The reform bill H.R. 2576 TSCA Modernization Act of 2015, amending the Toxic Substances Control Act of 1976 (TSCA), was passed in the House of Representatives on May 24, 2016 and subsequently passed by unanimous decision in the U.S. Senate on June 7, 2016. The compromise bill proposes amendments in different provisions including state law preemption.
View Story Read MoreWithin the last year, both the U.S. House and Senate passed bills to address the legal impediments to managing chemical risks under TSCA. A single compromise bill, H.R. 2576 - Frank R. Lautenberg Chemical Safety for the 21st Century Act, was posted on the website of the U.S. Senate Committee on Environment and Public Works (EPW) May 20, 2016. Key components of the compromise bill are summarized below:
Section 3 Definition:
Section 4 Testing of Chemical Substances and Mixtures:
Section 5 Manufacturing and Processing Notices:
Section 6 Prioritization, Risk Evaluation and Regulation of Chemical Substances and Mixtures:
Section 8 Reporting and Retention of Information:
Section 12 Exports:
Section 14 Confidential Information:
Section 18 State-Federal Relationship:
The bill now goes to President Obama to be signed into law.
On May 27, 2016, the Food and Drug Administration (FDA) finalized the new Nutrition Facts label for packaged foods to help consumers make better food choices. The final rule impacts food manufacturers, requiring changes to the Nutrition Facts Label as regulated under 21 CFR 101.
View Story Read MoreFigure 1 Original (Left) vs. New (Right) Nutrition Facts Labeling
The new Nutrition Facts label is similar in appearance to the previous label however there are revisions to the content as follows:
Labeling format has been updated:
Apart from labeling information, the serving sizes and requirements have been updated:
There are two compliance stages:
Below is a summary of recently updated ASTM standards that may be of interest to our clients:
View Story Read MoreCPSIA / CFR Reference | ASTM Standard No. | Detail |
- | ASTM F2012-16 | Standard Consumer Safety Specification for Stationary Activity Centers Covers performance requirements, test methods and marking requirements to promote safe use of a stationary activity center by an occupant. |
16 CFR 1112 & 16 CFR 1229 (proposed) | ASTM F2167-16 | 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. |
16 CFR 1112 & 16 CFR 1218 | ASTM F2194-16 | Standard Consumer Safety Specification for Bassinets and Cradles Covers performance requirements, test methods, and marking requirements to promote safe use of bassinets and cradles. |
16 CFR 1226 | ASTM F2236-16 | Standard Consumer Safety Specification for Soft Infant and Toddler Carriers Establishes performance requirements, test methods and marking requirements to promote safe use of soft infant and toddler carriers. |
- | ASTM F2400-16 | Standard Specification for Helmets Used in Pole Vaulting Covers performance requirements for helmets to be used in the activity of pole vaulting. |
- | ASTM F2417-16 | Standard Specification for Fire Safety for Candles Prescribes minimum safety requirements for candles to provide a reasonable degree of safety for normal use with candles, thereby improving personal safety and reducing fires, deaths, and injuries. |
16 CFR 1112, 16 CFR 1130 & 16 CFR 1232 (proposed) | ASTM F2613-16 | Standard Consumer Safety Specification for Children's Chairs and Stools Establishes testing requirements for structural integrity and performance requirements for children’s chairs and stools. It also provides requirements for labeling. |
On May 11, 2015, bisphenol A (BPA) was added to the Proposition 65 list of chemicals known to cause reproductive toxicity based on the reproductive toxicity endpoint. The warning requirement for BPA begins one year after the listing of BPA.
View Story Read MoreStarting May 11, 2016, a warning is required for products, such as those containing polycarbonate plastics and epoxy resins, that contain BPA exceeding the Maximum Allowable Dose Level (MADL), which is 3 micrograms/day (See Regulatory Recap: Issue 2, May 2015).
On May 20, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) added 3 pesticides to the Proposition 65 List. They are tetrachlorvinphos, parathion and malathion.
