December 2015 Regulatory Update

  1. FEDERAL NEWS
  2. USA STATE NEWS
  3. INTERNATIONAL NEWS – NORTH AMERICA
  4. INTERNATIONAL NEWS – SOUTH AMERICA
  5. INTERNATIONAL NEWS – EUROPE
  6. INTERNATIONAL NEWS – ASIA

USA FEDERAL NEWS

The Federal Trade Commission (FTC) amends the rules under Fair Packaging and Labelling Act (FPLA)

In February 2015 the FTC requested comments on proposed changes to the FPLA and, after reviewing the comments, the following changes were finalized:

  • Modernized the place of business listing requirement to incorporate online resources. (Allows a street address to be omitted if it is listed in any readily accessible, well-known, widely published and publicly available resource such as printed directory, electronic database, or website.)
  • Incorporated a more comprehensive metric chart. (Deleted current chart and incorporated by reference the metric conversion chart in NIST handbook 133-2015.)
  • Addresses the use of exponents with customary inch/pound measurements.
  • Deleted outdated prohibitions on retail price sale representations. (Eliminates the terms “cents off”, “introductory offer”, and “economy size”.)
International Association of Bedding and Furniture Officials (IABFLO) Updates the Guidance Document for Uniform Law Labels for Bedding and Furniture

Certain states require a label that will provide information about the filling materials used in bedding and furniture products. The IABFLO has updated their guidance document for Uniform Law Labels for Bedding and Furniture. The updates include the following:

  • The requirement for “Date of Delivery___” has been eliminated but can still be used
  • Requires a minimum font size of 1/8” for all sections of the law label
  • The section “ALL NEW MATERIAL” must be in capital letters and the whole section in bold print
  • The description used to describe the fillings must be in capital letters and bold print
  • The section “UNDER PENALTY OF LAW” must be in capital letters and bold print
  • The words “consisting of” can be in lower case but must be in bold print
  • The 3” length requirement of the law label starts from the beginning of the word “UNDER” and ends at the Country of Origin at the bottom of the label
  • The lines separating text must extend to the edges of the law label
CPSC Proposes Direct Final Rule to Clarify Component Part Testing and Lead in Textiles - Delay of Effective Date and Extension of Comment Period

The Consumer Product Safety Commission (CPSC) proposed a direct final rule to clarify when component part testing can be used and which textile products have been determined not to exceed the allowable lead content limits under the Consumer Product Safety Improvement Act (CPSIA).

The effective date for the direct final rule published October 14, 2015 at 80 FR 61729 is delayed from December 14, 2015, until January 13, 2016 and the comment period is extended to December 14, 2015. The rule will be effective unless the CPSC receives significant adverse comments after which time they would publish notification in the Federal Register withdrawing this direct final rule before its effective date.

Summary of Amendments:

16 CFR 1109, Clarification of the Component Part Rule

Subpart A of 16 CFR 1109 provides the general requirements for component part testing, and subparts B and C provide for additional conditions for specific products and requirements. The amendment clarifies that component part testing can be used for products or requirements other than those explicitly specified in 16 CFR 1109 Subpart B (lead, heavy metal and phthalates content in paint and substrate) and Subpart C (composite testing).

The amendment also brings two other provisions of the component part rule up to date.

Updates the Toy standard reference to ASTM F963-11 from ASTM F963-08 in section 1109.11 (a).

Section 1109.13 addresses when a certifier may rely on component part testing for phthalates in children's toys and child care articles. The amendment adds a reference to the Commission's guidance concerning inaccessible component parts (16 CFR part 1199). This change will make the provision concerning phthalates (section 1109.13) consistent with the provision concerning lead (section 1109.12) and will help certifiers understand which components are inaccessible and do not need to be tested for phthalate content.

16 CFR 1500.91, Clarification of the Textile Lead Determination

CPSIA Section 101(a) provides that products designed or intended primarily for children ages 12 and younger may not contain more than 100 ppm of lead. A determination by the CPSC in 16 CFR 1500.91 that a material or product does not contain a lead level that exceeds 100 ppm relieves the material or product from the third party testing requirement.

Section 1500.91(d)(7) states that such a determination (exemption) applies to “textiles (excluding after-treatment applications, including screen prints, transfers, decals, or other prints) consisting of [various fibers].” Thus, the rule determined that dyes and dyed textiles do not contain lead. This rule clarifies that “other prints” referred only to those after-treatment applications that use non-dye substances, in which the non-dye substances do not become part of the fiber matrix but remain a surface coating, could contain lead, and are subject to the testing required under the CPSIA for children's products.

To read more, click here.

Significant New Use Rule for Hexabromocyclododecane and 1,2,5,6,9,10-Hexabromocyclododecane

The U.S. Environmental Protection Agency (EPA) promulgated a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for two chemical substances collectively referred to as ‘‘HBCD’’ subject to reporting, which are identified as (1) hexabromocyclododecane (CASRN 25637-99-4) and (2) 1,2,5,6,9,10-hexabromocyclododecane (CASRN 3194-55-6). The significant new use is for consumer textiles, other than for use in motor vehicles.

The final rule, 40 CFR 721, came into force on November 23, 2015.

To read more, click here.

FDA Issues Draft Guidance on EMC of Electrically-Powered Medical Devices

On November 2, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document entitled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.” This document describes the types of information that should be provided to support a claim of electromagnetic compatibility (EMC) in a premarket submission for an electrically powered medical device. For the purpose of this document, EMC is defined as the ability of a device to function (a) properly in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference), and (b) without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.

