November 2017



North America News

On March 30, 2017, the US Consumer Product Safety Commission (CPSC) issued Final Rule 16 CFR 1234 in the Federal Register 82 FR 15615 regarding the safety standard adoption for infant bath tubs. The final rule was effective on October 2, 2017.

In the final rule, the ASTM F2670-17 Standard Consumer Safety Specification for Infant Bath Tubs is adopted. An infant bath tub is defined as a tub, enclosure, or other similar product intended to hold water and be placed into an adult bath tub, sink, or on top of other surfaces to provide support or containment, or both, for an infant in a reclining, sitting, or standing position during bathing by a caregiver. Products commonly known as bath slings typically made of fabric or mesh are excluded from the scope of the standard.

Below is a summary of recently updated ASTM standards:

ASTM Standard No.

Detail

ASTM F2388-17a

Standard Consumer Safety Specification for Baby Changing Products for Domestic Use

Covers performance requirements, test methods, and labeling requirements to promote the safe use of baby changing products including changing tables, changing table accessories, contoured changing pads, and add-on changing units.

ASTM F2613-17a

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.

ASTM F2417-17

Standard Specification for Fire Safety for Candles

Prescribes minimum safety requirements for candles and candle ensembles to provide a reasonable degree of safety for normal use with candles, thereby improving personal safety and reducing fires, deaths, and injuries.

ASTM F3118-17a

Standard Consumer Safety Specification for Infant Inclined Sleep Products

Establishes safety performance requirements, test methods, and labeling requirements to minimize the hazards to infants presented by infant inclined sleep products as identified in the introduction.

ASTM F2057-17

Standard Safety Specification for Clothing Storage Units

Intends to reduce injuries and deaths of children from hazards associated with tipover of free-standing clothing storage units, such as chests, door chests and dressers, over 30 in. (762 mm) in height.

On October 27, 2017, the US Consumer Product Safety Commission (CPSC) issued Final Rule 16 CFR 1307 in the Federal Register 82 FR 49938 to approve updates regarding the prohibition of children’s toys and child care articles containing certain phthalates.

The Final Rule updates the Consumer Product Safety Improvement Act (CPSIA), Section 108, as summarized below:

  1. The interim prohibition of DINP for any children’s toys and child care articles that can be placed in a child’s mouth has been revised to a permanent prohibition.

  2. Four additional phthalates are now prohibited:

    • Diisobutyl Phthalate (DIBP)

    • Di-n-pentyl Phthalate (DPENP)

    • Di-n-hexyl Phthalate (DHEXP)

    • Dicyclohexyl Phthalate (DCHP)

  3. The interim ban of DNOP and DIDP has been removed since they do not lead to certain developmental reproductive toxicity according to the Chronic Hazard Advisory Panel (CHAP)’s advice.

The rule will become effective on April 25, 2018. Upon enforcement, any children’s toy or child care article that contains concentrations over 0.1 percent of DEHP, DBP, BBP, DINP, DIBP, DEPENP, DHEXP and DCHP is prohibited.

On October 3, 2017, House Bill H5082, An Act Relating the Health and Safety - Child Products and Upholstered Furniture entered into force without the Governor’s signature. The implementation date of the rule will be July 1, 2018.

Upon enforcement, manufacturers, wholesalers and retailers cannot manufacture, knowingly sell, offer for sale or distribute for use in the state any children’s product or residential upholstered bedding or furniture, which contains over 100 ppm of any organohalogen flame retardant chemical applied to plastic, foam or textile. The implementation schedule is summarized as below:

Products

Implementation Date

1.

Residential upholstered bedding or furniture (children’s product)

July 1, 2018

2.

Residential upholstered bedding or furniture (non-children’s product)

July 1, 2019

Ninety days before the implementation date of the prohibition, a manufacturer of products that are prohibited shall notify persons or entities that sell the products in the state.

On October 26, 2017, the Environmental Protection Agency (EPA) proposed rule, 40 CFR 713 under the Toxic Substances Control Act (TSCA) to require applicable persons to provide information to assist in the preparation of an inventory of mercury and its supply, use, and trade in the United States.

Upon approval, any person who manufactures or imports mercury or mercury added products (including mercury compounds) or otherwise intentionally uses mercury in a manufacturing process is required to report to the EPA.

The proposed rule is now receiving comments until December 26, 2017.

In Canada, when hazards are identified in consumer products, they will be recalled and published in the Recalls and Safety Alerts Database on the Health Canada website, which is updated daily. The Canada recalls from May 1 to October 31, 2017 are summarized below:

Hazards

Frequency

Chemical Hazard

19

Choking Hazard

15

Burn Hazard

12

Fall Hazard

12

Fire Hazard

10

Laceration Hazard

10

Other Hazards*

45

*Other Hazards include Cut Hazard, Electric Shock Hazard, Entrapment Hazard, Injury Hazard, Microbial Hazard, Product Safety, Strangulation Hazard, Tip-Over Hazard, Violation to Certification Requirements, Violation of Consumer Chemicals and Containers Regulations, Violation of Cribs, Cradles and Bassinets Regulations, Violation of Flammability Regulation and Violation to Packaging and Labeling Requirements with a frequency of less than 10.

Product Categories

Frequency

Toys and Childcare Articles

22

Sporting Goods / Equipment

12

Cosmetics / Bodycare

10

Fabric / Textile / Garment / Home Textile

9

Juvenile Products

7

Other Categories^

42

^Other Categories include Candles & Burning Items and Accessories, Children's Products, Computer / Audio / Video / Other Electronics & Accessories, Consumer Chemicals, Food Contact Material, Footwear, Furniture, Home Electrical Appliances (Hair Dryer, Iron, etc.), Homeware (Non-food Contact), Jewelry, Watch or other Fashion Accessories, Lighting Equipment and Tools and Hardware with a frequency of less than 8.

For the complete list click here

On September 15, 2017, the Federal Trade Commission (FTC) announced that the Registered Identification Number (RN) Webpage has been updated to allow real-time data validation for applicants and alert them to possible errors to avoid unnecessary delays.

Under the current rule, most clothing, textile and fur products are required to have a label identifying the manufacturer or other business responsible for handling the item. The updated webpage allowing real-time data validation of RN makes it easier for companies to obtain an RN, which can avoid putting long company names on labels. The use of the updated RN webpage will streamline the application process for participating businesses and increase the efficiency to deliver RN services.

On October 26, 2017, the Consumer Product Safety Commission (CPSC) issued a Final Decision and Order holding that Zen Magnets are a substantial product hazard.

In the final decision and order, CPSC Commissioners held that Zen Magnets are defective, and that the defect creates a substantial risk of injury to the public. Additionally, they found that it is reasonably foreseeable that children will ingest Zen Magnets and the warnings do not mitigate the risk. When two or more magnets are ingested, they can attract to each other or to other ingested metallic objects resulting in catastrophic injuries or death. Therefore, it is illegal under federal law for any person to sell, offer for sale, manufacture, distribute or import into the United States any Zen Magnets.

On November 4, 2017, Health Canada proposed an amendment to SOR/2011-17 Toys Regulations through the Canada Gazette. The amendment proposes to add a magnetic toys requirement due to ingestion hazards resulting in serious damage to intestinal tissues and long-term health consequences.

The key amendments, which are aligned with few exceptions to ASTM F963-16, are summarized below:

  1. Updated definitions

  2. Added requirements for magnetic toys: any magnetic toy or magnetic component that is a small part shall have a magnetic flux index of less than 0.5 T2mm2, except a magnetic component that is:

    1. Necessary for the operation of motors, relays, speakers and other electrical components in a magnetic toy, provided that the magnetic properties are not part of the play or learning pattern of the toy; and

    2. Part of a kit intended for carrying out educational experiments involving both magnetism and electricity. The product shall be intended for a child of at least 8 years of age and labeled with appropriate warnings.

  3. Added testing method for magnetic flux index measurements

  4. Added warning requirements for magnetic toys that are intended for carrying out educational experiments

Asia News

Em 3 de outubro de 2017, o Comitê de Representantes da Câmara da República das Filipinas aprovou os seguintes quatro projetos de lei relacionados à rotulagem de segurança e aos requisitos de produtos químicos perigosos em brinquedos infantis, materiais escolares e artigos de cuidados infantis:

  • Projeto de lei 0321 da Câmara: uma lei que regulamenta a importação, fabricação, distribuição e venda de brinquedos infantis, material escolar, artigos de puericultura e outros produtos relacionados que contenham produtos químicos perigosos e prevê penalidades para violações desse tipo de lei

  • Projeto de lei 02349 da Câmara: uma lei que prevê a rotulagem de segurança de brinquedos e jogos, destinando fundos para isso

  • Projeto de lei 03043 da Câmara: uma lei que proíbe a venda de brinquedos e outros artigos que contenham ftalatos para crianças com três anos de idade ou menos

  • Projeto de lei 03943 da Câmara: uma lei que regulamenta a importação, fabricação, distribuição e venda de brinquedos infantis, material escolar, artigos de puericultura e outros produtos relacionados que contenham produtos químicos perigosos e prevê penalidades para violações desse tipo de lei

Os principais requisitos das quatro leis aprovadas estão resumidos abaixo:

Produtos

Requisitos

Artigo sobre cuidados infantis

Qualquer produto destinado a facilitar o sono, o relaxamento, a higiene, a alimentação de crianças ou a sucção por parte de crianças (com menos de 14 anos de idade).

Brinquedos infantis

Qualquer produto ou material projetado e claramente destinado ao uso em brincadeiras por crianças com menos de 14 anos de idade.

Implementação na escola

Uma ferramenta usada por crianças para escrever, desenhar, colorir, marcar, colar ou apagar que provavelmente será lambida ou levada à boca.

Material escolar

Itens ou artigos usados para fins educacionais que provavelmente não serão colocados na boca de crianças.

Dentro de três meses a partir da data de vigência desta lei, a Administração de Alimentos e Medicamentos das Filipinas (FDA) deverá preparar uma lista de produtos químicos e substâncias proibidas que possam causar danos, lesões ou morte às crianças. Na lista, os seguintes produtos químicos também deverão ser incluídos:

Item

Produtos químicos

Método de teste

1

Metais tóxicos:

Antimônio

Arsênico

Cádmio

Cromo

Liderança

Mercúrio

Para os metais pesados identificados no PNS/ISO 8124-3, é necessário estar em conformidade com um dos seguintes padrões :

ISO 8124-3, ou

EN-71-3, ou

ASTM F963

2

Ftalatos:

Ftalato de di-(2-etil-hexila) (DEHP)

Ftalato de dibutilo (DBP)

Ftalato de benzilbutila (BBP)

Ftalato de diisononila (DINP)

Ftalato de diisodecila (DIDP)

Ftalato de di-n-octilo (DnOP)

Para ftalatos, é necessário estar em conformidade com um dos seguintes:

Seção 108 da Lei de Melhoria da Segurança de Produtos de Consumo (CPSIA) dos EUA , ou

Entrada 52 do Anexo XVII do Regulamento REACH da Europa 1907/2006

3

Bisfenol A (BPA)

Não especificado

(Consulte test).

Todos os brinquedos ou jogos que contenham os seguintes componentes devem conter um aviso adequado na embalagem:

  1. Parte pequena destinada ao uso por crianças com menos de 14 anos de idade

  2. Qualquer bola de gude destinada ao uso por crianças com menos de 14 anos de idade

  3. Qualquer balão de látex ou qualquer bola com diâmetro de 1,75 polegadas ou menos destinada ao uso por crianças com menos de 10 anos de idade

A declaração de advertência no rótulo de aviso deve ser escrita em inglês, filipino ou em ambos os idiomas.

(Consulte test).

Assine nossas Atualizações Regulatórias

Cancelar a assinatura a qualquer momento. Leia nossa política de privacidade.