View Story Read MoreThe added pesticide chemicals meet the requirements for listing as known to the state of California to cause cancer for purposes of Proposition 65. The chemical details are summarized below:
Chemical | Chemical Abstracts Service Number (CAS No.) | Endpoint |
Tetrachlorvinphos | 22248-79-9 | Cancer |
Parathion | 56-38-2 | Cancer |
Malathion | 121-75-5 | Cancer |
OEHHA also states that a decision concerning another proposed pesticide, glyphosate, will be published at a later date and the safe harbor level (No Significant Risk Level, NSRL) for malathion will be proposed before the effective date of warning requirement, May 20, 2017.
On May 18, 2016, The Office of Environmental Health Hazard Assessment (OEHHA) published a new proposed version of its regulations governing Proposition 65 Warnings. The proposal amends the previous version based on the comments received. A new comment period ended on June 6, 2016.
View Story Read MoreThe key changes in the new proposal are summarized below:
On May 5, 2016, New York proposed bill A5612A was passed the state Assembly. The bill was then delivered to Senate as Bill S7507 on the same day. The bill proposes reporting rules and sale prohibition on children’s products containing certain priority chemicals.
View Story Read MoreNo later than 12 months after a priority chemical appears on the list, manufacturers of children’s products are required to report any priority chemicals above the practical quantification limits (PQL). The report shall minimally provide the following information:
Current list of priority chemicals:
Chemical | Chemical Abstracts Service Number (CAS No.) |
Tris (1, 3 dichloro-2-propyl) phosphate | 13674-87-8 |
Benzene | 71-43-2 |
Lead and its compounds (inorganic) | 7439-92-1 |
Mercury and its compounds, including methyl mercury | 7439-97-6 |
Antimony and its compounds | 7440-36-0 |
Formaldehyde | 50-00-0 |
Asbestos | 1332-21-4 |
Arsenic and its compounds including arsenic trioxide and dimethyl arsenic | 7440-38-2 |
Cadmium | 7440-43-9 |
Cobalt and its compounds | 7440-48-4 |
Apart from reporting, starting from January 1, 2019, no person shall sell or distribute children’s products containing above listed priority chemicals. For any newly identified priority chemicals, the prohibition of such chemicals will start 3 years after their identification.
On May 2, 2016, the New York Assembly Introduced Bill A9959 and its Senate version bill is S7230. The bill proposed warning requirements on certain lithium batteries and products containing such batteries. If the bill is passed into law, it will impact manufacturers, distributors and retailers of toys or children’s products that contain small lithium batteries
View Story Read MoreThere are two warning requirements proposed in the bills. First, for any lithium batteries with less than one inch diameter, either sold in New York state or used in product sold in New York, the batteries shall be printed with a warning statement as follows: “WARNING: This is a lithium battery which if swallowed has been known to cause death.”
Second, any product containing lithium batteries (as a power source) with less than one inch diameter shall contain a warning statement on its packaging. The warning shall be as follows: “WARNING: This product is powered by a lithium battery. Due to their small size, lithium batteries can easily be swallowed by children. Ingestion of such batteries has been known to cause death.”
On July 1, 2016, the Toxic Free Toys Act of Albany County in the State of New York becomes effective, restricting the presence of 7 chemicals of concern in children’s products.
View Story Read MoreThe law restricts the concentration of antimony, arsenic, benzene, cadmium, cobalt, lead and mercury in children’s products, unless preempted by a Federal standard. The law applies to children’s products including apparel but excludes certain products or components of products such as batteries, consumer electronics or electronic components, paper products, or a drug, biologic, medical device, food, or food additive regulated by the Food and Drug Administration. (See Regulatory Recap: February 2016).
On April 19, 2016, Mexico Official Journal of the Federation (DOF) published a draft standard, NOM-203-SCFI-2015, to establish the maximum permissible emission limit and content limit for formaldehyde in wood particle board and wood fiberboard.
View Story Read MoreIn NOM-203-SCFI-2015, the limits established are summarized below:
Wood Particle Board | Wood Fiberboard (greater than 8mm thick) |
Wood Fiberboard (less than or equal to 8 mm thick) |
|||
Emission (ppm) | Content (mg/100g) | Emission (ppm) | Content (mg/100g) | Emission (ppm) | Content (mg/100g) |
0.18 | 9.08 | 0.21 | 10.64 | 0.22 | 11.15 |
The draft standard also suggests evaluation methods to demonstrate the compliance to the above limit. For formaldehyde emission, it is evaluated by Mexican Standard NMX-C-462 ONNCCE (Chapter 7.8). For formaldehyde content, it is evaluated by Mexican Standard NMX-C-462 ONNCCE (Chapter 7.9).
