Global Regulatory Update



ACLASS Changes to ANAB

The ANSI-ASQ National Accreditation Board has moved to the single brand ANAB from the previous three brands: ANAB, ACLASS, and FQS. ANAB is a signatory of the multilateral recognition arrangements (MRAs) of the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC). ANAB is well recognized in both the United States and internationally. The AI/ANSECO Group laboratories will be incorporating the ANAB logo on test reports as our renewed ISO 17025 accreditation certificates and scopes become updated with the new logo.


USA FEDERAL NEWS


CPSC Exempts Untreated Trunk Wood From Third-Party Heavy Metals Testing

The U.S. Consumer Product Safety Commission (CPSC) has published a direct final rule determining that unfinished and untreated trunk wood does not contain heavy elements that would exceed the limits specified in the toy safety standard ASTM F963-11.   Therefore, unfinished and untreated wood in toys will not require third party testing for the heavy elements listed in ASTM F963-11.   The new rule at 16 CFR Part 1251 is not applicable to pressed wood, plywood, particle board nor wood that has been treated or finished as defined in the rule.

The rule is anticipated to become effective September 15, 2015 unless adverse comments are received by August 17, 2015. To read more click here 80 FR 42376.


Updates to ASTM Standards

Below is a summary of updated ASTM standards that may be of interest to our clients for the second quarter of this year:

CPSIA / CFR Reference ASTM Standard No.  
Durable Nursery Goods with no CPSIA rule yet ASTM F2167-15 Standard Consumer Safety Specification for Infant Bouncer Seats Covers establishment of requirements, test methods, and marking requirements to promote safe use of an infant bouncer seat by an occupant and a caregiver.
- ASTM F1045-15 Ice Hockey Helmets Covers performance requirements for ice hockey helmets.
Durable Nursery Goods16 CFR 1233 (Proposed rule) ASTM F1235-15 Portable Hook-On Chairs Covers the performance requirements and test methods designed to ensure the satisfactory performance of the portable hook-on chair.
16 CFR 1500.18(a)(12)16 CFR 1512 ASTM F1952-15 Downhill Mountain Bicycle Racing Covers performance requirements for helmets used by downhill mountain bicycle riders which require greater impact protection and provides performance criteria for chin bars on full-face helmets, but does not require full-face helmets. This specification recognizes the desirability of lightweight construction and ventilation, however, it is a performance specification and is not intended to restrict design.
16 CFR 1203 ASTM F2032-15 Helmets Used for BMX Cycling Covers performance requirements for helmets used in BMX cycling which require impact protection over a larger area of the head. Performance criteria for helmets equipped with chin bars is provided. Retention system tests shall be performed before impact testing. The chin bar rigidity test only applies to helmets with a chin bar.
Durable Nursery Goods with no CPSIA rule yet ASTM F2388-15 Standard Consumer Safety Specification for Baby Changing Tables for Domestic Use Covers performance requirements, test methods, and labelling requirements to promote the safe use of baby changing tables and other changing products such as contoured changing pads and add-on changing units that are sold separately for use on furniture products other than changing tables.
Durable Nursery Goods with no CPSIA rule yet ASTM F404-14a Standard Consumer Safety Specification for High Chairs Covers the performance requirements and test methods 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.
- ASTM F1898-15 Standard Specification for Helmets for Non-Motorized Wheeled Vehicles Used by Infants and Toddlers Covers performance requirements for helmets manufactured for use by infants and toddlers as passengers or operators of non-motorized vehicles intended for their use. This specification recognizes the desirability of lightweight construction and ventilation; however, it is a performance standard and is not intended to restrict design.
16 CFR 1217 ASTM F1821-15 Standard Consumer Safety Specification for Toddler Beds Covers requirements for the design and performance of toddler beds. It also contains requirements for labelling and instructional material.


