February 2017 Regulatory Update

In the final rule, the ASTM F2907-15 Standard Consumer Safety Specification for Sling Carriers is adopted. A sling carrier is defined in the standard as a product of fabric or sewn fabric construction which is designed to contain a child in an upright or reclined position while supported by the caregiver’s torso. The standard’s requirements apply to all slings and the CPSC has also identified the following 3 types of sling carrier products available in the United States:

1. Ring slings (hammock-shaped fabric products in which one runs fabric through two rings to adjust and tighten the sling)
2. Pouch slings (similar to ring slings but do not use rings for adjustment)
3. Wrap slings (composed of a long length of fabric, up to 6 yards long and 2 feet wide, with no fasteners)

The final rule will be effective January 30, 2018

On October 20, 2016, a new version of the ASTM F963 toy safety standard was published. The revision contains clarifications, corrections and new requirements. In general, certain changes in the requirements are revised to be more aligned with other standards including EN 71-1 and ISO 8124-1. (See Overview of changes in ASTM F963-16 Toy Safety Standard for detail.)

Recently, the CPSC issued the Direct Final Rule to confirm adoption of the updated standard. In the rule, 16 CFR 1112 was amended to include that specified sections of ASTM F963-16 are required to be subject to third party testing and, therefore, the CPSC only accepts accredited third party conformity assessment bodies for testing to those sections. Apart from that amendment, 16 CFR 1250 was added to the Code of Federal Regulations to address that toys must comply with the provisions of ASTM F963-16. This addition to the rule clarifies requirements so that the public may more easily understand the mandatory rules that apply to toys.

The effective date of the direct final rule to adopt the updated toy safety standard is April 30, 2017, unless significant adverse comments are received by March 6, 2017.

DCM is a volatile chemical while NMP is a solvent. Both chemicals have a variety of uses, including commercial paint and coating removal. However, the EPA has identified risks associated with the use of DCM and NMP and, therefore, proposed regulations under the Toxic Substances Control Act (TSCA) as summarized below:

For both NMP and DCM:

1. Prohibits the manufacture (including import), processing and distribution in commerce of DCM/NMP for consumer and most types of commercial paint and coating removal
2. Prohibits the use of DCM/NMP in commercial paint and coating removal
3. Requires manufacturers (including importers), processors and distributors of DCM/NMP for any use to provide downstream notification of these prohibitions throughout the supply chain and requires recordkeeping. This does not apply to retailers.

Based on various surveys and exposure assessments conducted by the FDA on cosmetic lip products and externally applied cosmetics, it was concluded in the guidance document that a maximum level of 10 ppm lead as an impurity would not pose a health risk. The recommended level of lead is consistent with other public health authorities including Health Canada and the European Directorate General for Enterprise and Industry.

This guidance does not establish legally enforceable limits, but should be viewed as recommendations by the FDA. The FDA maintains that these levels should be attainable following good manufacturing practices and responsible ingredient sourcing. The guidance document does not apply to topically applied products classified as drugs or to hair dyes that contain lead acetate as an ingredient.

Food contact substances covered by this guidance include, but are not limited to, the following:

1. Infant formula packaging for both liquid and powdered formula
2. Baby bottles
3. Bottle inserts
4. Nipples

In the guidance, recommendations are provided regarding how the scientific information in FCNs for infant food uses should demonstrate that the food contact substance is safe for the specific intended use. There are three categories of recommendations provided in the guidance:

1. Chemistry recommendation
2. Toxicology recommendation
3. Administrative recommendation

The comment period for the draft guidance closed on February 7, 2017.

In the revised advisory, labeling recommendations are provided and the key information required is summarized in the below table:

Remark:

1. No TPC number is required if the products are exempt from third party certification following approval by CARB based on the use of no-added formaldehyde (NAF) and certain ultra-low-emitting formaldehyde (ULEF) resins.

The key revisions to the proposed regulations are summarized below:

1. Clarified the definition of children’s foam-padded sleeping products containing TDCPP or TCEP as being assembled products designed or intended primarily for children 12 years of age or younger to nap or sleep on.
2. Mattresses, mattress pads and mattress sets regulated by 16 CFR 1632 and 1633 are now exempted
3. Other editorial changes are included

The comment period for the revised text was closed on January 12, 2017.

The detail of the three phases are summarized below:

In phase 2, the OHA published the final text of the rules which includes:

1. Practical Quantification Limits (PQL) established for each high priority chemical
2. Definition of ”Product Category” as “brick” level of the GS 1 Global Product Classification (GPC) standard, which identifies products that serve a common purpose, are of a similar form and material, and share the same set of category attributes.
3. Details of the information required for reporting
4. The reporting schedule:
1. No later than January 1, 2018, and every other year thereafter, a children’s product manufacturer shall provide notification if the product contains listed priority chemicals in an amount above the PQL or concentration of 100 ppm. (First notification applies to children’s product sold or offered for sale between January 1, 2017 and December 31, 2017.)
2. Future notices apply to children’s product sold or offered for sale during the previous two year period.
3. The second biennial notice will cover the period of January 1, 2018 to December 31, 2020.
5. Exemptions from reporting requirements

According to the notice, the Canada DOE and DOH are initiating the proposal of regulations to prohibit all future activities regarding asbestos and asbestos containing products, including the manufacture, use, sale, offer for sale, import and export. The proposed regulations are intended to be published in the Canada Gazette, Part I, in December 2017. Currently, no regulatory detail has been provided.

The reporting obligations are retrospective, applicable to calendar years 2014 and 2015, and the reporting deadline is July 17, 2017. According to the guidance, the reporting applies to those who, during either the 2014 or 2015 calendar year, met any of the following criterion:

1. Manufactured a total quantity more than 100 kg of a listed substance (Part 4 of the list is applied to a substance that is intended to be part of a cosmetic, food, therapeutic product or natural health product under Food and Drugs Act);
2. Imported a total quantity more than 100 kg of a listed substance that is:
1. Alone, or
2. At a concentration more than or equal to 0.1% by weight (w/w%) in a mixture or in a product;
3. Imported a total quantity greater than 100 kg of a listed substance(Part 4) that is contained in or intended to be part of a cosmetic , food, therapeutic product or a natural health product under Food and Drugs Act

The chemicals added are:

1. 4,4'-isopropylidenediphenol (Bisphenol A, BPA) (EC No. 201-245-8, CAS No. 80-05-7)
2. 4-heptylphenol, branched and linear
3. Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts
4. p-(1,1-dimethylpropyl)phenol

The deadline for notification about the presence of the new SVHCs in articles is July 12, 2017, six months after their inclusion on the List.

Upon enforcement, the proposed regulations will amend Annex XVII of REACH Regulation List of Restriction by adding following substances:

1. Tetrahydro-2-furyl-methanol
2. Gallium arsenide
3. Tributyltin compounds
4. [1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear]
5. 1,2-dichloropropane
6. Bisphenol A
7. [phenol, dodecyl-, branched], [phenol, 2-dodecyl-, branched], [phenol, 3-dodecyl-, branched], [phenol, 4-dodecyl-, branched], [phenol, (tetrapropenyl) derivatives]
8. Chlorophacinone (ISO)
9. Warfarin (ISO)
10. Coumatetralyl (ISO)
11. Difenacoum (ISO)
12. Brodifacoum (ISO)
13. Flocoumafen (ISO)
14. Disodium octaborate anhydrous
15. [e-glass microfibers of representative composition]
16. Lead powder and lead massive
17. Bromadiolone (ISO)
18. Difethialone, [perfluorononan-1-oic acid, and its sodium and ammonium salts]
19. Dicyclohexyl phthalate
20. 3,7-dimethylocta-2,6-dienenitrile
21. Triflumizole (ISO)

The 3 harmonised standards are summarized below:

* Other Hazards include Asphyxiation Hazard, Burn Hazard, Damage to Hearing Hazard, Entrapment Hazard, Environmental Hazard, Fall Hazard, Laceration Hazard and Microbial Hazard with a frequency of less than 10.

# Other Categories include Candles & Burning Items and Accessories, Cosmetics / Bodycare, Footwear, Homeware (Non-food Contact), Jewelry, Watch or other Fashion Accessories, Personal Protective Equipment (excludes eye protection), Sporting Goods / Equipment and Tools and Hardware with frequency less than 8.

Download the complete Recalls Summary - EU (December 2016 and January 2017)

Ethanol burners are small, portable, decorative alcohol-fueled burners and they have already led to a number of serious and life-threatening injuries. Therefore, the interim ban does not allow retailers to sell decorative alcohol-fueled burners in the Australian Capital Territory, except if they:

• Have a power output of more than 4.5 kW, orRequire installation in a fixed position, or
• Require installation in a fixed position, or
• Are designed for warming food

Additionally, the interim ban is effective immediately when the ACCC publishes the notice. Retailers and suppliers are required to stop selling and remove portable ethanol burners from store shelves and online stores.