März 2021

ASTM International published ASTM F3502-21 in February 2021 which provides specifications for both single and reusable non-medical barrier face coverings; the standard was developed by subcommittee F23.65 for respiratory protection.

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

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.

On February 16, 2021, TPCH announced the organization’s update to its ‘Model Legislation’. In addition to maintaining the regulated four heavy metals, the legislation has been expanded to restrict the class of perfluoroalkyl and polyfluoroalkyl substances (PFAS) and ortho-phthalates in packaging and packaging materials.

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 February 2021, Washington State has announced that PFAS in four types of food packaging will be banned as of February 2023.

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 International published a new safety standard for child safety locks and latches - ASTM F3492-21 on February 2021. This standard applies to child safety locks and latches for use with cabinet doors and drawers to restrict access to household cabinets by children under the age of 48 months.

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

On March 8, 2021, the U.S. EPA asked for additional public input to re-examine on five final rules for persistent, bioaccumulative and toxic (PBT) chemicals issued on January 6, 2021 under the TSCA. This included an additional 60-day comment period for the five PBT chemicals and a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the rule for Phenol, isopropylated phosphate (3:1) [PIP (3:1)].

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:

On March 9, 2021, the European Chemicals Agency (ECHA) published proposals to identify eight chemicals as Substances of Very High Concern (SVHC) and possible candidates for authorization. Interested parties are invited to comment on the eight proposals by April 23, 2021. If the eight proposals are accepted, the Candidate List of SVHC will expand to 219.

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:

The European Commission has approved Commission Delegated Regulation (EU) 2021/277 to amend Annex I to POP Regulation (EU) 2019/1021 regarding the entry of Pentachlorophenol (PCP) and its salts and esters with setting its Unintentional Trace Contaminant (UTC) limit at 5 ppm by weight. The update shall enter into force on March 15, 2021.

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

To avoid the spread of mutated Covid-19, the French government published a new decree, n° 2021-76, on January 27, 2021 and updated the Cross Ministries Note on January 28, 2021, recommending using masks with a higher filtration efficiency; face masks with a filtration efficiency lower than 90% are not recommended.

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:

     • Particle filtration efficiency > 90% (3 microns);

     • Breathability allowing wearing the mask for 4 hours;

     • Air permeability > 96L/m²/s (differential pressure 100Pa);

     • Good fit of the mask on the face, no sagittal seam;

     • 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

Am 15. Februar 2021 veröffentlichten die Benelux-Länder ein gemeinsames Schreiben, um die Verwendung von Bambus oder anderen nicht zugelassenen Zusatzstoffen in Kunststoffmaterialien mit Lebensmittelkontakt auf dem EU-Markt zu verbieten. Die Benelux-Behörden werden ab dem zweiten Quartal 2021 mit verstärkten Marktkontrollen beginnen. Im Falle der Nichteinhaltung werden die Benelux-Behörden Vertragsverletzungsverfahren einleiten.

Wie in einem Vermerk der Europäischen Kommission und der Mitgliedstaaten vom 23. Juni 2020 bestätigt, ist die Verwendung von Bambus in Kombination mit Polymeren wie Melamin (sogenanntes "Bambus-Melamin") für die Herstellung von Kunststoffmaterialien mit Lebensmittelkontakt gemäß Artikel 5 der Verordnung (EU) Nr. 10/2011 nicht zulässig.

Die von den EU-Mitgliedstaaten durchgeführten Kontrollen haben gezeigt, dass sich derzeit eine breite Palette von nicht konformen "Bambus-Melamin-Verbundwerkstoffen" mit Lebensmittelkontakt auf dem EU-Markt befindet. Darüber hinaus wurde in vielen Fällen festgestellt, dass die Migration von Melamin und Formaldehyd deutlich über dem in der Verordnung (EU) Nr. 10/2011 festgelegten Grenzwert liegt, was zum Rückruf dieser Produkte vom Markt führte.