USA STATE NEWS


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 Q2 of 2015 include the following:

Source Chemical Limits
Medical marijuana; Paraphernalia for Smoking Marijuana;  Marijuana smoke Warnings
Shampoo Coconut oil diethanolamine condensate (cocamide diethanolamine) Remove Chemical in Reformulation
Gas Appliance Connectors Lead and lead compounds Warnings
Luggage Tags with Vinyl/PVC Straps Di(2-ethylhexyl)phthalate Less than 1000 ppm DEHP in accessible components
Travel Organizers Lead Less than 100 ppm Lead in accessible components
Vinyl/PVC Electrical Tape Di(2-ethylhexyl)phthalate Less than 1000 ppm DEHP
Clothing Made with Leather, Vinyl or Imitation Leather Materials Lead Paint Less than 90ppm; PVC Less than 200 ppm, Other material Less than 300 ppm
Tools with Vinyl/PVC Grips Di(2-ethylhexyl)phthalate, Din-n-Butyl Phthalate, Butyl Benzyl Phthalate Less than 1000 ppm DEHP, DBP, and BBP in accessible components

In addition, a list of recent 60 day notices for Q2 of 2015, inclusive of the chemicals and products under scrutiny can be viewed in this chart.  Reg Update Q2 - Prop 65 60 Day Notices


Various States and Counties Take Action Against Toxic Toys and Children’s Products

Concerns over toxic chemicals, particularly in children’s products, continue to be addressed at the state level as the Toxic Substances Control Act (TSCA) modernization moves to the U.S. Senate. In addition to state level legislation, several counties in New York State have passed laws banning or restricting chemicals in products intended for children.   Those listed below are in addition to Albany County’s Toxic Free Toys Act, which is supposed to go into effect early 2016 but is currently paused until concerns raised by an industry coalition lawsuit are addressed.  See table below for further information.


Chemicals of High Concern

Legislation Effective Date(s) Source
Westchester County (New York) Local Law LL-2015-8 prohibits formaldehyde, benzene, lead, mercury, antimony, arsenic, cadmium and cobalt in children's products.  Approved by the County Executive May 14, 2015.  This law has a provision to be null and void if the state adopts a similar law (see below). Effective May 14, 2016 LL-2015-8
Suffolk County (New York) enacted the Toxic Free Toys Act which prohibits the following metals in children’s products above the stated limits: 90 ppm lead in surface coatings; 100 ppm lead content in accessible parts; 75 ppm cadmium; 40 ppm for each of the metal elements mercury, antimony, arsenic, cobalt. January 1, 2016: Department of Health Services (DHS) to inform retailers of requirements of  law;July 1, 2016: retailers may not knowingly sell;December 1, 2016: random testing by DHS for enforcement Intro. Res. No. 1382-2015
Rockland County (New York) Local Law no. 3 prohibits any individual or business from selling within the county, children’s apparel or children’s products, including toys that contain benzene, lead, mercury, antimony, arsenic, cadmium or cobalt. Effective October 12, 2015 Local Law No. 3 of 2015
New York bill S4102-2015 requires the Department of Environmental Conservation (DEC) to post lists of priority chemicals and chemicals of high concern on the department's website within 180 days of the effective date with periodic review to add or remove chemicals as well as reporting provisions for manufacturers of children’s products containing priority chemicals.New York bill S4102 would preempt local laws and would require manufacturers of children's products to notify retailers when the merchandise they are selling contains one of the DEC listed chemicals, and it also would prohibit the sale of children's products that contain the most harmful chemicals.  S4102A adds specific chemical levels that must not be exceeded in certain products. April 1, 2016 with sales prohibition January 1, 2018 S4102A
Oregon bill SB 478 passed into law and establishes a list of high priority chemicals of concern for children that are used in children’s products.It requires the Oregon Health Authority (OHA) to establish a list of designated high priority chemicals of concern for children's health used in children's products and to periodically review and revise the list.  It requires manufacturers of certain children's products to provide notice to OHA regarding chemicals on the list and allows OHA to participate in Interstate Chemicals Clearinghouse. Operative Date January 1, 2016  SB 478

Proposed State Legislation

There have been a number of new developments in various USA State laws. See tables below for an overview of these changes:

