January 2021 Regulatory Update

In 2016, new Article 6 Clear and Reasonable Warning regulations were adopted by OEHHA which included provisions for a short-form Prop 65 warning. However, as less label space was required and the identification of a specific Prop 65 listed chemical could be avoided, the short-form could be utilized in ways that went against the intention and purpose.

Since less information is provided to the consumer by the short-form warning, the January 8 proposal would restrict its use by suggesting various changes, including:

• Limiting the use of the short-form warning for consumer information to products with 5 square inches or less of label space available (and where the package shape or size cannot accommodate the full-length warning). The requirement of type size of the warning remains unchanged (i.e., type size no smaller than “the largest type size used for other consumer information on the product” and no smaller than 6-point type)
• Requiring identification of at least one Prop 65 listed chemical in the warning for which the warning is being provided
• Prohibiting the short-form warning listed for internet purchases and catalog purchases even when the warning provided on the product itself is in compliance with the regulation
• Including the words “Risk” and “Exposure” in the warning
• Clarifying the use of short-form warnings for food including the use of an offset boxed warning
• A short-form warning for exposures to chemicals in food is not clearly allowed in the current regulation. OEHHA has therefore proposed a new short-form warning be included for food of which the language is very similar to the one for other products.

Under the proposal, the new warning would be more detailed, providing more information.

Below is an example warning statement when the product requires a warning from both toxicity endpoints (carcinogen and reproductive toxicant):

“WARNING: Cancer Risk from [insert chemical name] and Reproductive Risk from [insert chemical name] Exposure – www.P65Warnings.ca.gov.”

The proposed amendments will be subject to a public written comment period that runs until March 8, 2021. A web-based public hearing will be scheduled, only upon request. Considering a strong opposition from the business community, OEHHA has proposed that the regulation become operative one year after the effective date of the amendments. Any products that are manufactured within that one-year window and that carry the current short-form warning may be sold through indefinitely. As a result, the new regulations would not apply to products manufactured prior to the enforcement date of the regulations.

The upholstered furniture flammability legislation was sponsored by Senator Roger Wicker (R-MS) and renamed the COVID-19 Regulatory Relief and Work from Home Safety Act (S.1341). It requires the U.S. Consumer Product Safety Commission (CPSC) to adopt California’s Technical Bulletin 117-2013 as a federal flammability standard for residential upholstered furniture.

California TB 117-2013 outlines performance standards and methods for testing the smolder resistance of cover fabrics along with the barrier, filling and decking materials used in upholstered home furnishings. The American Home Furnishings Alliance (AHFA) formally petitioned the CPSC to adopt the measure as a national standard in October 2015 and later introduced SOFFA when no action from the agency was forthcoming. The legislation advanced in the House in both 2017 and 2019 but remained stalled in the Senate.

All upholstered seating furniture imported or sold in the United States must comply with the flammability test specified by California Technical Bulletin TB117-2013. In addition to the labeling requirements required from the California TB 117-2013 standard, each item of upholstered furniture is required to bear the statement, “Complies with the U.S. CPSC requirements for upholstered furniture flammability” on a permanent label located on the product after June 25, 2021.

The CPSC is proposing to amend its Standard for the Flammability of Mattresses and Mattress Pads. The ignition source cigarette specified in the standard for use in the mattress standard’s performance tests, Standard Reference Material cigarette, SRM 1196, is no longer available for purchase.

The Commission is proposing to amend the mattress standard to require a revised Standard Reference Material cigarette, SRM 1196a, which was developed by the National Institute of Standards and Technology, as the ignition source for testing to the mattress standard.

The notice of proposed rulemaking (NPR) categorizes crib mattresses as products designed to be used with infant sleep products, such as full-size cribs, non-full-size cribs, bassinets and cradles, and play yards, to provide sleeping accommodations for an infant. As specified in the NPR, the proposed rule will cover:

• Full-size crib mattresses
• Non-full-size crib mattresses
• After-market mattresses for play yards

The CPSC’s notice of proposed rulemaking discusses the incident data and hazard patterns identified by the staff. Common product-related hazard patterns identified include chemical/ flammability hazards, softness, etc., but the identified hazard categories associated with fatalities are:

• Crib mattress use in play yard
• Face in mattress
• Child found prone
• Fit issues
• Cases of multiple contributing factors

ASTM F2933 is the voluntary industry standard addressing crib mattresses. The CPSC staff’s review of current standard ASTM F2933-19 has deemed it to be insufficient in addressing the hazard patterns identified by the incident data and requirements for labeling, while noting that the ASTM subcommittee is in the process of reviewing the standard to address these issues but has met with delays due to the COVID-19 pandemic.

Key modifications proposed by the NPR to the ASTM F2933 standard include:

• Adding a coil springs impact test ensuring there are no exposed coil springs after testing for 1000 cycles
• Adding a mattress firmness test modeled on the Australian/ New Zealand standard AS/ NZS 8811.1 to measure surface softness
• Modification of the mattress size measurement test to include a fitted sheet to better account for mattress compression by the fitted sheet
• Revisions to the non-full-size crib mattress measurements and requirements to include after-market mattresses
• Revisions to safety warning requirements and examples on product and in the instructional literature

Additionally, the CPSC is proposing to amend 16 CFR 1130 durable nursery products consumer registration requirements to include crib mattresses within the scope and is proposing to amend 16 CFR 1112 certification requirements to also include such crib mattresses.

Summary of Standards:

*Other Hazards include Drowning Hazard, Electric Shock Hazard, Fall Hazard, Entrapment Hazard with a frequency of less than 7.

^Other Categories include Cosmetics, Eyewear, Fabric / Textile / Garment / Home Textile, Food Contact Material, Footwear, Personal Protective Equipment with a frequency of less than 6.

For a complete list click here

The two Directives, (EU) 2020/2088 and (EU) 2020/2089, update the lists under Point 11 of Part III in Annex II of the Toy Safety Directive (TSD). These lists are:

1. ‘Prohibited List’ – contains 55 allergenic fragrances. Their presence is allowed if it is technically unavoidable under good manufacturing practice (GMP) and each fragrance is no more than 100 mg/kg. These substances should not be used intentionally
2. ‘Labelling List’ – contains 11 allergenic fragrances. These require their name to be listed on the toy, on an affixed label, on the packaging, or in the accompanying leaflet if their concentrations are greater than 100 mg/kg

Summary of the Amendment

List of allergenic fragrances which require labelling has been extended (from 11 to 71 allergenic fragrances)

1. Added 61 allergenic fragrances
2. Added 2 CAS no. to Citronellol (1117-61-9 and 7540-51-4)
3. Removed methyl heptane carbonate (111-12-6), as it becomes a prohibited allergenic fragrance

List of prohibited allergenic fragrances has been extended (from 55 to 58 allergenic fragrances)

1. Added 3 allergenic fragrances

One of the amendments made by the new regulation is an update to Appendix 10 to Annex XVII to Regulation (EC) No 1907/2006, listing testing methods for azo colorants for the purposes of entry 43 of the Annex. The testing methods are outdated and have been replaced with more up-to-date testing methods by the European Committee for Standardization. Appendix 10 is updated accordingly to express those changes. The updated harmonized standards are EN ISO 17234-1:2015, EN ISO 14362-1:2017 and EN ISO 14362-3:2017 which supersede EN ISO 17234-1:2010, EN 14362-1:2012 and EN 14362-3:2012, respectively (see below Table 1).

Table 1

There is another amendment removing Pentachlorophenol (PCP) and its salt, Decabromodiphenyl ether (DecaBDE) and Perfluorooctanoic acid (PFOA) and its salts from the Annex, as the substances are restricted more severely under Regulation (EU) 2019/1021 on persistent organic pollutants (POP Recast Regulation, consolidated to Sep 2020). Stakeholders should be aware to take appropriate measures to comply with the restriction introduced by Regulation (EU) 2019/1021 regarding those substances (highlights are summarized in below Table 2).

Table 2

The major changes are listed below:

1. Adds a definition for disguise costumes
2. Adds a new requirement for disguise costumes - the test specimen is to be tested before and after washing, even if the instructions state not to wash
3. Increases the testing of smaller specimens by allowing combined or half-size specimens
4. Adds clarifications on the measurement of unhindered dimensions, and of test categories applicable to toys worn on the head and to toy disguise costumes
5. Adds an annex of a guidance on how to determine the appropriate test requirement of the product
6. Adds an annex on suggestions to manufacturers on how to reduce the rate of spread of flames for toy disguise costumes
7. Adds an annex of flowcharts showing how to obtain test specimens from toy disguise costumes
8. Adds definition of toys intended to be entered by a child (constructed from fabric and/or polymer sheets and films that are intended to fully or almost fully enclose a child on all sides)

The standard still needs to be harmonized. This means that it needs to be accepted by the EU Commission and Member States by publication in the Official Journal of the EU (OJEU). Only then can it be used to show compliance to the EU Toy Directive 2009/48/EC.

Substances added to the Candidate List for authorization on January 19, 2021 are as follows:

The summary below consolidates the published references of standards. It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn.

GB/T 39508-2020 is applicable to infant and children's clothing mainly made of knitted fabrics. The requirements of this standard are divided into internal quality (quality after performance testing) and appearance quality (quality upon initial visual inspection).

Internal quality includes characteristics such as, but not limited to:

• fiber content,
• formaldehyde content,
• pH value,
• odor,
• forbidden carcinogenic aromatic amine dyes,
• bursting strength, pilling, dimensional change rate after washing,
• dimensional change rate after dry cleaning,
• distortion rate after washing,
• color fastness to saliva, water, perspiration, soaping, rubbing, dry cleaning, light, perspiration, bleeding,
• moisture permeability,
• tensile strength, etc.

Appearance quality includes:

• defects,
• size deviation,
• size difference of symmetrical parts,
• sewing irregularities,
• raw material index.