March 2021 Regulatory Update

The standard was primarily established in response to the global COVID-19 pandemic beginning in 2019 to address a product that is neither a medical face mask per ASTM Specification F2100 for providing source control, nor a respirator for providing inhalation protection as defined by regulatory requirements specified in the United States under 42 CFR Part 84.

The focus of this specification is to identify how the non-medical barrier face covering should perform in terms of source control/protection, comfort, and re-use potential. The level of source control/protection depends on how well particles are blocked from going through the barrier face covering and minimizing the amount of leakage that may occur around the perimeter of the barrier face covering.

Following are the key requirements established by the standard:

• Performance Requirements

• Performance Property	Level 1 (Lower performance)	Level 2 (Higher performance)
  Sub-micron particulate filtration efficiency	≥ 20%	≥ 50%
  Airflow resistance, inhalation	≤ 15 mm H2O	≤ 5 mm H2O

• Note – Each performance property can be classified into two levels where level 1 is the minimum acceptable level
• Design Requirements – take into account the general construction of the barrier face coverings such as, the materials shall be non-irritating and non-toxic, free of sharp edges, sharp points or burrs, includes a retention system to keep on wearer’s nose / mouth, etc.
• Conformity Assessment – follows Guide F3050-17 Annex A3 Model A to issue a declaration of conformity indicating that each barrier face covering labelled as compliant has met all of the requirements of this standard specification including design criteria, performance criteria, test methods, labelling, and user information. Additionally, conformance to this standard requires that sub-micron particulate filtration efficiency and airflow resistance tests have been performed by a laboratory accredited for conducting these tests.
• Product and Packaging Labeling & User Instructions – specifies the minimum content for labels that appear on the barrier face covering, its immediate packaging, and if different, point-of-sale packaging. User instructions to guide selection and sizing, proper use (positioning and adjustment), and care including cleaning or laundering if product reuse is intended, informs on product cautions and limitations, and describes product replacement and disposal procedures.

The Source Reduction Council of the Coalition of Northeast Governors (CONEG) developed the Model Toxics in Packaging Legislation in 1989 to reduce the amount of heavy metals in packaging and packaging components that are sold or distributed throughout the United States. The intent was to curb the amount of heavy metals – specifically, lead, mercury, cadmium, and hexavalent chromium ─ entering the municipal solid waste stream and, ultimately, landfills, incinerators, and recycling streams from packaging, since packaging comprises approximately one-third of the waste stream. TPCH was formed in 1992 to promote the Model Legislation and consistency in its implementation across states that adopted the Model Legislation. To date, the Model has been adopted by nineteen U.S. states, including: California, Connecticut, Florida, Georgia, Illinois, Iowa, Maryland, Maine, Minnesota, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin.

On February 16, 2021, the Toxics in Packaging Clearinghouse (TPCH) announced the organization’s 2021 update to their Model Toxics in Packaging Legislation.

Major changes include:

• Prohibiting intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS).
• Restricting intentionally added ortho-phthalates (commonly known as phthalates) to no more than 100 ppm (0.01%).
• Removing some of the current exemptions such as for vitrified labels and recycled materials.

The updated Model Legislation became effective on February 16, 2021 and it will be up to each state to adopt changes to their existing laws or adopt a new law to address toxics in packaging.

In 2018, the Washington State Legislature passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in “specific food packaging applications” if safer alternatives are available (recodified as RCW 70A.222.070). This law requires the Washington State Department of Ecology (DoE) to conduct an alternatives assessment to evaluate “less toxic chemicals and nonchemical alternatives” and determine whether safer alternatives are available. This law defines “food packaging” as “a package or packaging component that is intended for direct food contact and is comprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibres.”

According to the law, the prohibition on the use of PFAS chemicals in food packaging:

• Becomes effective January 1, 2022, if safer alternatives were identified by January 2020.
• Does not take effect January 1, 2022, if safer alternatives were not identified by January 2020.

If the DoE does not find that a safer alternative is available for some or all categories of food packaging applications, beginning January 1, 2021, and each year following, the DoE must review and report on alternatives. The prohibition on PFAS for specific food packaging applications takes effect two years after a report submitted to the legislature finds that safer alternatives are available. In February 2021, the DoE released its first alternatives assessment report for PFAS in food packaging. The report found that PFAS alternatives (shown in parentheses) are available for the following four packaging applications:

• Food boats (clay-coated and reusable options)
• Plates (clay-coated and reusable options)
• Pizza boxes (uncoated options)
• Wraps and liners (wax-coated options)

Based on the availability of safer alternatives, per- and polyfluoroalkyl substances (PFAS) in the above four types of food packaging will be banned as of February 2023.

