EU Issues Guidance for Soft-Filled Toys with Sequins

On February 19, 2019, the Administrative Cooperation (ADCO) group of the Expert Group on Toy Safety, which is a group of market surveillance authorities supported by the European Commission, issued a note regarding the age grading of sequin-covered soft-filled toys. The decision given in the document represents the view of the majority of market surveillance authorities.

The increasing popularity of these toys and the potential for safety issues has raised regulatory concern. Unlike plush toys covered with soft textiles, the surfaces of the sequin toys are comparatively hard and rough. Some manufacturers market them as toys for children above 3 years old.

The ADCO concluded that the sequin-covered toy has a similar design to soft-filled toys with coverings from which pieces can be bitten or torn off. Such toys should, therefore, meet the requirements in clause 8.3 (torque test) and 8.4 (tension test) as required in 5.1 (toys intended for children under 36 months, general requirements) under EN 71-1.

Sequin-covered soft-filled toys must be safe for children of all ages. Manufacturers are not allowed to add the age warning, “Not suitable for children under 3 years old”, nor the age warning symbol on the toys to circumvent the small part requirements.

ECHA to Evaluate 31 Substances in 2019

On March 19, 2019, 19 ECHA Member States planned to evaluate 100 substances over the next three years. For the 31 substances specified for 2019, the evaluating authorities have 12 months from today to carry out their evaluations.

The primary purpose of the evaluation is to clarify whether further information is needed to conclude whether a substance poses a risk to humans or the environment. If necessary, the registrant is required to provide this information. Authorities assess suspicious issues and initiate regulatory risk management actions where relevant.

ECHA encourages registrants of listed substances to coordinate their actions and liaise with evaluating member states. Registrants are also urged to update their profiles, especially for purposes and risks and make comments before any decision to request further information. Member states and the ECHA will review the evaluating authorities draft decision before making a final decision.

These substances are assessed based on problems associated with their severe hazard characteristics. The substances may be suspected sensitizers, persistent, bioaccumulative and toxic (PBT) substances, carcinogenic, mutagenic and reprotoxic (CMR) substances or endocrine disruptors. The selection also considers wide dispersive worker or consumer use. The evaluation may also result in the identification of other concerns on the substances.

California Established Prop 65 Safe Harbor Level for N-Hexane

On March 21, 2019, California’s Office of Environmental Health Hazard Assessment (OEHHA) has established Proposition 65 maximum allowable dose levels (MADLs) for oral and inhalation exposures to n-hexane. The regulation begins on July 1, 2019.

The MADLs for n-hexane are set at:

  • 28000 micrograms per day for oral exposure
  • 20000 micrograms per day for inhalation exposure

An MADL represents a safe harbor exposure limit below which a company is not required to provide a Prop 65 warning.

N-hexane is a degreaser, solvent component, and low-temperature thermometer filling. It was listed as a reproductive toxicant under Prop 65 in December 2017.

U.S. FTC Seeks Public Comment on Leather Guidelines

The United States Federal Trade Commission (FTC) has opened a public consultation on the future of the Leather Guides. Issued on February 6, 2019, the FTC will accept comments for sixty days on whether there is a continued need for the guides covering Select Leather and Imitation Leather Products (Leather Guides).

As part of this process, the Commission is also asking stakeholders:

  • If deceptive or unfair advertising and marketing practices are being used to sell leather and imitation leather products
  • Whether the Leather Guides should be expanded to cover products not currently included – e.g., automotive and furniture upholstery products

The Leather Guides were published in 1996 to guide the rules governing labeling for leather and imitation leather products. They address misrepresentations about the composition and characteristics of specific leather and imitation leather products and require all non-leather content that appears to be leather to be so identified.

The guidelines apply to the manufacture, promotion, and distribution of leather and imitation leather purses, luggage, wallets, footwear, and similar products, with the intention that false information or deceptive practices are not being used to sell products, and to promote truthful, non-misleading advertising to consumers.

EU Makes 16 Updates to RoHS Exemption List

On Mar. 13, 2019, the European Commission issued updates to the European Union (EU) Restriction of Hazardous Substances (RoHS) Directive exemption list. It extended nine expired exemptions and added seven new exemptions.

Six of the seven new exemptions put additional restrictions on specific categories. Meanwhile, the organization incorporated one brand new exemption (Exemption 42) that applies only to Category 11 (all other electrical and electronic equipment (EEE)).

All except is set to begin on March 1, 2020. Exemption 42 takes effect when Category 11 begins on July 22, 2019. The new category applies to “lead” in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment (with engine total displacement thresholds).

All other exemptions listed in its report are unchanged until March 1, 2020.

The expiring exemptions listed in the table are only active for one more year. So, time is running out to implement corrective measures to keep your product on the market. If your products fall under the RoHS Directive, we recommend you review the exemptions to determine any impact. If exemptions apply, you must request updated declarations from suppliers that rely on these exemptions or determine whether a new exemption applies. By doing so, you can ensure your products comply when shipped into the EU.

