GUIDANCE FOR INDUSTRY
Submitting Requests
Under 21 CFR 170.39
Threshold of Regulation For Substances Used in Food-Contact Articles
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 Julius Smith at FDA's Office of Food Additive Safety
(301) 436-1245 or julius.smith@fda.hhs.gov. Additional copies of this guidance
are available at http://www.cfsan.fda.gov/~dms/guidance.html.
For questions regarding the use or interpretation of this guidance, or to obtain
printed copies of this document, contact the Office of Food Additive Safety
at premarkt@cfsan.fda.gov
Introduction
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.
Listed below is guidance for submitting a request to FDA for consideration
under the threshold of regulation process established by 21 CFR 170.39 (Final
rule published on July 17, 1995; 60 FR 36582). Requests should be limited to
only those substances used in food-packaging or food processing equipment that
are not designed to have a technical effect on the food itself.
Procedures
Four copies of the request should be submitted. The request should contain
the following information:
- The chemical composition of the substance for which the request is made,including,whenever
possible, the name of the chemical in accordance with current Chemical Abstract
Service (CAS) http://info.cas.org/
nomenclature guidelines and a CAS Registry Number, if available[1];
- The intended technical effect of the substance in the food-contact article
(e.g., stabilizer, catalyst, defoamer);
- Detailed information on the conditions of use of the substance (e.g., temperature,
type of food with which the substance will come into contact, the duration
of the contact, and whether the food-contact article will be for repeated
or single use applications);
- A clear statement as to whether the request for exemption from regulation
as a food additive is based on the fact that the use of the substance in the
food-contact article results in a dietary concentration at or below 0.5 ppb,
or on the fact that it involves the use of a regulated direct food additive
for which the dietary exposure is at or below 1 percent of the acceptable
dietary intake (ADI);
- Data that will enable FDA to estimate the daily dietary concentration resulting
from the proposed use of the substance, except in those cases where FDA has
historically not requested such data. (For example, FDA has not asked for
such data when the substance is an alloy that is resistant to corrosion and
abrasion. Instead, the agency has requested information on the properties
of the alloy (e.g., hardness) that enable it to resist corrosion and abrasion.
However, if the alloy is relatively soft, or contains active metals, or there
is reason to suspect the presence of heavy metal contaminants (e.g., Pb, Cd,
and Hg), the requestor should consult FDA for specific advice on the types
of information that will be required.)
- These data should be either in the form of:
- Validated migration data obtained under worst-case (time/temperature)
intended use conditions utilizing appropriate food simulating
solvents as discussed in "Recommendations
for Chemistry Data for Indirect Food Additive Petitions"
or
- Level of the substance used in the manufacture of the food contact
article or the residual level of the substance present in the
finished food-contact article. These data should be used to estimate
a worst-case dietary concentration level assuming 100% migration
to food. The agency recognizes that there may be cases in which
mitigating circumstances make it highly unlikely that all of the
substance would migrate to food. In such cases, submissions should
include a detailed discussion of any factors that are likely to
significantly decrease the extent of migration of the substance
to food.
- The submission should also include a detailed description
of the analytical method used to quantify the substance along with
data used to validate the method. In cases where there is no detectable
migration into food or food simulants, or when no residual level of
a substance is detected in the food-contact article by a suitable
analytical method, the validated detection limit of the method used
to analyze for the substance should be considered in estimating the
dietary concentration. Submissions, in such cases, should include
the data used to validate the method's detection limit.
- For repeat-use articles, the submission should include
an estimate of the amount of food that contacts a specific unit of
surface area over the lifetime of the article.
- A detailed discussion of how to estimate the dietary
concentration resulting from the intended use of a substance in a
food-contact article can be found in "Recommendations
for Chemistry Data for Indirect Food Additive Petitions".
Interested persons are also encouraged to obtain specific guidance
from FDA's Office of Food Additive Safety (HFS-200), 5100 Paint Branch
Parkway, College Park, MD 20744) on the appropriate protocols to be
used for obtaining migration data, on the validation of the analytical
methods used to quantify migration levels, on the procedures used
to relate migration data to dietary exposures, and on any other issue
not specifically covered in these guidelines, (see Exemptions for
Houseware Articles)
- The results of a literature search of existing toxicological information
on the substance and its impurities. This information is needed to determine
whether an animal carcinogen bioassay has been carried out, or whether there
is some other basis for suspecting that the substance is a carcinogen or potent
toxin. This information on the impurities is needed to determine whether
any of them are carcinogenic and, if carcinogenic, whether their TD50
values are greater than 6.25 mg/kg bodyweight per day, in accordance with
§ 170.39(a)(1).