However, in the following food packaging applications, DoE did not identify any alternatives that met the criteria for safer without restrictions at this time:

• Bags and sleeves
• Bowls
• Trays
• French fry cartons
• Clamshells
• Interlocking folded containers

DoE will continue with the alternatives assessment process for these six products, as well as other potential products.

ASTM F3492-21 covers safety requirements, chemical requirements, performance requirements, and warnings for child safety locks and latches intended to be installed by consumers to the interior of residential cabinet doors and drawers to restrict access to household cabinets by children under the age of 48 months.

The key requirements include:

• No accessible hazardous sharp points or edges (as defined in 16 CFR 1500.48 & 16 CFR 1500.49
• No small parts (as defined in 16 CFR 1501)
• A magnetic requirement
• Total Lead requirements on all paint and surface coatings (as defined in 16 CFR 1303)
• Openings requirements
• Effective strength requirements
• Marking and labeling requirements
• Instructions

The child safety locks and latches that are not covered by this standard include those:

• Installed on the exterior of a cabinet door or drawer
• Requiring installation by professionals, or
• That are an integral part of the cabinet door or drawer system
• Child safety locks, latches and straps intended for use on furniture or appliances as anchoring devices to prevent tip over

In January 2021, the U.S. Environmental Protection Agency (EPA) published five final rules in the federal register (86 FR 866-932) to regulate five persistent, bioaccumulative and toxic (PBT) chemicals under Section 6(h) of the Toxic Substances Control Act (TSCA). These final rules became effective on February 5, 2021 with some restrictions commencing on March 8, 2021.

However, on the same day of the effective date for starting the restrictions, the EPA is asking for additional public input, including an additional 60-day comment period for the five PBT chemicals and a temporary 180-day “No Action Assurance” for PIP (3:1), in accordance with Biden-Harris Administration executive orders and directives since these rules are intended to provide critical health protections for Americans, including children, workers, other potentially at-risk groups, and the environment. Re-examining these rules will ensure the promise from the U.S .government to protect human health and the environment by reducing exposure to toxic chemicals can be delivered.

These five PBT chemicals are:

The toy safety standard originated in Australia as part of AS 1647-1974 and later has been jointly revised and redesignated as AS/NZS ISO 8124.3. The new version AS/NZS ISO 8124.3:2021 identically adopts ISO 8124-3:2020, which was published in March 2020 and specifies maximum acceptable levels and methods of sampling, extraction and determination for the migration of certain elements including antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium from toy materials and from parts of toys. The standard does not apply to packaging materials unless they are intended to be kept, for example boxes and containers, or unless they form part of the toy or have intended play value.

The newly published standard contains several major changes when compared to the previous version. The key changes include:

• Two detailed dewaxing methods using either soxhlet extractor or solvent extractor have been introduced to replace the original method.
• Definitions of paper and paperboard have been separated. Materials formed by irregular cellulose fibers having a mass per unit area under 400 g/m2 are defined as paper (laminated paper is not treated as paper). Materials like card or cardboard having a mass per unit area over 400 g/m2 is defined as paperboard.

The migration value requirements are provided in Table 1.

Table 1: Maximum acceptable element migration from toy materials

All eight substances are proposed because of their potentially serious and often irreversible effects on human health and the environment. The names of the substances, the reasons for their proposal as SVHC and their potential uses are provided in the below table:

POPs Recast Regulation (consolidated version to September 2020) is an EU restriction on persistent organic pollutants in products, in which Annex I contains a list of substances that are prohibited in manufacturing, placing on the market and use, whether on their own, in mixtures or in articles.

PCP and its salts and esters were listed in Annex I without an Unintentional Trace Contaminant (UTC) limit when the POP Recast Regulation was published in 2019. The European Commission, however, has determined the presence of PCP and its salt and esters as impurities in some articles such as imported textiles and recovered wood chips to produce wood panels since the publication. The new limit is therefore set to allow the continuation of recycling of wood chips and to facilitate enforcement for PCP and its salts and esters. The updated requirement is summarized in Table 1.

Table 1 Requirement of PCP and its salts and esters in Regulation (EU) 2021/277

The decree mentioned:

1. Face masks are mandatory in any public area.
2. At point of sale, compliant masks must be separated from non-compliant masks and distributors must inform when masks comply or not with sanitary authorities' recommendations.
3. The face masks must comply with requirements listed and belong to one of the below categories:
• Surgical mask complying to EN 14683 + AC: 2019 (or equivalent).
• Imported masks with surgical shape, excluding textile fabric masks, which perform at least equal to masks mentioned at the 4th bullet point.
• FFP2 or FFP3 mask complying to EN 149 + A1: 2009 (or equivalent) without expiratory valve.
• Mask for Non-Sanitary Use (UNS) complying with:
1. Particle filtration efficiency > 90% (3 microns);
2. Breathability allowing wearing the mask for 4 hours;
3. Air permeability > 96L/m²/s (differential pressure 100Pa);
4. Good fit of the mask on the face, no sagittal seam;
5. If reusable, the performance levels mentioned should be maintained after at least five washes.