Bisphenol A

Legislation Effective dates Source
Massachusetts bill S.1223 (2015) would prohibit sale of "any toy, child care article, bottle, cup, or other container, that contains bisphenol A if that container is designed or intended to be filled with any liquid, food, or beverage primarily for consumption from that container."  Here, “toy” means for children 3 years and younger; “bottle” includes sports bottles. January 1, 2016 S. 1223

Phthalates

Legislation Effective dates Source
Maine rule at 06-096-888 designates from the list of Chemicals of High Concern, four phthalates as Priority Chemicals requiring reporting in certain children’s products [DEHP, DBP, BBP and diethyl phthalate (DEP)]. Rule became effective June 22, 2015 with reporting 180 days after this date. phthalates Ch 888

Flame retardants

Legislation Effective dates Source
Minnesota has enacted a bill that bans TDCPP, TCEP, decabromodiphenyl ether and hexabromocyclododecane in children's products and upholstered furniture.  Children's products do not include toys falling under ASTM F963.  Child is a person under 12 years of age. The ban is set at 1000 ppm.  Law is effective August 1, 2015.  Aspects of the law will be in force July 1, 2018 for manufacturers and July 1, 2019 for retailers. SF 1215 3rd Engrossment (bill approved by governor)
New York bill A7837 would prohibit the use of any halogenated flame retardant in residential upholstered furniture.  Includes all products, not just children's products.  Manufacturers also must certify to the state that the furniture meets the "Open Flame Flammability standard" to be developed.  The standard requires that there will not be flashover for 15 minutes time. Effective 30 days after becoming law; July 1, 2016 ban on sale; June 1, 2018 must meet the standard; Dec. 1, 2018 must certify. A7837
State of Washington bill SB 5056 proposes a limited ban on TDCPP, TCEP, decabromodiphenyl ether and hexabromocyclododecane amending RCW 70.240 Reintroduced May 29, 2015 - Prohibits manufacturers and retailers from manufacturing or offering for sale children's products (includes toys, cosmetics, child care articles and jewelry) or residential upholstered furniture containing the specified flame retardants in amounts above 1000 ppm.  Effective date is July 1, 2016 for manufacturers and retailers SB 5056 2nd substitute bill

Chemicals of High Concern

Legislation Effective dates Source
State of Washington bill SB 6131 would require the DOE to develop chemical action plans that ultimately would be used to identify action needed to protect human health and the environment.  Manufacturers upon request would be required to furnish information to DOE on chemicals in their products.  Products are commercial or residential.   Beginning Jan 1, 2016 and every two years thereafter, up to two chemicals would be selected from a set of sources. upon becoming law SB 6131

California Proposition 65

Legislation Effective dates Source
California adds bisphenol A to Proposition 65 list.  Warning label required one year after addition to list. May 11, 2016 Notice
California adds atrazine, propazine, simazine, des-ethyl atrazine (DEA), des-isopropyl atrazine (DIA) and 2,3-diamino-6-chloro-s-triazine (DACT) to Proposition 65 list.  Warning required one year after effective date. October 1, 2016 Notice


INTERNATIONAL NEWS – NORTH AMERICA


Canadian Government Celebrates Product Safety Achievements

On June 19, 2015, members of the Canadian Government celebrated the fourth anniversary of the coming into force of the Canada Consumer Product Safety Act (CCPSA) by highlighting some of the its achievements in protecting Canadians from consumer products that pose a danger to human health or safety.

Over the past four years, since the coming into force of the CCPSA, the Government has:

To read more, click here.


Canada: Consumer Product Enforcement Summary, March 2015

In March, 2015, Health Canada’s Consumer Product Safety Program (CPSP) provided a summary report to industry and consumers on products that were reviewed by Health Canada.  The report indicates which products meet or do not meet safety standards and includes:

Consumer Product Enforcement Summary Reports are produced by Health Canada at the end of each planned enforcement project.  To read more, click here.


