Product Safety BasicsPresented by:

Susan DeRagon and Jennifer Buoniconti

UL

This information is being furnished by PPAI for educational and informational purposes only. The Association makes no warranties or

representations about specific dates, coverage or application.

Consult with appropriate legal counsel about the specific application of the law to your business and products.

Agenda

• Regulatory Landscape

• CPSIA Overview

• Best Practices by Category

US Regulatory Agencies

How many consumer products does CPSC regulate?

a) 1,500

b) 15,000

c) 150,000

International Agencies

2007: The Year of the Recall

Total of 448 product recalls

• 231, or 52%, were children’s products• Over 100 recalls due to excessive lead in paint

2007: Year of the Recall

• Increasingly end buyers and government agencies are demanding more from our industry• Social

• Environmental

• Product responsibility

Emerging challenges

• Compliance with Federal and state regulations is not optional

• It can be a strategic advantage and increase your value to your customer

We are in the brand protection business

Product responsibility is everyone’s job

• Distributors must protect their customer’s brand as if it were their own and do their own due diligence

• Suppliers must ensure compliance with all regulations and oversee all factories

• Everyone is responsible for providing safe products that will not cause harm to the end user

• Education and awareness are critical

When distributors become suppliers…

• A distributor who sources direct is a manufacturer

• A distributor who uses a contract decorator would also be considered a manufacturer

Consumer Product Safety Improvement Act of 2008

• Applies to all consumer products regulated by the CPSC

• Mandates certificates of compliance

• Enhances CPSC authority

CPSIA focus

• Defines a child as 12 and younger

• Applies to:

• Children’s products

• Childcare articles

• Children’s toys

CPSIA Factors to Consider

• A statement by a manufacturer about the intended use of such product, including a label on such product if such statement is reasonable.

• Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger.

• Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger.

• The Age Determination Guidelines issued by the Commission staff (http://www.cpsc.gov/BUSINFO/adg.pdf)

CPSIA requirements• Third party testing

mandatory:• Lead in substrate• Lead in paint and surface

coatings• Some phthalates

• Children’s Product Certificate mandatory

• Tracking labels mandatory

• Makes previously voluntary standards mandatory

Lead in substrate

Substrate is the material of which something is made, and to which surface coating (i.e. paint) may be applied

• 100 ppm lead as of August 14, 2011

Lead Paint Rule

Decorated or scrapable surface coatings

• 16 CFR 1303 in effect since 1978 at 600 ppm

• As of August 14, 2009, sets limit at 90 ppm

Phthalates

• Applies only to children’s toys and child care products

• For all such products, DEHP, DBP, BBP – limit of 0.1%• For all such products or any part of the product that

can be placed in a child’s mouth: DINP, DIDP, DnOP –limit of 0.1% (interim prohibition)

• Applies to accessible materials only (before and after use and abuse testing)

Mandatory Toy Safety Standard

• ASTM F963 has long been technically-voluntary industry standard

• Adopted by CPSC as mandatory CPSC safety standard

• ASTM F963-11 mandatory as of June 12, 2012• A few excepted sections

• ASTM committee will continue to update

• CPSC participates on ASTM committee

• ASTM F963-16 expected to become mandatory in April 2017

Children’s Product Certificate (CPC)

• Importer or Domestic manufacturer is responsible for testing and certification

• All testing must be reflected in Children’s Product Certificate (CPC) or General Conformity Certificate (GCC)

• Must be produced and made available for every youth order

• Sample certificates on the CPSC website

Children’s Product Certificate (CPC)

Tracking Labels

• Required for all children’s products manufactured after August 14, 2009

• Enhance recall effectiveness

• Required information: • Manufacturer name

• Month & year of manufacture

• City & state of manufacture

• Batch or internal order number

• Distributor PO number

Tracking Labels

• Must be permanent• Hangtags and adhesive labels not acceptable

• Supplier should include tracking label information

• Depending on changes made to the supplier’s product, distributor may need to include additional tracking label markings

Tracking Labels

Tracking Labels

• Example using the PPAI tracking label system:ps.ppa.org/SAMPLE003

Promotional Products Association International

Additional Promotional Product Requirements

• Apparel

• Houseware/drinkware

• Writing instruments

• Electronics

• Luggage/bags

• Health & Beauty products

Apparel - For the garment…

In general, exercise due care.

• Flammability of Wearing Apparel, 16 CFR 1610

• Fiber Identification Act

• Care Labeling Act

• Country of Origin

• RN number

Children’s Product?