Above requirements must be checked by an approved 3rd party lab and according to conditions mentioned in government decision. It is important to note that reusable textile masks can still be used if they comply with this updated requirement.

French decree n° 2021-76:
https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000043070201

Approved 3rd party lab:
https://www.entreprises.gouv.fr/fr/covid-19/entreprises-comment-faire-tester-masques

As confirmed in a note by the European Commission and Member States on June 23, 2020, the use of bamboo in combination with polymers, such as melamine (so called ”bamboo-melamine”) for the manufacture of plastic food contact materials is not authorized under article 5 of Regulation (EU) No 10/2011.

Controls done by EU Member States have shown that a wide range of non-compliant “bamboo-melamine” composite food contact materials are currently on the EU market. In addition, migration of melamine and formaldehyde have been found on many occasions to be considerably above the limit laid down in Regulation (EU) No 10/2011 leading to the recall of these products from the market.

On February 15, 2021, Belgium, the Netherlands and Luxembourg (Benelux countries) published a joint letter on the use of bamboo or other unauthorized additives in plastic food contact materials placed in the EU market. According to the joint letter, business operators will have to withdraw “bamboo-melamine” materials and articles from the EU market immediately. Importers wishing to bring “bamboo-melamine” products to the EU market will have to submit an authorization dossier according to Regulation (EC) No 1935/2004.

In addition to the joint letter, there were several notifications in the Rapid Alert System for Food and Feed portal (RASFF) on border rejections from Spain and Austria as the notified products are “bamboo-melamine” products.

The scope of application of this standard is consumer products, including product components, parts, accessories, packaging, and instructions for use. It is not applicable to products under special government supervision such as food, medicine, cosmetics, tobacco, special equipment, airplanes, ships, and military products.

This new standard was created based on the European Union (EU) "REACH Regulation ((EC) No 1907/2006)". Limit requirements in this standard are taken from "EN71-9 General Requirements for Organic Compounds in Toys", "EN71-12: 2013 Toy Safety-Part 12 N-nitrosamines and N-nitroso compounds" and the "Ecological textile standard Oeko-tex100-2017" and other foreign standards restriction (limit) requirements. Restricted substances include heavy metals, alkanes, halogenated alkanes and alkenes, benzenes, polycyclic aromatic hydrocarbons, phenols, aldehydes, ethers, alcohols, esters and salts, amines, dyes, and other unclassified chemicals in consumer products; 117 categories included.

The creation of this standard allows for quality and safety supervision of consumer products, provides consistent safety technical requirements for the design and manufacture of products, and provides a technical frame of reference for various institutions.

GB/T 4146.1 lists out names of the various chemical fibers based on the main polymers for industrial production, textile and other uses, and gives their main characteristics.
The new version includes many updates to the old version, with the key technical differences as follows:

1. Added terms and definitions of “man-made fiber/ chemical fiber”. Man-made fiber/ chemical fiber: Fibers which are made by man, except natural fibers.
2. Added generic name, symbol, main characteristic, and chemical formula to 12 kinds of chemical fibers, including:
   Modacrylic, chitosan, melamine, protein, trivinyl, polybenzimidazol, elastomultiester, polyamidoester, silicon carbide, polyhydroxy, polycarbamide and polyarylate.
3. Polyvinyl alcohol fibers are divided into acetal and non-acetal types; specified vinylon is short for polyvinyl alcohol fiber.
4. Added the name of bicomponent composite fiber, such as:
   Polyester/polyester bicomponent
   Polyethylene/polypropylene bicomponent
   Polypropylene/polyamide bicomponent
   Polyester/polyamide bicomponent
   Polyethylene/polyester bicomponent
5. Added four informative annexes, including:
• Annex A: Suggested rules for establishing generic names
• Annex B: Composite fiber
• Annex C: Modified fiber
• Annex F: Requirements for generic names in related region and state

The Toys and Children’s Products Safety Ordinance stipulates that a person must not manufacture, import, or supply a toy or a Schedule 2 product unless it complies with all the applicable requirements contained in any one of the safety standards respectively specified in Schedules 1 and 2 to the Ordinance. The standards specified are international standards or standards adopted by major economies.

Proposed updates to Standards Specified for Toys and Schedule 2 Products:

For a complete list click here