According to this guidance document, a claim of EMC for a device should be accompanied by the information listed below:

  • Summary of the testing that was performed to support EMC
  • The specifications of the standard that were met (including immunity test levels)
  • The device-specific pass/fail criteria used
  • The specific functions of the device that were tested (e.g. for IEC 60601-1-2, including essential performance) and how these functions were monitored
  • The performance of the device during each test, indicating if the device met the emissions and immunity pass/fail criteria
  • An identification of and a justification for any of the standard’s allowances that were used
  • A description of and justification for any deviations from the specifications of the referenced standard
  • The device labelling and evidence of compliance with the reference standard’s labelling specifications
  • A detailed description of all changes or modifications that were made to the device in order to pass any of the EMC tests

FDA welcomes comments and suggestions on this draft through mid-December.

This draft guidance is not final nor is it in effect at this time.

To read more, click here.

CPSC Opens Comment Period on Proposed Extensions of Collection of Information

The Consumer Product Safety Commission (CPSC) is looking to renew the recordkeeping requirements (Collection of Information) for the regulations listed below. As required by the Paperwork Reduction Act, the CPSC must request comments in regards to the proposed extensions of the collection of information. The CPSC is specifically looking for feedback relevant to the following topics:

  • Whether the collection of information is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility
  • Whether the CPSC estimated burden of the proposed collection of information is accurate
  • Whether the quality, utility, and clarity of the information to be collected could be enhanced
  • Whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology
Regulations:
  • Electrically Operated Toys and Children’s Articles (16 CFR Part 1505) The current collection of information requirements are: Manufacturers and importers of electrically operated toys and children's articles are required to maintain records for three years on: (1) Material and production specifications; (2) the quality assurance program used; (3) results of all tests and inspections conducted; and (4) sales and distribution of electrically operated toys and children's articles. Comments can be provided until January 25, 2016.
  • Baby-Bouncers, Walker-Jumpers, and Baby Walkers The current collection of information requirements are: Among other requirements, the regulations require manufacturers, including importers, to meet the collection of information requirements for labelling and recordkeeping requirements. Comments can be provided until December 28, 2015.
  • Recordkeeping Requirement under safety standard for Infant Swings The current collection of information requirements are: Among other requirements, the standard requires manufacturers, including importers, to meet the collection of information requirements for marking and labelling for infant swings. Comments can be provided until December 7, 2015.
  • Third Party Testing of Children’s Products The current collection of information requirements are: Records required by the testing rule and the rule on selecting representative samples appear in 16 CFR 1107.26. Required records include a certificate, and records documenting third party testing and related sampling plans. These requirements largely overlap the recordkeeping requirements in the component part rule, codified at 16 CFR 1109.5(g). Duplicate recordkeeping is not required; records need to be created and maintained only once to meet the applicable recordkeeping requirements. The component part rule also requires records that enable tracing a product or component back to the entity that had a product tested for compliance, and also requires attestations of due care to ensure test result integrity. Comments can be provided until January 15, 2016.
  • Flammability Standards for Children's Sleepwear, sizes 0-6X (16 CFR 1615) and sizes 7-14 (16 CFR 1616) The current collection of information requirements are: The standards require manufacturers and importers of children's sleepwear to collect information resulting from product testing, and maintenance of the testing records. 16 CFR part 1615, subpart B; 16 CFR part 1616; subpart B. Comments can be provided until January 25, 2016.
CPSC Proposed Rules

The Consumer Product Safety Commission (CPSC), as required under the Danny Keysar Child Product Safety Notification Act, Section 104 of CPSIA, has issued proposed safety standards for the following durable infant and toddler products. All manufacturers will be subject to third party testing and certification requirements. The rules will become effective six months after publication in the Federal Register for products manufactured or imported on or after that date.

  • 16 CFR Part 1234 Infant Bath Tubs The proposed rule is based on the voluntary standard ASTM F2670-13 with several modifications to some of the warnings and instructions. Comments were received up to October 28, 2015.
  • 16 CFR Part 1232 Children’s Folding Chairs and Stools The rule would incorporate by reference the voluntary standard ASTM F2613-14 with several modifications such as:
    • Limit the scope of the mandatory standard to Children’s Folding Chairs and Folding Stools only
    • Change the stability test method to add a test method to address sideways and rearwards stability
    • Revise the marking and labelling sections
    Comments can be sent until January 4, 2016.
  • 16 CFR Part 1229 Infant Bouncer Seats The rule would incorporate by reference the voluntary standard ASTM F2167-15 with several modifications to the text, placement and formatting of warning requirements and instructional literature requirements. Comments can be sent until January 4, 2016.
  • 16 CFR Part 1231 High Chairs The rule would incorporate by reference the voluntary standard ASTM F404-15 with several modifications such as:
    • More stringent standard for rearwards stability
    • For warning labels on the product there are additional content, form, and placement provisions
    • Provides additional guidance by referencing ANSI Z535.4
    Comments can be sent until January 25, 2016.
PROFECO Hosts Third North America Consumer Product Safety Summit

Mexico’s Consumer Protection Federal Agency (PROFECO) hosted the third North America Consumer Product Safety Summit in Mexico City on November 18 and 19. PROFECO was joined by the Consumer Product Safety Commission (CPSC) and Health Canada, representing product safety interests in the United States and Canada respectively. The Summit provides an opportunity for the three national consumer product safety regulators to evaluate their progress under the North America Cooperative Engagement Framework (CEF), a mechanism established during the first North America Summit to enhance collaboration on consumer product safety.

Since the last Summit in 2013, the cooperative efforts of the three government product safety organizations have resulted in:

  • The establishment of Joint Project Teams to address various concerns including inter-laboratory test methods, customs collaboration and joint outreach campaigns and events.
  • Conducting seven trilateral recalls
  • Consultation and alignment on product hazards before regulatory and standards development activities
  • Increased flow of shared information, particularly in the area of import surveillance

During the Summit, several additional areas of focus were identified to further enhance the cooperative efforts among the regulators including:

  • Further development of cross-border cooperation to prevent trade of hazardous products within North America
  • Improved notification regarding hazard reporting when product is distributed in two or more North American countries
  • Developing procedures to share information pertaining to e-commerce vendors and suppliers of products that may pose a safety threat to North American consumers
  • Developing a trilateral Memorandum of Understanding to sustain and elevate cooperation relative to consumer product safety in North America

The regulators from the three jurisdictions will continue to work together to further the objectives under the CEF and have scheduled the next Summit for 2018.