• Size

• Imprint

• Children’s Product Certificate (CPC)

• Secondary tracking labels

• Drawstrings

Imprint/Decoration…• Ask yourself – are you now the manufacturer? Are you making a

material change to the product?• Imprints on children’s products

• CPSIA, Section 101 - Lead Paint Rule• Applicable if the ink can be scraped off the garment• 90ppm limit

• What about Bling / hard attachments? • Both lead limits apply to the decoration• Use and abuse testing for attachments is recommended (small parts, sharp

points, sharp edges)

• TESTING REQUIRED

Not just lead, phthalates too

But not for everything…for apparel, think apparel intended for ages three and under, sleepwear, baby blankets, sleep mats, bibs and more

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Phthalates may be found in decoration or attachments such as Velcro, vinyl, zippers, buttons, clasps, and rhinestones.

Secondary tracking label

When a distributor sources from an apparel distributor, contracts with a third-party decorator to apply ink or thread to a garment, and sells the product, the garment has been altered and requires a second tracking label for the same purpose as the first…

• A secondary tracking label is still required for embroidered items even though most embroidery threads are exempt from testing.

• Same type of information required as on primary tracking label:• Distributor’s (Decorator’s) name

• Month & year decoration was applied

• City & state where decoration was applied

• Decorator’s batch or internal order number

• Distributor’s contact information

Secondary tracking label best practices

Label location:

• Bottom hemline

• Inside back neck

• Sewn in as a label behind the original care/tracking label

• Can be incorporated into the decoration

• Additional Considerations• Seam strength/slippage

• Bursting/tensile strength

• Fabric construction/weight

• Pilling resistance

• Colorfastness of dyes

• Drawstrings are a Substantial Product Hazard!

Recall risk for apparel

• Failure to meet federal flammability standards

• Strangulation in case of drawstring around neck or waist area

• Small part detachment

• Lack of conformity with CPSIA

Houseware/Drinkware

• Federal Regulatory Requirements• Food & Drug Administration regulations

• 21 CFR – applicable extraction dependent on material

• FDA Guidelines 545.400 & 545.450 – ceramicware

• FDA ban on use of PC in infant bottles/spillproof cups

• GRAS – Generally Recognized As Safe (i.e. stainless steel)

• Additional Considerations• ASTM C927 – Lip & Rim• Massachusetts Total Immersion Test• California Tableware Safety Law• California Proposition 65

• Potential Concerns• Dishwasher / Microwave compatibility• Heat retention• Lid fit and leakage• Stain resistance• Breakage

Writing instruments

• In most cases, pens are considered general use…even if sold in school stores, back to school bins and include a school logo or mascot

Pens can become children’s products if…

• They have play value

• Licensing or theme has diminishing appeal to adults (mortification rule)

Due care still required…• LHAMA, ASTM D4236

• CPSC Guidance for extractable lead • Art materials (crayons, colored pencils, etc.)

• Lacey Act• Wood pencils

December 12, 1998 recall

Voluntary recall due to imprinted message.

• Additional Considerations• Crayons – ANSI Z356.1

• WIMA Voluntary Certification Programs

• Quality tests

• Potential Concerns• Children’s product requirements

• Lead content in surface coatings

Electronics

• Federal Regulatory Requirements• FCC requirements

• Mercury-containing Battery Management Act

Lithium battery issues

• Ingestion incidents are life-threatening

• Packaging requires special precautions

• Overheating and fire dangers lead to scores of recalls

• Fire risks lead to regulations for air transport

• Defects in manufacturing reveal QA challenge

• Replacement is not always foolproof

• End-of-life disposal creates safety and handling challenges

Why is it dangerous?

• Over voltage

• Over current

• Over temperature

• Internal forces

• External forces

Promotional Products and Recommended Testing/Certification

Type of Promotional Product Type of Test Work or Certification Services

Deliverable

Portable Battery Power (aka Power Bank / USB Battery Back-Up Charger)

UL 2054 test report only (may include UL/CSA 60950-1 requirements)

Not a certified product. Test report stored with battery mfr. and/or supplier.

UL 2054 certification for USA market UL in a Circle Certification Mark (USA only)

UL 2054+UL/CSA 60950-1 certification for USA/CAN market

UL in a Circle Certification Mark (USA/CAN)

IEC 62133 CB for international market CB Certificate (can be also test report only)

Wall Plug-In Charger and/or Adapter UL 1310 certification for USA market UL in a Circle Certification Mark (USA only)

UL 1310+CAN/CSA-C22.2 No. 223 certification for USA/CAN market

UL in a Circle Certification Mark (USA/CAN)

Bluetooth Audio/Video DeviceUL 60065 test report only

Not a certified product. Test report stored with mfr. and/or supplier.