On April 23, 2015, Regulation (EU) 2015/628 was published to expand the scope of lead restriction under Regulation (EC) No. 1907/2006 (REACH). The expanded part applies to product placed on the market after June 1, 2016.
View Story Read MoreThe scope of lead restriction was expanded to include articles or accessible parts of articles supplied to the general public, if it may be placed in the mouth by children during normal or foreseeable conditions of use. The lead content limit is 0.05 % by weight (See Regulatory Recap: Issue 2, May 2015).
In Europe, when hazards are identified in consumer products, the products will be recalled and published in the Rapid Alert System, which is updated weekly. The European recalls in May 2016 are summarized below:
View Story Read MoreIn Europe, when hazards are identified in consumer products, the products will be recalled and published in the Rapid Alert System, which is updated weekly. The European recalls in May 2016 are summarized below:
Hazard | Frequency |
Chemical Hazard | 38 |
Choking Hazard | 28 |
Electric shock Hazard | 15 |
Injury Hazard | 12 |
Other Hazards* | 19 |
* Other Hazards include Asphyxiation Hazard, Burn Hazard, Drowning Hazard, Environmental Hazard, Fire Hazard, Hearing Hazard, Microbiological Hazard, Strangulation Hazard and Suffocation Hazard with frequency less than 5.
Product Categories | Frequency |
Toys | 37 |
Electric Appliances | 14 |
Apparel | 12 |
Footwear | 6 |
Other Categories^ | 35 |
^ Other Categories include Bedding, Child Care Articles, Consumer Chemicals, Decorative Products, Gas Detectors, Garden Supplies, Household Appliances, Jewelry, Kitchen Merchandise, Personal Care, Personal Accessories, Sports Equipment and Tools with frequency less than 5.
Recalls Summary - Europe (Last Update Date: May 31, 2016)Reference Number | Notifying Country | Product | Product Category | Hazard(s) | Product Image |
A11/0042/16 | Germany | Fast | Consumer Chemicals | Chemical Hazard | ![]() |
A11/0043/16 | Germany | Trumpet Care Kit | Consumer Chemicals | Chemical Hazard | ![]() |
A11/0044/16 | Germany | Valve Oil | Consumer Chemicals | Chemical Hazard | ![]() |
A11/0045/16 | The Netherlands | Lanterne Volante ('Flying lantern') | Garden Supplies | Fire Hazard | ![]() |
A11/0046/16 | The Netherlands | Himmelslaterne (Sky lantern) | Garden Supplies | Fire Hazard | ![]() |
A11/0047/16 | The Netherlands | Happiness Balloon | Garden Supplies | Fire Hazard | ![]() |
A11/0048/16 | Hungary | Lead Acid Charger | Electric Appliances | Electric shock Hazard | ![]() |
A11/0050/16 | France | Devil Inside | Toys | Choking Hazard | ![]() |
A12/0522/16 | Spain | Boys' Swimming Shorts | Apparel | Injury Hazard | ![]() |
A12/0523/16 | Spain | Ladies' Sandals | Footwear | Chemical Hazard | ![]() |
A12/0525/16 | Spain | Ladies' Sandals | Footwear | Chemical Hazard | ![]() |
A12/0526/16 | Slovakia | Flying a Kite and White Cloud | Toys | Choking Hazard | ![]() |
A12/0527/16 | Germany | Gürtel - Belt | Personal Accessories | Chemical Hazard | ![]() |
A12/0530/16 | Spain | Playme | Toys | Choking Hazard | ![]() |
A12/0532/16 | Spain | Babies' Dungarees | Apparel | Choking Hazard | ![]() |
A12/0533/16 | Spain | Men's Sandals | Footwear | Chemical Hazard | ![]() |
A12/0534/16 | Spain | Soft Bullet Gun | Toys | Choking Hazard | ![]() |
A12/0535/16 | Spain | Angry Birds | Toys | Choking Hazard | ![]() |
A12/0536/16 | Spain | Pull-along Toy | Toys | Choking Hazard | ![]() |
A12/0537/16 | Czech Republic | Yong | Toys | Chemical Hazard | ![]() |
A12/0538/16 | Spain | Kitchen Play Set / Play at Home | Toys | Choking Hazard | ![]() |
A12/0541/16 | Spain | Bubble Stick | Toys | Microbiological Hazard | ![]() |
A12/0542/16 | France | 'Confort' Range | Child Care Articles | Injury Hazard | ![]() |
A12/0544/16 | Spain | Enrollable Manguera | Electric Appliances | Electric shock Hazard | ![]() |
A12/0545/16 | Spain | Beauty - My Vogue Girl | Toys | Chemical Hazard | ![]() |
A12/0546/16 | Spain | Soft Toy | Toys | Choking Hazard | ![]() |
A12/0547/16 | Spain | Girls' Dress | Apparel | Choking Hazard | ![]() |
A12/0548/16 | Germany | Women's Sandals | Footwear | Chemical Hazard | ![]() |
A12/0549/16 | Spain | 'Debbie' - Beautiful girl | Toys | Chemical Hazard | ![]() |
A12/0550/16 | Spain | Doctor Set | Toys | Chemical Hazard | ![]() |
A12/0552/16 | Spain | Baby Clothing Set | Apparel | Choking Hazard | ![]() |
A12/0553/16 | Spain | Heated Towel Rail | Household Appliances | Burn Hazard | ![]() |
A12/0556/16 | Germany | Charms | Jewelry | Chemical Hazard | ![]() |
A12/0557/16 | Germany | Permanent Powder Hair Colour | Personal Care | Chemical Hazard | ![]() |
A12/0562/16 | Italy | Food Jar | Kitchen Merchandise | Chemical Hazard | ![]() |
A12/0563/16 | Italy | Vacuum Flask | Kitchen Merchandise | Chemical Hazard | ![]() |
A12/0564/16 | Italy | Food Jar | Kitchen Merchandise | Chemical Hazard | ![]() |
A12/0568/16 | Spain | Reality Shoes | Footwear | Chemical Hazard | ![]() |
A12/0570/16 | Spain | Push-along Toys | Toys | Choking Hazard | ![]() |
A12/0571/16 | Spain | Adaptador Europeo | Electric Appliances | Electric shock Hazard | ![]() |
A12/0572/16 | Spain | Beaut | Toys | Chemical Hazard | ![]() |
A12/0573/16 | Spain | Children's Shoes | Footwear | Chemical Hazard | ![]() |
A12/0576/16 | Hungary | Children’s Sweatshirt | Apparel | Strangulation Hazard | ![]() |
A12/0577/16 | Hungary | Children’s Sweatshirt | Apparel | Strangulation Hazard | ![]() |
A12/0580/16 | Bulgaria | Children's Outfit | Apparel | Injury Hazard, Strangulation Hazard | ![]() |
A12/0581/16 | Hungary | Rechargeable Working Headlight Helmets / Led Headlight | Electric Appliances | Electric shock Hazard, Fire Hazard | ![]() |
A12/0582/16 | Hungary | ПЕРЕЗАРЯЖАЕМЫЙ АККУМУЛЯТОРНЫЙ СВЕТИЛЬНИК (Rechargeable Lamp) | Electric Appliances | Electric shock Hazard, Fire Hazard | ![]() |
A12/0583/16 | Finland | Small Naughty Love Bath | Toys | Chemical Hazard | ![]() |
A12/0584/16 | United Kingdom | High Lumen LED Spot | Electric Appliances | Electric shock Hazard | ![]() |
A12/0585/16 | United Kingdom | LED Flood Light | Electric Appliances | Electric shock Hazard | ![]() |
A12/0586/16 | Sweden | SafeTmade | Tools | Drowning Hazard | ![]() |
A12/0587/16 | France | Bijoux En Ambre Pour Bebe (amber jewellery for babies) | Child Care Articles | Choking Hazard | ![]() |
A12/0588/16 | Bulgaria | Onyx | Child Care Articles | Injury Hazard | ![]() |
A12/0589/16 | Germany | Die Lieben Sieben | Toys | Chemical Hazard | ![]() |
A12/0590/16 | Slovakia | Lay egg - swan toys | Toys | Choking Hazard | ![]() |
A12/0591/16 | Slovakia | 3-Way Socket with Sugre Protection | Electric Appliances | Electric shock Hazard | ![]() |
A12/0592/16 | Slovakia | Baby Toys | Toys | Choking Hazard | ![]() |
A12/0593/16 | Austria | Easy Rider and Iron Cruiser | Sports Equipment | Injury Hazard | ![]() |
A12/0594/16 | Austria | Index | Sports Equipment | Injury Hazard | ![]() |
A12/0595/16 | Austria | Camalots and Camalot Ultralights | Sports Equipment | Injury Hazard | ![]() |
A12/0597/16 | Hungary | LED Flood Light | Electric Appliances | Electric shock Hazard | ![]() |
A12/0598/16 | Sweden | Pumpkin | Toys | Choking Hazard | ![]() |
A12/0601/16 | Estonia | Baby Rattle - Baby Love Play Set | Toys | Choking Hazard | ![]() |
A12/0604/16 | Hungary | Vintage Night Lamp Porcelain | Electric Appliances | Electric shock Hazard | ![]() |
A12/0607/16 | Hungary | USB Power Adapter | Electric Appliances | Electric shock Hazard | ![]() |
A12/0608/16 | Hungary | TRAVEL Mosquito Plug | Electric Appliances | Electric shock Hazard | ![]() |
A12/0610/16 | France | Children's Fancy Dress/Pyjamas with Hat | Apparel | Chemical Hazard | ![]() |
A12/0611/16 | United Kingdom | Hair Auto Straightener | Personal Care | Electric shock Hazard | ![]() |
A12/0612/16 | Estonia | Discovery Cubes with Animal Puzzle | Toys | Choking Hazard | ![]() |
A12/0615/16 | France | Grappe Raisin PVC (PVC Bunch of Grapes) | Decorative Products | Choking Hazard | ![]() |
A12/0616/16 | Estonia | Winter Princess | Toys | Chemical Hazard | ![]() |
A12/0618/16 | Estonia | Cloetta Spelletta Beautiful Fashion | Toys | Chemical Hazard | ![]() |
A12/0623/16 | Denmark | 4 FLØJTER - 4 Whistles | Toys | Choking Hazard | ![]() |
A12/0624/16 | Slovakia | Beautiful Children | Toys | Chemical Hazard | ![]() |
A12/0625/16 | Finland | LED Panel Light | Electric Appliances | Electric shock Hazard | ![]() |
A12/0626/16 | Finland | Cotton Printed Bed Sheet Double | Bedding | Chemical Hazard | ![]() |
A12/0627/16 | Finland | High Intensity LED Flashlight | Electric Appliances | Electric shock Hazard | ![]() |
A12/0628/16 | Germany | Lederhose Madl | Apparel | Chemical Hazard | ![]() |
A12/0629/16 | Finland | City Police Soft Bullets Gun | Toys | Choking Hazard | ![]() |
A12/0630/16 | Poland | Pull-along toy telephone | Toys | Choking Hazard, Strangulation Hazard, Suffocation Hazard | ![]() |
A12/0631/16 | The Netherlands | 3.8MTelescoop Ladder | Tools | Injury Hazard | ![]() |
A12/0633/16 | Latvia | Kids Tri Scooter | Toys | Choking Hazard | ![]() |
A12/0634/16 | Finland | Treenihanskat Multistrap Musta Traningshandskar | Sports Equipment | Environmental Hazard | ![]() |
A12/0635/16 | Slovakia | Eva Puzzle Mats | Toys | Choking Hazard | ![]() |
A12/0636/16 | Hungary | Children’s Clothing Set | Apparel | Strangulation Hazard | ![]() |
A12/0637/16 | Hungary | Beautiful Pram | Toys | Injury Hazard | ![]() |
A12/0638/16 | France | Amber Necklace | Jewelry | Choking Hazard, Injury Hazard | ![]() |
A12/0639/16 | Czech Republic | My Baby | Toys | Chemical Hazard | ![]() |
A12/0640/16 | Czech Republic | Dreams The Music of My Dreams | Toys | Chemical Hazard | ![]() |
A12/0641/16 | Spain |
1) Dinosaur Egg - Growing Pet; 2) Growing Pet; 3) Dinosaur Egg - Growing Pet |
Toys | Choking Hazard, Injury Hazard | ![]() |
A12/0642/16 | Germany | Tirolerhose | Apparel | Chemical Hazard | ![]() |
