November 2016

On September 9, 2016, the Consumer Product Safety Commission (CPSC) published technical report: Exposure Assessment: Potential for the Presence of Phthalates in Specified Materials at Concentrations Above 0.1 Percent. The assessment was conducted by the Toxicology Excellence for Risk Assessment Center at the University of Cincinnati (TERA).

Previously, the CPSC had proposed to exempt four plastics from phthalates testing. (See test). In support of the CPSC’s continued efforts to reduce third party testing burden, TERA has studied an additional eleven plastics to determine the presence of ten specified phthalates including the six Consumer Product Safety Improvement Act (CPSIA) regulated phthalates. The results of study may lead to further inclusion of plastics that are proposed to be exempted from CPSIA phthalate testing.

The overview of phthalates found in certain plastics is summarized below:

Remarks: 1: Study found that the presence of DBP could be additives. 2: One study reported DBP at unspecified concentration in an unspecified toy.

On September 28, 2016, House Bill H.R. 6269 (Identical Senate Bill S. 3412) was introduced in the House of Representatives. The bill proposed to ban the use of Bisphenol A (BPA) in food containers.

The proposed bill bans the following food containers composed of BPA or which can release BPA into food:

1. Reusable food containers; and

2. Other food containers that are packed with food and are introduced or delivered for introduction into interstate commerce

Despite the proposed ban, the Food and Drug Administration (FDA) may grant waivers to a particular facility (defined in section 415 of the Federal Food, Drug, and Cosmetic Act) that manufactures, processes, packs holds or sells food product. However, the facility receiving such waivers must:

1. Demonstrate that it is not feasible to replace BPA in the certain type of container

2. Demonstrate that is it not feasible to use an alternative container without BPA

3. Have a plan and timeline for BPA removal

4. Display a prominent warning label on the product as below: “Bisphenol A (BPA) is a chemical that can leach into food and may harm prenatal development and the health of children and adults.”

Below is a summary of recently updated ASTM standards that may be of interest to our clients:

El 20 de octubre de 2016, se publicó una nueva versión (2016) de la norma ASTM F963. El resumen de la revisión figura a continuación.

Norma ASTM F963 sobre seguridad de los juguetes

ASTM F963 ha sido durante mucho tiempo una norma clave para las pruebas de seguridad de los juguetes. Esta norma aborda los requisitos de seguridad de los juguetes, que son cualquier objeto diseñado, fabricado o comercializado como juguete para niños menores de 14 años (excluidos los productos enumerados en el Apéndice A).

Según la Ley de Mejora de la Seguridad de los Productos de Consumo (CPSIA), la norma actualizada entrará en vigor y será obligatoria 180 días después de que ASTM haya notificado la actualización a la Comisión de Seguridad de los Productos de Consumo (CPSC). No obstante, la CPSC puede rechazar la revisión en un plazo de 90 días.

Se modifican los siguientes requisitos o métodos de ensayo:

Para más información, consulte nuestra página sobre la norma ASTM F963-16 para la seguridad de los juguetes.

On October 7, 2016, the Office of Administrative Law (OAL) approved the emergency regulation proposed by the California Office of Environmental Health Hazard Assessment (OEHHA) regarding temporary use of a standard point-of-sale warning message for Bisphenol A (BPA) for canned and bottled foods and beverages.

The emergency regulation continues the adoption of a standard point-of-sale warning message for BPA for canned and bottled foods and beverages addressed in the previous amendment on California Code of Regulations (See test). The emergency regulation will expire on January 18, 2017.

In addition, OEHHA initiated a regular rulemaking process for BPA warnings (See test) but the rulemaking procedure has not been completed yet.

On October 21, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) added a new chemical to the Proposition 65 List. The new chemical is: 1. Pentachlorophenol and by-products of its synthesis (complex mixture)

The added chemical meets the requirements for listing as known to the State of California to cause cancer for purposes of Proposition 65. The chemical details are provided below:

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

Recent 60-day notices from September and October of 2016 include the following:

On October 12, 2016, the Maine Department of Environmental Protection (DEP) issued a draft rule to designate two chemicals of high concern as priority chemicals. The two chemicals are Decabromodiphenyl Ether (Deca BDE) and Hexabromocylododecane (HBCD).

According to the Maine Toxic Chemicals in Children’s Products Law, manufacturers of children’s products are required to submit a report to DEP within 180 days after a priority chemical is newly identified if the product contains:

1. A priority chemical that is intentionally added to a component of children’s product at concentration above the Practical Quantification Limit (PQL); or

2. A priority chemical that is a contaminant present in a component of children’s product at a concentration above 100 ppm

In the draft rule, the following products are exempted from the reporting requirements:

1. Used products

2. Food and beverage packaging (except for product intended for use by children under 2 years old)

3. Transportation, such as motor vehicles and watercraft (except detachable car seats)

The draft rule was under comment period until November 14, 2016.

In October 2016, the Vermont Department of Health (DOH) issued an updated Guidance for Manufacturers: Chemical Disclosure Program. The guidance provides supporting information for the chemicals of high concern to children (CHCC) rule.

The key changes in the updated guidance are summarized as follows:

1. Updated the type of product information that is required to be reported:

   1. Manufacturers will download an Excel template, which will be used to submit brand name and product model data.

   2. If a product is offered for sale in different sizes or variations, the individual variations may need to be reported separately if the concentration of the chemical within the component is significantly different.