UL 60065 certification for USA market UL in a Circle Certification Mark (USA only)

UL 60065 + CAN/CSA-C22.2 No. 60065certification for USA/CAN market

UL in a Circle Certification Mark (USA/CAN)

IEC 60065 CB for international market CB Certificate

Bluetooth Frequency Testing – FCC Part 15.247(USA)

Test Report

Bluetooth Frequency Testing - EN300-328(Europe)

Test Report

Bluetooth Frequency Testing - Other Bluetooth Standards

Test Report

Portable Vehicle Battery AdapterUL 2089 test report only

Not a certified product. Test report stored with mfr. and/or supplier.

UL 2089 for USA/CAN market UL in a Circle Certification Mark (USA only)

UL 2089 + CSA-C22.2 No. 107.2 certification for USA/CAN market

UL in a Circle Certification Mark (USA/CAN)

Laser PointersIEC 60825-1 test report only

Not a certified product. Test report stored with mfr. and/or supplier.

IEC 60825-1 certification for USA market (includes UL Follow-Up Services program)

UL in a Circle Certification Mark (USA/CAN)

IEC 60825-1 CB for international market CB Certificate

• Additional Issues include• Performance

• California Proposition 65

• Battery accessibility

• Children’s product safety

• Overheating

• What to do?• Tech products, particularly lithium ion batteries, are going to be an emerging

compliance challenge

• Don’t be overwhelmed – look for PPAI webinars

• Ask the right questions and demand testing documentation

Luggage / Bags

• Federal Regulatory Requirements• None!! …for adult items

• Unless intended to hold food (FDA)

• For children’s bags, standard CPSIA requirements apply

• Additional Considerations• Performance

• State restrictions

• Potential Concerns• Plastic bag suffocation warning

• Plastic sheet thickness

• Cords on bags

Health & Beauty Products

Regulated by the FDA

• Food, Drug and Cosmetics Act

Drugs may also be regulated by the CPSC

• Poison Prevention Packaging Act

Drugs

Drug is defined as a “product intended to treat or prevent disease, or affect the structure or function of the body.”

Examples:

• Sunscreen

• Dandruff Shampoo

• Acne treatment

• Antiperspirants

• Anything that makes a claim to treat or prevent

Cosmetics

Cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing beautifying, promoting attractiveness, or altering the appearance.”

Doesn’t claim to treat or prevent anything.

Examples:• Moisturizers• Perfumes• Lipstick• Fingernail polish• Cleansing shampoos• Hair colors

How do I tell the difference?

• Drugs make claims. Cosmetics do not.

» Balm is a claim. Moisturizer is not.

• It is possible to be both a drug and a cosmetic.

• Proper labeling is imperative for FDA compliance.

• Consistency in Principle Display Panel (PDP) Requirements» Statement of Identity

» Weight

Cosmetic label sample

OTC drug label sample

Remember…

Regardless of the size of the container, it must be labeled properly. If you have a lip moisturizer, in a lip balm tube, making an SPF claim-it must be labeled as an OTC. So, you have to put all of the information on the sunscreen bottle on the label of that lip balm tube.

CPSC recall June 11, 2015

Hazard: The packaging is not child-resistant and senior friendly as required by the Poison Prevention Packaging Act.

Recall October 15, 2012

Hazard: Hand sanitizer recalled due to microbial contamination.

Product responsibility

Also has resources for Social Responsibility and Environmental Responsibility

•Most pens are general use•Think before you include a picture of a child interacting with the item on your website or in your advertising•Look for tracking labels—no one size fits all solution•Test reports should include pictures•If it is a children’s product, ask for the CPC•No drawstrings!•Ask your screenprinter for ink test reports•Look for the secondary tracking label•Even if the item is a general use item, there may be regulations beyond CPSIA

1627 Letters of Advice (LOA) for violation of a mandatory standard in last 12 months

• 552 tracking label violation

• 412 lead in children’s product

• 136 small parts violations

• 94 third party certificate violation

• 50 sleepwear labeling or flammability failure

• 44 lead in paint violation

• 39 bicycle helmet labeling

• 39 bicycle helmet labeling

• 33 art materials labeling

• 30 mislabeled items

• 20 exceeds phthalate ban limit

• 13 ASTM toy standard violation

Product Responsibility Resources

PPAI: www.ppai.org

Product Safety powered by PPAI: http://www.ppai.org/inside-ppai/corporate-responsibility/

Consumer Product Safety Commission: www.cpsc.gov; www.recalls.gov

UL: www.ul.com

Questions? AnneS@ppai.org 972-258-3041