October 25, 2016
John W. Boja, Ph.D.
Team Lead, Chemical Hazards
Views expressed in this presentation are those of the staff and do not necessarily represent the views of the Commission
Manufacturers and importers of products
requiring special packaging must certify in
a General Certificate of Conformity (GCC)
that their product(s) comply with the special
A manufacturer or importer must support
its GCC with records from a test of each
product or a reasonable testing program.
15 U.S.C. § 2063(a)(1)
The PPPA requires special packaging for
Special packaging must meet the performance
specifications of 16 C.F.R. § 1700.15.
Therefore, the importer or the domestic party
that packages any substance that requires
special packaging must certify that the special
packaging meets the performance
specifications of 16 C.F.R. § 1700.15.
1. Identification of the product
2. Citation to each CPSC product
safety regulation applicable
3. Identification of the U.S. importer
or domestic manufacturer
4. Contact information for the
individual maintaining records of
5. Date and place where the product
6. Date and place where the product
was tested for compliance with the
regulation(s) cited above
7. Identification of any laboratory on
whose testing the certificate depends
For complete instructions and more information see:
Describe the product(s) covered by the
certification in enough detail to match
the certificate to each product it
covers and no others.
Performance specification in
16 C.F.R. § 1700.15
Provide the name, full mailing address, and
telephone number of the importer or U.S.
domestic manufacturer certifying the
The importer must issue the GCC for
products manufactured overseas, and the
U.S. manufacturer must issue the GCC for
products manufactured domestically.
(See 16 C.F.R. part 1110)
Provide the name, full mailing address,
e-mail address, and telephone number
of the person maintaining test records in
support of the certification.
Date and place where the package was
filled, not the date and place where the
container was manufactured.
For the date(s) when the product was
filled, provide at least the month and
year. For the place of manufacture
provide at least the city and country
where the product was manufactured.
Provide the date(s) and place when the
packaging was tested for compliance
with the 16 C.F.R. § 1700.15.
Identification of the entity that
conducted the testing upon which the
Section 102 Certification and the Poison
Prevention Packaging Act
The importer or the domestic party that
packages a PPPA-regulated substance in
special packaging must issue the general
conformity certificate (GCC).
Protocol data obtained in accordance with the
procedures described under 16 C.F.R. §
1700.20 may be used by the importer or
domestic packager to support its
certification. The packager can rely upon this
data as the basis for the reasonable testing
Commission staff does not consider the
European tests (ISO 8317, EN 14375, and
EN862) to be the equivalent of the tests
required by the CPSC regulations.
There is no expiration date on these tests and no
requirement to retest so long as the tests
adequately reflect the current packaging used.
Retesting should be conducted when a material
change has been made to the packaging. A
material change is a change that the manufacturer
makes to the packaging's design, manufacturing
process, or to the source of component parts for
the packaging, which could affect the package's
ability to comply with the performance
specification of 16 C.F.R. § 1700.15.
No. The empty container is not subject to the
special packaging requirements of the PPPA
and does not require certification.
However, a packing manufacturer may certify
a package as having met the performance
specifications under 16 C.F.R. § 1700.15.
CPSC does not regulate children’s drugs and their
accompanying dosing devices such as dosing cups
or separate dosing droppers. These products are
excluded from the definition of "consumer product"
under the Consumer Product Safety Act. However,
the CPSC regulates the child-resistant packaging
for certain drugs as required by the Poison
Prevention Packaging Act (PPPA).
No. Bulk drugs provided to pharmacies are
not subject to the special packaging
requirements of the PPPA and therefore no
certificate is required.