- TOR submissions are agency actions that are subject to NEPA. Therefore,
a TOR submission must contain either a claim of categorical exclusion, as
specified under 21 CFR 25.15, or an environmental assessment (EA) as
specified under 21 CFR 25.15 and 40.
- Claims of categorical exclusions that may apply to TOR submissions
are 21 CFR 25.32(i), (j), or (q).
- To qualify for an exclusion under 21 CFR 25.32(i), the substance
must be present in the finished food-contact article at not greater
that 5 percent-by-weight and must be expected to remain with the finished
food-contact article through use by consumers or when the substance
is a component of a coating of a finished food-packaging material
- To qualify for an exclusion exemption under 21 CFR 25.32(j), the
substance must be used as a component of a food-contact surface of
permanent or semipermanent equipment or of another food-contact article
intended for repeated use.
- To qualify for an exclusion under 21 CFR 25.32(q), the substance
must be registered by the Environmental Protection Agency under FIFRA
for the same use as requested in the request for exemption.
- An adequate claim of categorical exclusion submitted under 21 CFR
25.15 should:
- Cite the section of the CFR under which the categorical
exclusion is claimed,
- Include a statement of compliance with the categorical exclusion
criteria, and
- Include a statement that, to the submitter’s knowledge,
no extraordinary circumstances exist that require the submission
of an EA.
- If the TOR submission does not qualify for categorical exclusion, then
it must contain an EA. The EA should include information that will
enable FDA to determine whether to prepare a finding of no significant
impact or an environmental impact statement.
Guidance on how to prepare a claim of categorical exclusion or an environmental
assessment is found at http://www.cfsan.fda.gov/~dms/opa-eg.html.
You can also find examples of extraordinary circumstances on that site.
In the past, FDA typically has not required food additive petitions containing
the data described in item 5 above for food-contact articles used exclusively
in the home or in restaurants. Although components of houseware articles that
are reasonably expected to become components of food are food additives subject
to premarket approval, in most cases, the use of such articles results in trivial
levels of migration to food either because of short contact times or because
the articles are manufactured using materials (e.g., alloys and ceramics) that
pose little likelihood of migration to food. Therefore, the agency, because
of limited resources, has not enforced the food additive provisions of the FD&C
Act for such cases unless there is evidence of a potential health hazard. However,
FDA cannot issue a binding "exemption from regulation" under 21 CFR
170.39 for houseware articles in the absence of information to show that the
use of such articles would result in, or would reasonably be expected to result
in, dietary concentrations below the "threshold". FDA is particularly
concerned with single-service houseware articles that contain components that
have the potential for migrating to food in significant amounts (i.e., would
result in dietary concentrations above the threshold of regulatory concern).
Therefore, the data described in item 5 above will also be required for any
submission requesting an exemption for the use of a substance in a single-service
houseware article. For repeat-use articles, the submission may need to include
an estimate of the amount of food that contacts a specific unit of surface area
over the lifetime of the article. The requestor should consult FDA as to whether
such data will be needed for a specific repeat-use houseware article.
Endnotes
[1] If the chemical
formulation that is the subject of the exemption request involves a chemical(s)
that is purchased from a manufacturer that considers its identity as trade secret,
the requestor will need to contact the supplier(s) and have them send the applicable
identity information (compositional information if this chemical is itself part
of a chemical formulation) directly to FDA. If FDA determines that one or more
components of the supplier's formulation is not regulated for the intended conditions
of use, FDA will contact that supplier(s) and inform him of that fact. FDA
would also inform the supplier that if the request qualifies for an exemption
under 21 CFR 170.39, the identity of those chemical(s) that are the subject
of the exemption (as well as appropriate limitations (e.g., use level)) would
be put on public display at FDA's Docket Management Branch. (It would be emphasized
that the identity of only those chemicals that are the subject of the exemption
would be made publicly available. The remaining chemicals and composition of
the formulation (i.e., weight percent of each chemical) would not be released
to the public.) For FDA to proceed with its review of the exemption request,
the supplier would need to agree that this identity information could be released
in the event that these substances qualified for an exemption. If this potential
release of information is acceptable, the supplier working in conjunction with
the requestor would need to provide all of the information on these substances
needed by FDA to complete its review.
If the supplier does not agree that the identity of the substance(s) can be
released in the event that an exemption is issued by FDA, the requestor would
be informed by FDA that this part of the request cannot be processed and the
applicable chemical(s) would have to be either be eliminated from the formulation
or replaced with chemicals that meet the regulations for the intended conditions
of use or can be purchased from suppliers who do not regard their identities
as trade secret.
This document updates and supercedes the 1996 version of the Guidance for Submitting
Requests Under 21 CFR 170.39 Threshold of Regulation for Substances Used
in Food-Contact Articles.