Mexico Launches Updated Standard for Electrical Products

On May 28, 2015, the Mexican government launched the updated standard “NOM-003-SCFI-2014E – Electrical Products Safety Specification”. The new requirements will come into force on May 27, 2016, with the exception of the conformity assessment requirements for electrical tools and seasonal decorative products. Electrical tools are subject to Mexican norms NMX-J-038/1-ANCE-2005 and NMX-J524/2-6-ANCE-2013 and the conformity assessment requirements for seasonal decorative products are subject to NMX-J-588-ANCE-2012, which will become effective on May 27, 2017.

Additionally, NOM-003-SCFI-2014 requires electrical products to be designed and constructed to protect the consumer according to various electrical, chemical, mechanical, and thermal hazards.



INTERNATIONAL NEWS - EUROPE


EU: Safety of Toys, Directive 2009/48/EC - Proposed Amendment

In May and June, 2015, The European Commission (EU) issued proposed amendments of Safety of Toys, Directive 2009/48/EC, to adopt specific limit values for 6 chemicals.  If adopted, Appendix C of Annex II to Directive 2009/48/EC would be amended to include a content limit for 6 chemicals in toys as outlined in the table below:

Substance CAS No. Limit Value Effective Date(s) Source
1,2-Benzisothiazol-3(2H)-one 2634-33-5 5 mg/kg (content limit) in aqueous toy materials, in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005 In force 20 days after publication in Official Journal; to be applied 18 months thereafter. Draft Directive D039794/02
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 In force 20 days after publication in Official Journal; to be applied 24 months thereafter. Draft Directive D039780/02
5-Chloro-2-methyl-isothiazolin-3(2H)-one 26172-55-4 0.75 mg/kg (content limit) in aqueous toy materials In force 20 days after publication in Official Journal; to be applied 24 months thereafter. Draft Directive D039780/02
2-methylisothiazolin-3(2H)-one 2682-20-4 0.25 mg/kg (content limit) in aqueous toy materials In force 20 days after publication in Official Journal; to be applied 24 months thereafter. Draft Directive D039780/02
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) In force 20 days after publication in Official Journal; to be applied 18 months thereafter. Draft Directive D039821/02
Phenol 108-95-2 5 mg/L (migration limit) in polymeric materials;10 mg/kg (content limit) as a preservative;Compliance with both limits is to be determined in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005. In force 20 days after publication in Official Journal; to be applied 18 months thereafter. D039805/01

RoHS

Legislation Effective Date(s) Source
EU Directive (EU) 2015/863 amends RoHS Directive 2011/65/EU by adding DEHP, BBP, DBP and DIBP to have maximum concentrations of 0.1% in electrical and electronic equipment. Entered into force June 24, 2015 and applied from June 22, 2019. (EU) 2015/863

Candidate List Expanded to Include Two New SVHCs

On June 15, 2015, the European Chemicals Agency (ECHA) added 2 new Substances of Very High Concern (SVHC) with reproductive toxicity properties and very persistent and very bioaccumulative properties respectively to the SVHC Candidate List which brings the total to 163 substances.

The two new specific chemical additions are:

  1. 1,2-benzenedicarboxylic acid, di-C6-10- alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)
  2. 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en- 1-yl)-5-methyl-1,3-dioxane [1], 5-secbutyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5- methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]

The notification of SVHCs in articles shall be made within 6 months after their inclusion on the List. The notification deadline for the two new SVHCs added to the Candidate List is December 15, 2015.

To read more click here.



INTERNATIONAL NEWS - ASIA


China Introduces Mandatory Standard for Children’s Textile Products

In June 2015, GB 31701-2015 “Safety Technical Code for Infants and Children Textile Products” became a mandatory national standard in China and will come into effect on June 1, 2016 with a 2-year transition period (June 1, 2016 to May 31, 2018). During the transition period, products that are manufactured before June 1, 2016 and fulfill certain standards are still permitted for sale in the market. Starting from June 1, 2018, all products released into the market must comply with this standard.

Categorization according to age:

Classification of safety categories:

Enhancement of safety requirements: