March 2019 Regulatory Update

The added chemicals meet the requirements for listing under the Proposition 65 law as known to the State of California to cause cancer. The chemical details are provided below:

Eyewear included in this SUD are prescription glasses, over-the-counter (OTC) reading glasses, non-prescription sunglasses, and safety glasses. If confirmed, the specified eyewear would not require a Prop 65 warning statement for BPA as it will have been determined that exposure to BPA in the specified eyewear does not present significant risk of birth defects or reproduction harm. Exposure to other Prop 65 listed substances in eyewear may still require a Prop 65 warning.

The SUD is currently in a 30-day public comment period. If you manufacture, distribute or sell the specified eyewear, or are otherwise an interested party, written comments should be submitted to OEHHA by April 8, 2019.

The proposal refined the requirement for the disclosure and reporting of toxic substances that are intentionally added to children's products. Twenty new chemicals have been proposed to be added based on this new proposal. Manufacturers of children's products will be required to report the presence of chemicals once the proposed rule becomes effective.

The proposed amendment was under a comment period through February 8, 2019.

According to the proposed bill, the following flame retardants are subject to the prohibition in furniture and juvenile products after January 01, 2020 if they are at a concentration level above 1000 ppm:

• Halogenated, organophosphorous, organonitrogen, or nanoscale flame retardant chemical
• The penta- or octa- polybrominated diphenyl ethers, the deca- polybrominated diphenyl ethers (PBDEs), or decabromodiphenyl ether
• Antimony
• A chemical defined as a “designated chemical” under Section 105440 of the California Health and Safety Code;
• A chemical listed on the Washington State Department of Ecology's list of Chemicals of High Concern to Children, and identified as a flame retardant or as a synergist to flame retardants in the rationale for inclusion in the list.

All covered products are required to have a label affixed to declare the presence or absence of the flame retardants as per the following:

• “The materials in this product contain [or do not contain] added flame retardant chemicals.”

A public consultation was scheduled on February 12, 2019 to receive comments on the bill.

For the complete list click here

In order to address the flammability risks of tents available to consumers, Health Canada is considering replacing the current flammability and labelling requirements of tents with a new National Standard of Canada titled CAN/CGSB-182.1, Flammability and Labelling Requirements for Tents. Play tents are currently excluded from the scope of CAN/CGSB-182.1, but new requirements for these products are proposed to be added into the Toys Regulations.

The proposed amendment is under a comment period through March 23, 2019.

The Canada Regulation SOR/2018-196 was published in October 2018 to regulate the manufacture, import, sale and use of processed asbestos fibres and consumer products containing asbestos. (See Regulatory Recap: December 2018). According to the regulation, consumer products containing asbestos in greater than trace amounts are prohibited.

In the guidance document, asbestos is defined as:

• Actinolite
• Anthophyllite
• Amosite
• Chrysotile
• Crocidolite
• Tremolite

The presence of asbestos in more than a trace amount can be demonstrated by test results identifying asbestos at 0.1% or more and having both of the following characteristics:

1. Fibres longer than 5 µm, with a mean aspect ratio greater than 3:1. Aspect ratios should be determined for fibres, not bundles; and
2. Very thin fibrils, less than 3 µm in width

In order to reduce the regulatory burdens, manufacturers, renovators, and home hobby/craft operators of bedding and other upholstered or stuffed articles will no longer be required to register in Manitoba or meet the label standards starting January 1, 2020. The Consumer Protection Office will continue to administer the legislation until the revocation.

It is important to note that upholstered and stuffed articles destined for sale in Quebec are still required to fulfill the necessary labeling requirements in the province.

According to the proposed amendment, migration limits of Aluminum were reduced as below:

In the proposed amendment, 3 levels of restriction for formaldehyde were established for toys intended for use by children under 36 months or in other toys intended to be placed in the mouth:

The details for the 6 proposed SVHCs to be added to the List of Authorisation are listed below:

Under the amendment, 3 new substances are approved and may be used in the manufacturing of food contact materials.

• Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (CAS 147398-31-0)
• Dimethyl carbonate (CAS 616-38-6)
• Isobutane (CAS 75-28-5)

In addition, other changes included:

• Modifying the specific migration limits and
• Modifying the usage condition of specific listed substances
• Clarifying the selection criterion of food simulants condition for overall migration:

The amendment came into force on January 31, 2019.

RoHS is a directive regulating the manufacture, import and distribution of Electronics and Electrical Equipment (EEE) within the EU. It bans the use of 6 chemical substances, including Lead, Mercury, Cadmium, Hexavalent Chromium, Polybrominated Biphenyls, and Polybrominated Diphenyl Ether.

In the new RoHS directive (RoHS 3), the requirements expand the scope of monitoring to 10 chemical substances with the addition of 4 phthalates (DEHP, BBP, DBP and DIBP), which are primarily used as plasticisers to soften plastics. Details as below:

The new restriction on all EEE will enter into force on July 22, 2019.

ISO 8124-6 is an international standard for the determination of certain phthalate substances present in toys and children’s products made of plastic, textile, coatings and liquid. Below is a summary of the key revisions in the updated version of the standard:

• Addition of diisobutyl phthalate (DIBP). Total number of phthalates specified in the standard increases from 6 to 7 (DIBP, DBP, BBP, DEHP, DNOP, DINP and DIDP)
• Inclusion of liquid material in toys and children’s products in the scope of standard
• Introduction of ultrasonic bath method

The CCC system is mandatory for all products specified in the catalogue, including certain types of toys. A CCC certificate is required to be granted and a CCC mark must be affixed to each product being imported, sold or used.

• The following products are removed from the CCC Product list

• The following products were changed from compulsory certification to self-declaration procedure.

The standard provides safety requirements, testing specifications, markings and instructions for the use of portable power banks and any portable energy-storage device containing secondary batteries. In addition, external Thai Industrial Standards TIS 2217 and TIS 1561 are also applied to ensure compliance with the security requirements of portable power banks.

The new safety standard came into force on January, 09, 2019.

The first implemented TR is for Gas appliances and their accessories, which was implemented in January 2019. Specific TRs have not been implemented on SABER yet for other products that are regulated by any TR. Certificates of Conformity (CoC) shall be issued through the existing CoC program. For all other non-regulated products, self-declaration according to the approved forms by SASO is sufficient, and shall be applied through the SABER system.

On April 1, 2019, the following regulations will be enforced and implemented on SABER as well:

1. Gulf Technical Regulations for Low Voltage Electrical Equipment and Appliances
2. Gulf Technical Regulations for Children’s Toys
3. Technical Regulations for Lubricating Oil

Products falling within the scope of the above TR will be required to be registered through the SABER system for acquiring a CoC. (See Regulatory Recap: December 2018)