Am 15. Februar 2021 veröffentlichten Belgien, die Niederlande und Luxemburg (Benelux-Länder) ein gemeinsames Schreiben über die Verwendung von Bambus oder anderen nicht zugelassenen Zusatzstoffen in Kunststoffmaterialien mit Lebensmittelkontakt, die in der EU in Verkehr gebracht werden. Dem gemeinsamen Schreiben zufolge müssen die Unternehmen Materialien und Gegenstände aus Bambus-Melamin" unverzüglich vom EU-Markt nehmen. Importeure, die "Bambus-Melamin"-Produkte auf den EU-Markt bringen wollen, müssen ein Zulassungsdossier gemäß der Verordnung (EG) Nr. 1935/2004 einreichen.

Zusätzlich zu dem gemeinsamen Schreiben gab es mehrere Meldungen im Schnellwarnsystem für Lebens- und Futtermittel(RASFF) über Zurückweisungen an der Grenze aus Spanien und Österreich, da es sich bei den gemeldeten Produkten um "Bambus-Melamin"-Produkte handelt.

On November 19, 2020, the Standardization Administration of China published a voluntary standard GB/T 39498-2020 "Guidelines for the Control of the Use of Key Chemical Substances in Consumer Products" on restriction of hazardous substances in consumer products, which will come into effect on June 1, 2021.

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.

The Standardization Administration of the People’s Republic of China recently released announcement No.22 of 2020, which included the update that GB/T 4146-2020 “Textiles—Man-made fibers—Part 1: Generic names” has replaced the 2009 version. It will be effective on May 1, 2021.

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

On February 19, 2021, the Hong Kong government has published in the Gazette the Toys and Children’s Products Safety Ordinance (amendment of Schedules 1 and 2) Notice 2021. The Notice seeks to update the safety standards for toys and three classes of children’s products listed in Schedule 2 (Schedule 2 products) under the Toys and Children’s Products Safety Ordinance (Cap. 424). The Notice will take effect on October 1, 2021.

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:

In China, when hazards are identified in consumer products, they will be recalled and published and this information is updated daily. The China recalls from October 1, 2020 to March 15, 2021 are summarized below:

For a complete list click here

Standards Australia und Standards New Zealand haben im Februar 2021 eine neue Version von Safety of Toys AS/NZS 8124-3 Migration of Certain Elements veröffentlicht. Die Version 2021 ersetzt die AS/NZS ISO 8124.3:2012 und deren Änderung 1:2016.

Die Sicherheitsnorm für Spielzeug wurde ursprünglich in Australien als Teil von AS 1647-1974 erstellt und später gemeinsam überarbeitet und als AS/NZS ISO 8124.3 neu benannt. Die neue Version AS/NZS ISO 8124.3:2021 übernimmt identisch die im März 2020 veröffentlichte ISO 8124-3:2020, die zulässige Höchstwerte und Methoden zur Probenahme, Extraktion und Bestimmung der Migration bestimmter Elemente einschließlich Antimon, Arsen, Barium, Kadmium, Chrom, Blei, Quecksilber und Selen aus Spielzeugmaterialien und Teilen von Spielzeug festlegt. Die Norm gilt nicht für Verpackungsmaterialien, es sei denn, sie sind zur Aufbewahrung bestimmt, z. B. Schachteln und Behälter, oder sie sind Teil des Spielzeugs oder haben einen bestimmten Spielwert.

Die neu veröffentlichte Norm enthält mehrere wichtige Änderungen im Vergleich zur vorherigen Version. Zu den wichtigsten Änderungen gehören:

• Als Ersatz für die ursprüngliche Methode wurden zwei detaillierte Entparaffinierungsmethoden eingeführt, bei denen entweder ein Soxhlet-Extraktor oder ein Lösungsmittelextraktor verwendet wird.

• Die Definitionen von Papier und Pappe wurden getrennt. Materialien, die aus unregelmäßigen Zellulosefasern bestehen und eine Flächenmasse von weniger als 400 g/m2 haben, werden als Papier definiert (laminiertes Papier wird nicht als Papier behandelt). Materialien wie Pappe oder Karton mit einem Flächengewicht über 400 g/m2 werden als Pappe definiert.

Die Anforderungen an den Migrationswert sind in Tabelle 1 aufgeführt.

Tabelle 1: Maximal zulässige Elementmigration aus Spielzeugmaterialien