Updates of ASTM Standards

Below is a summary of recently updated ASTM standards

CPSIA / CFR Reference ASTM Standard No. ASTM Standard
16 CFR Part 1231 (Proposed Rule) ASTM F404-15 Standard Consumer Safety Specification for High Chairs Covers the performance requirements and methods of test to ensure the satisfactory performance of the high chair and high chairs created by using a high chair conversion kit and component(s) from another product.
Durable Nursery Goods with no CPSIA rule yet ASTM F1004 - 15a Standard Consumer Safety Specification for Expansion Gates and Expandable Enclosures Covers minimum safety performance requirements, test methods, and requirements for labelling and instructional material to minimize hazards to young children resulting from the normal use and reasonably foreseeable misuse and abuse of expansion gates and expandable enclosures.
16 CFR Part 1223 ASTM F2088 - 15 Standard Consumer Safety Specification for Infant Swings Covers safety performance requirements, test methods, and labelling requirements to minimize the hazards to infants presented by swings.
16 CFR Part 1229 (Proposed Rule) ASTM F2167-15 Standard Consumer Safety Specification for Infant Bouncer Seats Covers the establishment of requirements, test methods, and marking requirements to promote safe use of infant bouncer seats.
Durable Nursery Goods with no CPSIA rule yet ASTM F2907 - 15 Standard Consumer Safety Specification for Sling Carriers Covers performance requirements, test methods and marking requirements to promote safe use of sling carriers.

USA STATE NEWS

New York Counties Stay Bans on Toxic Chemicals in Children’s Products

Rockland and Albany Counties in New York State have agreed to postpone the enforcement of their Toxic Free Toys Acts (TFTA) until 2016. The stays will give both counties time to develop and implement their regulations in line with existing federal laws. Albany County has already been challenged with litigation in part due to the fact that their TFTA includes chemical restrictions that pre-empt federal law. Rockland County has agreed to a stay to avoid similar litigation. Both Suffolk and Westchester Counties in New York have similar TFTAs scheduled to go into effect during 2016.

For retailers, distributors, and manufacturers of products intended for children age 12 and younger, the TFTAs present new compliance challenges as they set limits and/or bans for chemicals of concern, with certain exclusions, that are more restrictive than current federal requirements for these products. Additionally, the pending 2016 enforcement dates coupled with the uncertainty of how the final, enforceable laws will be written, leaves companies with many questions as to how they can reasonably ensure their products will be compliant by the enforcement dates. Additionally, the possibility remains that any or all of these laws may never go fully into effect or may be further pre-empted by pending children’s product laws at the New York State level. A summary of the current County TFTAs may be found in the table below:

County Enforcement Status Chemicals of Concern Penalties
Albany Enforcement date is 1/12/2016 however County has agreed to stay enforcement  until 6 months after pending lawsuit is resolved Lead, Cadmium, Mercury, Antimony, Arsenic, Cobalt and Benzene are banned $500 for 1st violation.
$1000 for each subsequent violation. Each Violation shall constitute a separate offense.
Rockland Enforcement date was 10/12/2015 however County has agreed not to enforce until 1/1/2016 Lead, Cadmium, Mercury, Antimony, Arsenic, Cobalt and Benzene are banned $500 for 1st violation.
$1000 for each subsequent violation. Each Violation shall constitute a separate offense.
No penalties shall be imposed until County has made make a good-faith effort to issue a warning and educate the alleged violator.
Suffolk Retailers notified beginning January 2016 and must not knowingly sell product in violation beginning July 2016. Random inspections of retailers beginning December 2016 including on-site testing with an XRF analyzer. Total content limits established for Lead, Cadmium, Mercury, Antimony, Arsenic, and Cobalt $500 for 1st violation,
$1000 for each subsequent violation, subject to hearing. Additionally County is authorized to order removal of all stock in violation.
Westchester 5/14/2016 Lead, Cadmium, Mercury, Antimony, Arsenic, Cobalt, Benzene and Formaldehyde are banned Violations shall be in accordance with provisions of Chapter 182 and Chapter 277 Article VIII
Texas Removes Bedding Law Requirements

Texas Senate Bill 202 became effective on September 1, 2015 stating that the Department of State Health Services (DSHS) will no longer issue or renew any Bedding law licenses. Manufacturers that were using a Texas Uniform Registry Number (URN) as their registration number will need to obtain a URN from a different state.

California Proposition 65 Updates:

OEHHA Notice of Intent

The Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice of intent (NOI) to list Pentachlorophenol (CAS #87-86-5) which includes Pentachlorophenol, sodium salt as a Proposition 65 carcinogen.

OEHHA Proposed Rulemaking - Lead

The Office of Environmental Health Hazard Assessment (OEHHA) has initiated rulemaking to update the existing Maximum Allowable Dose Levels (MADL) for exposure to Lead as a reproductive toxicant. This action is in response to a petition by the Center for Environmental Health (CEH).