   3. If a specific item that contains one of the 66 chemicals is sold in multiple toy sets (for example, one screw driver is sold as part of three different children’s toy construction sets) the disclosure would include the following:

      1. The chemical used in the screw driver

      2. The Product Model/Brand Name Excel form upload containing all product model and brand names that use the screw driver (as well as any other product models and brand names that use the chemical being reported)

      3. The details about the screw driver (function of chemical, component, concentration of chemical, brick)

2. Added a guideline for manufacturers to report chemicals that are trade secret

3. Clarified that there is no additional waiver for small business or manufacturers

4. Clarified that there is not a phased-in schedule for reporting

5. Added a new section for payment information

In the US, when hazards are identified in consumer products, they will be recalled and published in the Consumer Product Safety Commission (CPSC) Recent Recalls on the CPSC website, which is updated daily. The US recalls from September 1 to October 30, 2016 are summarized below:

* Other Hazards include Burn Hazard, Choking Hazard, Electrical shock Hazard, Entanglement Hazard, Failure to Operate in an Emergency, Ingestion Hazard, Laceration Hazard, Microbial Hazard, Strangulation Hazard and Violation of Federal Flammability Standard with frequency less than 4.

^ Other Categories include Art Materials, Fabric / Textile / Garment / Home Textile, Footwear, Heating / Cooling

Download the complete Recalls Summary - US (October 2016)

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 September 1 to October 30, 2016 are summarized below:

* Other hazards include Burn Hazard, Chemical Hazard, Drowning Hazard, Impact Hazard, Electric Shock Hazard, Entrapment Hazard, Laceration Hazard, Microbial Hazard, Strangulation Hazard and Violation of Packaging and Labeling Requirements with a frequency of less than 5.

^ Other categories include Computer / audio / video / other electronics & accessories, Cosmetics / Bodycare, Footwear, Furniture, Home electrical appliances (hair dryer, iron, etc.), Homeware (non-food contact), Lighting, Tools and Hardware and Toys and Childcare Articles with frequency less than 4.

Download the complete Recalls Summary - Canada (October 2016)

On October 6, 2016, the European Chemical Agency (ECHA) proposed to amend Annex XVII of Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through World Trade Organization (WTO) notifications. The added chemicals are Methanol and Perfluorooctanoic acid (PFOA).

Upon enforcement, the proposed regulations will amend the Annex XVII of REACH Regulation List of Restriction by adding following 2 chemicals and their conditions:

On October 4, 2016, the Turkey Ministry of Customs and Commerce issued new Toy Safety Regulations (Number 29847). The regulations determine the procedures and principles for the importation of safe toys which are intended or designed for use in game play for children under 14 years of age.

The Turkey Toy Safety Regulations adopt the European Toys Safety Directive 2009/48/EC and it will become effective on April 4, 2017. The new regulations address certain requirements for toys:

1. EC Declaration of Conformity

2. “CE” Mark

3. Conformity assessment requirement including physical and mechanical, flammability, chemical and electrical requirements

4. Technical documentation

5. Standards showing presumption of conformity

This regulation does not apply to the following toys:

1. Playground equipment

2. Automatic coin-operated gaming machines

3. Combustion engines for toy vehicles

4. Toy steam engines

5. Slings and catapults

On October 13, 2016, the Ministry of Industry and Information Technology of the People’s Republic of China (MIIT) proposed an amendment of standard SJ/T 11364-2014 Marking for the Restriction of Hazardous Substances in Electrical and Electronic Products. The standard details labeling and marking requirements for products covered by the China Restriction of the Use of Hazardous Substances in Electrical and Electronic Product (China RoHS 2).

The proposed amendments add new conditions for electronic and electrical products that may not be required to have markings directly on the product such as components, parts and raw materials. (Examples: display components, circuit boards, resistors, etc.) However, the marking is still required on the product instructions. The amendment was under comment period until November 13, 2016.

On July 21, 2016, Senate bill 838 was introduced in the 17th Congress of Senate of the Philippines. The bill proposes an amendment to the Republic Act No. 7394 Consumer Act of the Philippines including Chapter IV Labeling and Fair Packaging.

Key proposed amendments of the regulation related to labeling information on consumer products are summarized below:

• Consumer products with product labels written in a foreign language shall have a corresponding English or Pilipino translation to allow better understanding of the product contents, features and uses

• A new provision is added to ban suppliers from importing defective goods

• The requirements for consumer products with specific claims are further strengthened by the ingredient list requirement. A specific claim can appear only when the ingredient’s quantities and properties as well as the material benefit that results from its inclusion in the product formulation have been technically substantiated.

In addition to changes in labeling requirements, the amendment also adds a new provision to ban suppliers from importing defective goods.

El 9 de septiembre de 2016, el Ministerio de Comercio, Industria y Energía de Corea (MOTIE) publicó la Notificación 2016-481 a través de la Organización Mundial del Comercio (OMC ) para proponer revisiones de las normas de seguridad de los productos infantiles contemplados en el artículo 22 de la Ley Especial sobre Seguridad de los Productos Infantiles.

A continuación se resumen las principales modificaciones propuestas:

• Se aclaran los tipos de juguetes que entran en el ámbito de aplicación y los productos exentos

• Refuerza los requisitos de seguridad, etiquetado y manual de usuario de los juguetes eléctricos para montar (modelado de la norma ASTM)

• Refuerza los requisitos de seguridad de las sustancias químicas peligrosas y modifica en consecuencia los métodos de ensayo (modelización de la norma EN-71, parte 3, sobre migración de 19 elementos de metales pesados).

• Añade el fosfato de tris(2-cloro-1-metiletilo) (TCPP) y el fosfato de tris(1,3-dicloro-2-propilo) (TDCP) a los requisitos sobre productos químicos ignífugos.

• Se añaden requisitos microbianos para los juguetes que contienen líquidos