining compliance with the allowable level for DEHP 
in bottled water are as follows: 
 
  Method 506, Rev. 1.1Determination of phthalate and adipate esters in drinking 
water by liquid/liquid extraction or liquid/solid extraction and gas chromatography 
with photoionization detection, U.S. EPA, 1995, EPA/600/R95/131 (21 CFR 
165.110(b)(4)(iii)(F)(21)), and 
 
  Method 525.2, Rev. 2.0Determination of organic compounds in drinking water by 
liquid-solid extraction and capillary column gas chromatography/mass spectrometry, 
U.S. EPA, 1995, EPA/600/R95/131 (21 CFR 165.110(b)(4)(iii)(F)(22)). 
  4 Contains Nonbinding Recommendations 
 
3. Where can I find the analytical methods? 
 
The analytical methods can be found in the following sources: 
 
  EPA Method 506, Rev. 1.1, can be found in Methods for the Determination of 
Organic Compounds in Drinking Water, Supplement III, EPA National Exposure 
Research Laboratory, EPA/600/R95/131, August 1995, which can be accessed 
online at http://www.epa.gov/nscep/index.html. 
 
  EPA Method 525.2, Rev. 2.0, can be found in Methods for the Determination of 
Organic Compounds in Drinking Water, Supplement III, EPA National Exposure 
Research Laboratory, EPA/600/R95/131, August 1995, which can be accessed 
online at http://www.epa.gov/nscep/index.html. 
 
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