The current MADL for Lead is 0.5 micrograms per day, which was established in 1989. The proposed MADL for Lead in this pre-regulatory draft proposal is based on the frequency and the length of exposure:

0.2 micrograms every day, or 0.3 micrograms one day in every 2 days; or 0.5 micrograms one day in every 3 days; or 0.7 micrograms one day in every 4 days; or 0.8 micrograms one day in every 5 days; or 1 microgram one day in every 6 to 9 days; or 2 micrograms one day in every 10 to 17 days; or 3 micrograms one day in every 18 to 26 days; or 4 micrograms one day in every 27 to 38 days; or 5 micrograms one day in every 39 to 54 days; or 6 micrograms one day in every 55 to 76 days; or 7 micrograms one day in every 77 to 115 days; or 8 micrograms one day in every 116 or more days.

OEHHA has received 12 written comments on the proposed changes and will be taking them into account when determining next steps.

OEHHA Latest Changes to Proposed Website

The Office of Environmental Health Hazard Assessment (OEHHA) proposed a new website that would provide supplemental information to the public relative to the warnings provided for potential exposures to Proposition 65 listed chemicals. The intent is to allow the public to make informed choices concerning those exposures. The proposed website was first revised in May of 2015 and has been revised a second time. The current revisions address the following:

  • Subsection (a) was modified to more accurately reflect the anticipated functions of the website.
  • Subsection (a) was revised to further clarify the scope of the OEHHA disclaimer.
  • Subsection (b) was modified to establish a 90-day period for a business to respond to a request for information.
  • Subsection (b)(4) was modified to include the source of exposure to a chemical for which an environmental warning is being provided.
  • Subsection (b)(10) was revised as it was too broad.
  • Subsection (c) was modified to remove "sole" and "solely" as the terms were vague.
  • A new subsection (d) was added so that businesses can respond to lead agency requests via trade groups.
  • A new subsection (f) was added to state that a business is not required to provide information to OEHHA that is subject to legal privileges under California law.

The revisions did not address the main concerns in the comments that were received to either drop the proposal altogether, or eliminate the requirement that a business must submit information at OEHHA’s request.

OEHHA Proposes Default Levels for Determining Lead and Arsenic in Certain Foods

The California Code of Regulations Title 27, section 25501 addresses that food for human consumption shall not constitute an “exposure” to California Proposition 65 listed chemicals unless the exposure is due to chemicals that are naturally occurring in the food. Currently the regulation allows a defendant, in determining the amount of a listed Proposition 65 contaminant in a food product, to deduct the amount that is naturally-occurring as a result of absorption or uptake from the soil in which it is grown.

The Office of Environmental Health Hazard Assessment (OEHHA) has proposed default naturally-occurring levels for the following foods:

  • Inorganic arsenic in white rice grain – 60 parts per billion (ppb)
  • Inorganic arsenic in brown rice grain – 130 ppb
  • Lead in raw leafy vegetables – 8.8 ppb
  • Lead in raw non-leafy vegetables – 6.2 ppb
  • Lead in fruit, meat, seafood, eggs, and fresh milk – 6.2 ppb

The above amounts would be subtracted from the measured level of the contaminant in the food product for purposes of determining the exposure level of the chemical to the consumer.

California Attorney General Kamala Harris Introduces Proposition 65 Changes to Curb Frivolous Lawsuits

California State Attorney General Kamala Harris has introduced a series of regulatory changes to Proposition 65 in an effort to help ensure that a greater share of civil penalties paid as a result of related litigation are directed towards protecting the public health in the original spirit of the law. Written comments were accepted by the State Department of Justice through November 9, 2015 after which a public hearing was held. The proposed changes are in four key areas:

  • Attorneys’ Fees
    • The annual summary of settlements consistently shows that attorneys’ fees awards significantly exceed the penalty payments to OEHHA. The theory behind the attorneys’ fees awards is that there is a public benefit which justifies the award.
    • The changes to the regulation require the plaintiff provide evidence that the products were or are above the safe harbor limit and that the reformulation will take these products below the safe harbor level showing a “beneficial use”.
    • The section will also be amended to clarify that in addition to attorneys’ fees, claims for investigation costs need to be justified with records of time spent.
  • Reduction in Civil Penalties
    • The current regulation provides that a settlement with a zero or minimal civil penalty may be appropriate.
    • The proposed changes state that the appropriateness of a minimal penalty is dependent on the facts of the case, require greater proof by the plaintiff that proposed actions instead of civil penalties have a connection to the case, and that the settlement is in the public interest.
  • Alternative Settlement Payments
    • The proposed changes prohibit the use of any alternative settlement payments that have not been reviewed by the court.
  • Reporting Requirements
    • The proposed changes require that any settlements that occur after a 60-day notice are sent, but prior to the filing of a complaint, are reported to the Attorney General’s (AG) office. These settlements will be subject to the same standards as a case that has been filed.
    • Plaintiffs filing complaints or reporting settlements (including out of court) will be required to provide copies to AG Office within 5 days of filing.
California Proposition 65: Recent Settlements and 60-Day Notices

In 1986, California voters approved an initiative, California Proposition 65, to address their growing concerns about exposure to toxic chemicals. Since its origin, there have been many lawsuits which have resulted in reformulations of consumer products containing carcinogenic and reproductively harmful chemicals on the Cal Prop 65 list.