A12/0643/16 | Germany | Soft rubber ball | Toys | Chemical Hazard | ![]() |
A12/0644/16 | Germany | Koru - Tribal Black | Consumer Chemicals | Chemical Hazard | ![]() |
A12/0647/16 | Italy | Plastic Grapes | Decorative Products | Choking Hazard | ![]() |
A12/0649/16 | Hungary | Carbon Monoxide and Natural Gas Detector | Gas Detectors | Asphyxiation Hazard | ![]() |
A12/0650/16 | Hungary | LCD Carbon-Monoxide Detector | Gas Detectors | Asphyxiation Hazard | ![]() |
A12/0651/16 | Hungary | Gázérzékelő és Riasztó (Gas Detector and Alarm) | Gas Detectors | Asphyxiation Hazard | ![]() |
A12/0654/16 | Czech Republic | Plastic toy | Toys | Chemical Hazard | ![]() |
A12/0655/16 | Hungary | Purse | Personal Accessories | Chemical Hazard | ![]() |
A12/0656/16 | Hungary | bőr-cérna karkötő (Leather-Thread Wristband) | Jewelry | Chemical Hazard | ![]() |
A12/0658/16 | Bulgaria | Children’s Clothing Set | Apparel | Choking Hazard | ![]() |
A12/0659/16 | Hungary | Monster Cars | Jewelry | Chemical Hazard | ![]() |
A12/0660/16 | Germany | Spirit Motors Chopper III Handschuh | Sports Equipment | Chemical Hazard | ![]() |
A12/0661/16 | Finland | Super Cap Gun .357 Magnum | Toys | Hearing Hazard | ![]() |
On May 11, 2016, the Australian Competition and Consumer Commission (ACCC) published a notice to extend the interim ban on the supply of unsafe self-balancing scooters by 30 days.
View Story Read MoreThe original 60-Day interim ban was expected to end on May 18, 2016. However, an extension notice was issued before the end date. The new interim ban end date is now on June 16, 2016. (See Regulatory Recap: April 2016).
In January 2016, the Ministry of Industry and Information Technology of the People’s Republic of China (MIIT) issued China RoHS 2 (See Regulatory Recap: March 2016). Prior to the July 1, 2016 effective date, a Frequently Asked Questions (FAQ) related to the implementation of China RoHS 2 was published.
View Story Read MoreThe FAQ provides clarification of the China RoHS 2 regulation as summarized below:
After mandating the Indonesia National Standards (NSI) and EN 71 part 5 for toy’s safety, the Minister of Industry appointed domestic accredited laboratories to perform testing. The minister also appointed non-Indonesian laboratories to perform testing for not more than 2 years.
View Story Read MoreOn April 16, 2016, the period allowing non-Indonesian laboratories to test toys expired and now toys imported to Indonesia must be tested by approved laboratory in Indonesia according to the amendment Decree No. 55/M-IND/PER/11/2013. Unless laboratories have been registered in the Mutual Recognition Agreement (MRA) in APLAC / ILAC, toys manufactured outside Indonesia must be tested by approved Indonesia laboratories.
On April 18, 2016, the Ministry of Health and Welfare (MOHW) published Notice 1041304938 to establish additional labeling requirements for food utensils, containers or packaging. The additional requirements will enter into force on July 1, 2017.
View Story Read MoreThe requirements are established according to the articles 26 of the Act Governing Food Safety and Sanitation and they are summarized below:
This summary is not intended to be exhaustive nor should it be construed as legal advice.
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