Recent settlements from Q4 of 2015 include the following:

SourceChemicalLimits
Vinyl/PVC HeadphonesDEHP, DBP, BBP, and DINPLess than 1000 ppm DEHP, DBP, BBP, and DINP
Earbud CordsDEHP, BBP, and DBPLess than 1000 ppm DEHP, DBP, and BBP
Nylon Cooking Utensils4,4'-Methylenedianiline Less than or equal to 200 ppm 4,4'-Methylenedianiline and Less than or equal to 10ug/L 4,4'-Methylenedianiline when leached.
Cooking Utensils with Vinyl/PVC GripsDEHP, DBP, BBP, and DINPLess than 1000 ppm DEHP, DBP, BBP, and DINP in each accessible component.
Vinyl/PVC Toiletry BagsDEHP, DBP, BBP, and DINPLess than 1000 ppm DEHP, DBP, BBP, and DINP in each accessible component.
Cosmetic CasesDEHP, DBP, BBP, and DINPLess than 1000 ppm DEHP, DBP, BBP, and DINP in any accessible component (plastic, PVC, or vinyl component that can be touched).
Sewing Kits with Vinyl/PVC Handles DEHPLess than 1000 ppm DEHP in each accessible component.
Children's Play Tents Tris(1,3-dichloro-2-propyl) phosphate (TDCPP), Tris (2-chloroethyl) phosphate (TCEP), and Tris (2, 3-dibromopropyl) phosphate (TDBPP)Cannot manufacturer, distribute, or sell a Children's Play Tent that contains any of the listed chemicals.
Vinyl/PVC Gloves DEHPNo more than 1000 ppm DEHP in any component.
Vinyl/PVC Gloves DINPLess than or equal to 1000 ppm DINP in any component.
Vinyl/PVC Handheld Exercise Weights DEHPNo more than 1000 ppm DEHP
Wallets, Handbags, Purses, and ClutchesLead"Materials or components with the following:Paint or other Surface Coating: Less than or equal to 90 ppm.
Polyvinyl Chloride (PVC): Less than or equal to 200 ppm.
All other materials or components other than cubic zirconia, crystal, glass or rhinestones Less than or equal to 300 ppm.
Vinyl/PVC Garment Bag Shoulder Strap Pads and Vinyl/PVC Golf Club Head CoversLead and DEHPMaximum of 90 ppm Lead and 1000 ppm DEHP
Wine ClutchDEHPLess than or equal to 1000 ppm DEHP in any component.
Glass Jars with Exterior Designs LeadLess than or equal to 90 ppm lead by Method EPA 3050B and Less than or equal to 1.0ug Lead by Method NIOSH 9100.
Tablet CasesDEHPLess than 1000 ppm DEHP in each accessible component.
Soaps and ShampoosCoconut oil diethanolamine condensate (cocamide diethanolamine) Cannot manufacturer, distribute, or sell soaps and shampoos that contain intentionally added cocamide diethanolamine.
Hand tools DEHPNo more than 1000 ppm DEHP.
Vinyl/PVC ToolsDEHP, DBP, BBP, and DINPLess than 1000 ppm DEHP, DBP, BBP, and DINP in any accessible component (plastic, PVC, or vinyl component that can be touched).
Book covers with Vinyl/PVC componentsDEHP, DBP, BBP, and DINPLess than 1000 ppm DEHP, DBP, BBP, and DINP in each accessible component.
Hair Brushes with Vinyl/PVC ComponentsDEHPNo more than 1000 ppm DEHP in any accessible component.
FootwearDEHP and DBPLess than or equal to 1000 ppm DEHP and DBP.
Vinyl/PVC Booster CablesDEHPLess than or equal to 1000 ppm DEHP in any accessible component.
Stools with Vinyl/PVC upholsteryDEHPLess than or equal to 1000 ppm DEHP in any accessible component.
Vinyl/PVC Electrical TapeDEHP, DBP, BBP, and DINPLess than 1000 ppm DEHP, DBP, BBP, and DINP.

In addition, a list of recent 60 day notices for Q4 of 2015, inclusive of the chemicals and products under scrutiny, can be viewed in this chart.

ChemicalProduct / SourceNumber of Notices
4,4'-MethylenedianilineNylon Cooking Utensils1
Acetaldehyde, Formaldehyde GasElectronic Cigarette Devices2
AcrylamideReady to Eat Breakfast Cereals1
Benzo[a]anthracene, Benzo[a]pyrene, Benzo[b]fluoranthene, Benzo[k]fluoranthene, ChryseneTire Swings1
BenzophenoneSunscreen1
CadmiumCacao Powder or Bars5
Cadmium, LeadOysters4
Coconut oil diethanolamine condensateShampoo1
Shaving Cream1
Di(2-ethylhexyl)phthalate (DEHP)Archery Bows with Vinyl/PVC Grips1
Automobile Accessories2
Backpacks1
Bags with Vinyl/PVC Components2
Bath Mats1
Bike Storage Hooks1
Commercial Vehicle Seats with Vinyl/PVC Upholstery1
Crimpers w/Vinyl Grips2
Cup Holders1
Door Handle1
Exercise Armbands with Vinyl/PVC Straps1
Eyeshadow Compacts with Vinyl/PVC Components1
Fish Cooking Tools1
Gloves with Vinyl/PVC Components3
Gripper Pads1
Grooming Accessories1
Hand Tools6
Headphones with Vinyl/PVC Components3
Icemaker Connector1
Inflatable Ring Cushions with Vinyl/PVC Air Valves1
Pencil Case/Bag1
Keychains with Vinyl/PVC Components1
Kitchen Tools3
Password Log Book1
Piping Bag/ Cake Decorating Kit1
Placemats1
Portable Speaker Cases with Vinyl/PVC Cords1
PVC Coated Fencing Products2
PVC Coated Utility Hook3
PVC Rainwear6
PVC Storage Cases1
PVC-Coated Utility Hooks4
Rubber Handle/Selfie Stick1
Sink Mats1
Sprayers with Vinyl/PVC Tubing2
Steering Wheel Cover2
Stethoscopes with Vinyl/PVC Tubing1
Stools with Vinyl/PVC Components1
Suction Hooks1
Suit Storage Bag1
Vinyl Envelopes2
Vinyl Tape2
Vinyl/PVC Audio Cables1
Vinyl/PVC Bags1
Vinyl/PVC Bar Stool Covers1
Vinyl/PVC Bicycle Handle Grips2
Vinyl/PVC Can Openers1
Vinyl/PVC Coated Locks1
Vinyl/PVC Cord Protectors1
Vinyl/PVC Cosmetic Bags1
Vinyl/PVC Dustpan Grips1
Vinyl/PVC Earphone Cords1
Vinyl/PVC Exercise Equipment Hand Grips1
Vinyl/PVC Extension Cords1
Vinyl/PVC Gloves1
Vinyl/PVC Handheld Exercise Weights2
Vinyl/PVC Headphone Components1
Vinyl/PVC Jackets2
Vinyl/PVC Luggage Tags1
Vinyl/PVC Manicure Cases1
Vinyl/PVC Portfolio Covers1
Vinyl/PVC Power Cords1
Vinyl/PVC Toiletry Bags2
Vinyl/PVC Tool Grips6
Vinyl/PVC Tool Pouches 2
Vinyl/PVC Tubing2
Walkers with Vinyl/PVC Seat Upholstery1
Waterproof Vinyl Tarp1
Window Decorations1
Wine Boxes with Vinyl/PVC Handles 1
Di(2-ethylhexyl)phthalate (DEHP), Di-isodecyl phthalate (DIDP), Diisononyl phthalate (DINP)ID Badge Holders1
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP)Gloves; Ear Plugs1
Hose1
Hose Reel1
Toilet Seats1
Vinyl/PVC Exercise mats1
Vinyl/PVC Gloves1
Di(2-ethylhexyl)phthalate (DEHP), LeadHearing Protection with Vinyl/PVC Components1
PVC Product Cases2
PVC/Vinyl Rainsuits3
Di(2-ethylhexyl)phthalate (DEHP), Tris(2-chloroethyl) phosphatePVC Rainwear1
Di-isodecyl phthalate (DIDP), Diisononyl phthalate (DINP)Deck Sprayer2
World Paper Rolled Map1
Diisononyl phthalate (DINP)Coaxial Cable1
Decorative Plastic Fruit1
Drawer Liners1
Extension Cord1
Eyelash Curler Grips1
Hand Tools2
Hand Tools with Vinyl Grips1
Lanyard1
USB Cable1
Vinyl Sauna Suites1
Vinyl/PVC Gloves5
Di-n-butyl phthalate (DBP)Footwear 1
Formaldehyde (gas)Electronic Cigarette Devices1
LeadBackpacks Made with Leather2
Belts Made with Leather1
Brass Boilers1
Brass Couplers1
Brass Door Knocks1
Brass Numbers1
Brass Replacement Closet Rings2
Brass Sprinklers1
Canned Crabmeat1
Cap Nuts1
Ceramicware with Exterior Designs1
Chocolate Peanut Butter Bar9
Clothing Made with Leather, Vinyl or Imitation Leather Materials2
Copper Tubing Kits1
Dried Seafood1
Dried Seaweed Snack Foods3
Dried Shrimp1
Footwear Made With Leather, Vinyl or Imitation Leather Materials3
Ginger Powder1
Glass Oil and Vinegar Bottles with Exterior Designs1
Ground Ginger1
Ground Spices - Cumin1
Hose & Adaptors1
Jam, Marmalade and Preserves Containing Ginger2
Measuring Tape1
Mops with Painted Handles1
Nylon Tubing Kits1
Painted Metal Clamps1
Pry Bars1
Push Buttons1
Replacement Faucet Hoses1
Retainer Rings1
Seasoning Powders1
Seaweed1
Sesame seeds1
Slip Joint Nuts1
Sprinkler Heads1
Topical Skin Care Products Containing Zinc Oxide as an Active Ingredient1
Torches1
Truck Battery Bolt1
Wallets, Handbags, Purses and Clutches Made with Leather, Vinyl or Imitation Leather Materials2
Whole Cinnamon, Whole Ginger1
Lead and lead compounds22 Caliber Cartridges1
Brass Plumbing Fittings5
Canned Mussels1
Ceramic Pitchers1
Curry Powder1
Dietary Supplements20
Dried Seafood1
Dried Shrimp1
Propane Torch1
PVC Light Window Sculpture1
Seaweed10
Slotted Blade Carpet Knife1
Turmeric Powder2
NicotineElectronic Cigarette Devices1
Tris(1,3-dichloro-2-propyl) phosphate (TDCPP)Children's Play Tents1
Cushions with Foam Padding1
Tris(2-chloroethyl) phosphatePVC Rainwear1

INTERNATIONAL NEWS – NORTH AMERICA

Canadian Products Containing Mercury Regulations (SOR/2014-254) are Implemented

Products Containing Mercury Regulations (SOR/2014-254) under the Canadian Environmental Protection Act came into force on November 8, 2015. Any determination of total quantity of mercury made for the purposes of these Regulations must be conducted by a Canadian accrediting body under the International Organization for Standardization standard ISO/IEC 17025:2005 or by a laboratory that is accredited under the Environment Quality Act, R.S.Q., c. Q-2.

The regulations cover all products containing mercury with the exception of:

  • waste;
  • a product that is at the end of its useful life and that is intended to be recycled;
  • a food, drug, or cosmetic as defined in section 2 of the Food and Drugs Act;
  • a veterinary biologic as defined in subsection 2(1) of the Health of Animals Act;
  • a surface coating material as defined in subsection 1(1) of the Surface Coating Materials Regulations or a surface coating material applied to a toy regulated under the Toys Regulations;
  • a pest control product as defined in subsection 2(1) of the Pest Control Products Act;
  • a feed as defined in section 2 of the Feeds Act;
  • a fertilizer as defined in section 2 of the Fertilizers Act;
  • an explosive regulated under the Explosives Act;
  • ammunition and explosives under the direction or control of the Minister of National Defence;
  • a product, other than a battery, that has a mercury concentration of 0.1% or less by weight in homogeneous materials;
  • a battery, other than a button cell battery, that has a mercury concentration of 0.0005% or less by weight in homogeneous materials;
  • beginning on January 1, 2016, a button cell battery that has a mercury concentration of 0.0005% or less by weight in homogeneous materials;
  • from January 1, 2016 until December 31, 2019, a button cell battery that is incorporated into a medical device that is intended to remain in the body for at least 30 consecutive days;
  • ores, concentrates and by-products of metallurgic operations; and
  • an on-road vehicle as defined in subsection 1(1) of the On-Road Vehicle and Engine Emission Regulations that is of the 2016 model year or of a previous model year as determined under section 5 of those Regulations.

Products containing mercury can only be manufactured or imported in Canada if:

  • The product belongs to a product category (listed below) and meets the requirement of maximum total quantity of mercury in the Product:
    • Dental amalgam
    • Specific lamp for general lighting purposes
    • Scientific instruments
    • Professional, commercial and industrial photographic film
    • Medical device
    • Radiation / Infrared light detector
  • The manufacturer or importer applies for and is issued a permit for the product

Permits can be applied for the product if evidence can be provided that there is no technically or economically feasible alternative or substitute. A permit is valid for 3 years after which point it has to be renewed and a label must be attached to the product including information as specified in the regulation.

INTERNATIONAL NEWS – SOUTH AMERICA

Ban on Customized Pacifiers, Baby Bottles and Nipples for Baby Bottles

On October 14, 2015, Brazil's National Institute of Metrology, Quality and Technology (INMETRO) issued Administrative Rule No. 517, 2015, which modifies the conditions regulating the marketing of pacifiers, baby bottles and nipples.

The customisation of these products is now defined as changing the product features from the original certified product, through the adhesion of small parts, such as crystals, pearls, and beads that are generally fixed by glue or adhesives; painting of decorative elements; and alteration of the colour of the product.

Considering the existence of these customisation practices and the potential choking hazards arising from aspiration or ingestion of small parts added to products through subsequent modification, INMETRO prohibits the manufacture, importation, distribution and marketing of these customised children's products in the territory of Brazil.

The rule entered into force on 15 October 2015.

INTERNATIONAL NEWS – EUROPE

EN 14682:2014 Safety of Children’s Clothing – Cords & Drawstrings on Children’s Clothing Harmonised Under the General Product Safety Directive

Effective August 24, 2015, the 2014 revisions of EN 14682 are harmonised under the General Product Safety Directive. EN 14882:2014 covers all children’s clothing including disguise costumes and ski-wear intended to be worn by children up to the age of 14 years. However, it does not apply to child use and child articles, neckties, footwear, gloves, hats, scarves, purses, belts (when sold separately), braces and religious clothing.

The major changes are highlighted below:

  • Fringes are clarified to be classified as a series of decorative cords
  • Free ends of fixed bows are considered as decorative cords
  • The requirements of Section 3.4 Chest and waist area (Zone B) have been revised as noted below:
Clause No. Requirements Garments worn from waist down without shoulder straps, braces, or sleeves; such as trousers, shorts, skirts, briefs, bikini bottoms Other Garments such as shirts, coats, dresses, and dungarees
3.4.1 (a)
3.4.2 (a)
Free ends of drawstrings < 20 cm < 14 cm
3.4.1 (b)
3.4.2 (b)
Protruding loops No free ends
Toggles Must be fixed to the garment
3.4.1 (c)
3.4.2 (c)
Functional cords < 20 cm < 14 cm
3.4.1 (d)
3.4.2 (d)
Decorative cords < 14 cm including any embellishment
3.4.3 Adjusting tabs in waist area < 14 cm
3.4.4 – 3.4.6 Tied belts/sashes < 36 cm from point at which intended to be tied

To read more, click here.

ISO Publishes Revised EN ISO 12312-1:2013 +A1:2015 Standard for Sunglasses

The International Organization for Standardization (ISO) has published revisions to the standard ISO 12312-1:2013 – Eye and Face Protection – sunglasses and related eyewear Part 1: Sunglasses for general use, which is harmonised under Personal Protective Equipment (PPE) Directive 89/686/EEC. The amended standard, published as EN ISO 12312-1:2013 +A1:2015, is expected to be harmonised under the PPE directive in the future.

The main changes to the standard are:

Scope (Section 3) has been deleted and substituted with the following:

"This part of ISO 12312 is not applicable to related eyewear, such as:

  1. eyewear for protection against radiation from artificial light sources, such as those used in solaria;
  2. eye protectors intended for specific sports (e.g. ski goggles or other types);
  3. sunglasses that have been medically prescribed for attenuating solar radiation;
  4. products intended for direct observation of the sun, such as for viewing a partial or annular solar eclipse;
  5. products intended for occupational eye protection.
"

5.2 Transmittance and filter categories

Delete the following sentence:

"Unless the filter is one of the following, category 0 shall not be claimed:

- a filter for which specific protection against any part of the solar spectrum is claimed;

- a photochromic filter in its faded state."

5.3.2.1 General

Delete "the following three requirements" and substitute "the following two requirements".

7.6 Impact resistance of the filter, strength level 2 or 3 (optional specification)

Insert an additional sentence before the note as follows:

"If this requirement is met, testing according to 7.1 (minimum robustness) is not necessary."

To read more, click here.

New Chemical Requirements in Effect under EU Toy Safety Directive

As of December 21, 2015, Bisphenol A and three flame retardants are restricted under published Directives 2014/79/EU and 2014/81/EU in the Official Journal, amending the Toys Safety Directive 2009/48/EC.

The below table summarizes the new requirements:

Substance CAS No. Scope Limit value Citation
Bisphenol A 80-05-7

(1) toys intended for use by children under 36 months or;

(2) other toys intended to be placed in the mouth

≤ 0,1 mg/l (migration limit) in accordance with the methods in EN 71-10:2005 and EN 71-11:2005.’ Directive 2014/81/EU
TCEP 115-96-8 ≤ 5 mg/kg Directive 2014/79/EU
TCPP 13674-84-5 ≤ 5 mg/kg
TDCP 13674-87-8 ≤ 5 mg/kg

In addition, as of December 14, 2015, amendments of the Toy Safety Directive 2009/48/EC to adopt specific limit values for six chemicals as listed below are in effect.

Substance CAS No Limit value Effective Date(s) Source
1,2-Benzisothiazol-3(2H)-one 2634-33-5 5 mg/kg (content limit) December 14, 2015 Directive (EU) 2015/2116
reaction mass of: 5-chloro-2- methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1) 55965-84-9 1 mg/kg (content limit) in aqueous toy materials December 14, 2015 Directive (EU) 2015/2117
5-Chloro-2-methyl-isothiazolin-3(2H)-one 26172-55-4 0.75 mg/kg (content limit) in aqueous toy materials December 14, 2015
2-methylisothiazolin-3(2H)-one 2682-20-4 0.25 mg/kg (content limit) in aqueous toy materials December 14, 2015
Formamide 75-12-7 20 μg/m3 (emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content) December 14, 2015 Directive (EU) 2015/2115

To read more, click here.

New EN 71-5:2015 for Chemical Toys (Sets) other than Experimental Sets Published

On November 13, 2015, EN 71-5:2015 for Chemical Toys (Sets) other than Experimental Sets was published replacing the EN 71-5:2013 edition. This 2015 version of the standard is harmonised under the Toy Safety Directive 2009/48/EC. Any conflicting national standards shall be withdrawn by 31 May, 2016 at the very latest.

The major changes in the standard are highlighted below:

  • The scope is changed by removal of 'Plastic moulding sets' and ‘Ceramic and vitreous enamelling materials supplied in miniature workshop sets’ and adding ‘Polystyrene granules sets’
  • 'Phthalic acid esters with straight-chain aliphatic (C6 upwards except C8) alcohols and mixtures of these esters' (Table 1, clause  5.1) and rationale for 'phthalates' (Annex D) are removed
  • Chemical substance ‘petroleum fraction (60 to 140) °C’ is changed to ‘petroleum fraction (35 to 160) °C’
  • Chemical substance ‘petroleum fraction (135 to 210)°C ‘ is changed to ‘hydrocarbons, C9 -C16, hydrotreated, dearomatized’

To read more, click here.

INTERNATIONAL NEWS – ASIA

India Implements Electronics and IT Goods Requirements for Compulsory Registration Order

On August 7, 2015, The Bureau of Indian Standards (BIS) released a notice in the Gazette of India to extend the implementation date for six product categories covered by the “Electronics and IT Goods (Requirements for Compulsory Registration) Order, 2012”, in Gazette of India on November 13, 2014.

Industry stakeholders have sought more time for compliance to the Order and have had discussions with the regulatory body, BIS, regarding the smooth implementation of this Order. As a result, the date of implementation of the Order was extended to December 1, 2015 for the selected products in below table:

Product Category Number Product Indian Standard Number Title of Indian Standard
16Power Adaptors for IT Equipment"IS 13252 (Part-1):2010"Information Technology Equipment – Safety – General Requirements
17Power Adaptors for Audio, Video and Similar Electronic ApparatusIS 616:2010"Audio, Video and Similar Electronic Apparatus – Safety Requirements "
18UPS / Invertors of rating < 5kVA"IS 16242 (Part-1):2014"General and Safety Requirements for UPS
19DC or AC Supplied Electronic Controlgear for LED Modules"IS 15885 (Part-2/Sec 13):2012 "Safety of Lamp Controlgear Part 2 Particular Requirements Section 13 D.C. or A.C. Supplied Electronic Controlgear for LED Modules
20Sealed Secondary cells / Batteries containing Alkaline or other non-acid Electrolytes for use in portable applicationsIS 16046:2012Secondary Cells and Batteries containing Alkaline or other non-acid Electrolytes – Safety Requirements for Portable sealed secondary cells, and for Batteries made from them, for use in Portable Applications
22Fixed General Purpose LED luminaires"IS 10322 (Part-5/Sec 1):2012 "Luminaries Part 5 Particular Requirements Section 1 Fixed General Purpose Luminaries

To read more, click here.

Hong Kong Proposes Updates to the Safety Standards for Toys and Children’s Products

The Hong Kong Special Administrative Region (HKSAR) Government proposed adopting up-to-date safety standards promulgated by the relevant standards institutions for toys and some children’s products listed in Schedule 2 (“Schedule 2 products”) under the Toys and Children’s Products Safety Ordinance (Cap. 424) (“the Ordinance”). Comments on the proposal were accepted through December 1, 2015.

The specified standards for toys and for four classes of Schedule 2 products have been revised to new versions noted below:

Toy standards
1 New ISO 8124-5:2015 Safety of toys - Part 5: Determination of total concentration of certain elements in toys
2Updated toBS EN 71-1:2014 Safety of toys - Part 1: Mechanical and physical properties
3Updated toBS EN 71-3:2013+A1:2014 Safety of toys – Part 3: Migration of certain elements
4NewBS EN 71-14:2014 Safety of Toys - Part 14: Trampolines for domestic use
Schedule 2 Product Standards
1Updated toAS 2432:2015 Babies’ dummies
2Updated toBS EN 1466:2014 Child use and care articles - Carry cots and stands - Safety requirements and test methods
3Updated toASTM F404-14a Standard Consumer Safety Specification for High Chairs
4Updated toBS EN 71-3:2013+A1:2014 Safety of toys – Part 3: Migration of certain elements

To read more, click here.

This summary is not intended to be exhaustive nor should it be construed as legal advice.
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