ECHA Seeks for Public Consultation on 3 Potential Substances of Very High Concern

On March 13, 2019, the European Chemical Agency (ECHA) launched its public consultation of on six potential Substances of Very High Concern (SVHC). The 3 proposed substances in the consultation are listed as below. The deadline for commenting is April 29, 2019.

Name EC Number CAS Number Proposing authority Reason for proposing
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) Netherlands Equivalent level of concern having probable serious effects on the environment (Article 57f)

Equivalent level of concern having probable serious effects on human health (Article 57f)

2-methoxyethyl acetate 203-772-9 110-49-6 Sweden Toxic for reproduction (Article 57c)
Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) France Endocrine disrupting properties (Article 57(f) – environment)


AAFA Releases 20th Edition of Restricted Substance List

The American Apparel & Footwear Association (AAFA) publishes the 20th edition of the Restricted Substance List (RSL). The list covers substances and chemicals related to finished apparel, footwear, and home textile products.

The 20th edition of the RSL covers 12 categories with more than 250 chemicals and is updated to reflect additions or changes to regulations and laws that restrict or ban certain chemicals in finished apparel, footwear, and home textile products. The RSL is produced by AAFA’s RSL Task Force, which reviews and updates the list regularly to reflect the latest global regulatory changes.

Compared with the previous edition, the 20th edition mainly updates the requirements of 9 kinds of substance, including:

  1. Quinoline;
  2. Basic Violet 3;
  3. 2,4-diaminoanisole sulphate;
  4. 4-chloro-o-toluidinium chloride;
  5. Decabromodiphenyl ether (decaBDE);
  6. Benzene;
  7. Benzotrichloride;
  8. p-Chlorobenzotrichloride;
  9. Benzyl chloride

EU to Add 12 Substances to REACH Authorization List

On February 15, 2019, the European Commission’s (EC) notified the WTO of a draft regulation to add additional 12 substances of very high concern (SVHCs) to the REACH Authorization List (Annex XIV). The substances are proposed to be added in October 2019.

Six of the substances (or substance groups) are included based on their toxicity for reproduction category 1B and include:

  1. 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (CAS 68515-50-4, );
  2. 2)dihexyl phthalate (CAS 84-75-3);
  3. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters (CAS 68515-51-5); 1,2-benzenedicarboxylic acid, mixed decyl, hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (CAS 68648-93-1);
  4. trixylyl phosphate (CAS 25155-23-1);
  5. sodium perborate, perboric acid, sodium salt;
  6. sodium peroxometaborate

Four of the substances are persistent, bioaccumative and toxic (PBT), and/or very persistent and very bioaccumulative (vPvB), and one is included as just vPVB. These include:

  1. 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] (covering any of the individual stereoisomers of [1] and [2] or any combination thereof) (‘karanal group’);
  2. 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328, CAS 25973-55-1);
  3. 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327, CAS 3864-99-1);
  4. 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350, CAS 36437-37-3);
  5. 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320, CAS 3846-71-7).

One other substance is included as a respiratory sensitizer category 1: 12) diazene-1,2-dicarboxamide (C,C’-azodi (formamide)) (ADCA, CAS 123-77-3). Substances 3) and 9) to 12) are included in the FACET inventory of food contact materials (FCMs).

The EC has proposed to adopt the draft regulation in October 2019 based on a World Trade Organization (WTO) notification.

Mercosur Amends Labeling Requirements for Textiles and Apparel

The Mercosur Common Market Group recently issued a regulation modifying the current regional labeling requirements for textiles and apparel. Mercosur member nations have until June 15, 2019, to incorporate these new requirements into their respective national legislation.

MERCOSUR is a South American economic and political entity designed to facilitate free trade among its members. Current full members include Argentina, Brazil, Paraguay, and Uruguay.

The new regulation does not appear to include any significant changes to the requirements of GMC Resolution 33/07. Some of the more notable modifications are summarized below.

  • One fiber representing less than five percent by weight or two or more fibers representing less than 15 percent by weight of the fiber content of a product may be disclosed as “other fiber” or “other fibers”, as applicable (this threshold is currently 10 percent).
  • A new provision clarifies that when the textile yarn is intrinsically added to a fabric made from a different yarn, thereby becoming an integral part of that fabric, the fiber content of such fabric must reflect the incorporation of such yarn.
  • Care labeling is required to be carried out per ISO 3758:2013, compared to ISO 3758:2005 currently.
  • New language explicitly requires the ISO 3758:2013 care symbols to be used in the correct order and comply with certain other conditions.
  • Elastomultiester and melamine are added as generic fibers.
  • Lined buckles are now on the list of exclusions from the labeling requirements, Christmas and similar decorations and stuffed door seals and removing textile products for rent.

EU Amends Directive 2011/65/EU on New Exemptions for Cadmium and Lead

On February 5, 2019, ten new directives were published in the EU Official Journal amending Annex III to Directive 2011/65/EU (RoHS) regarding the renewal of nine existing exemptions and the addition of one exemption for lead in new uses. The new provisions take effect on 25 February 2019.

Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (ROHS 2)restricts the use of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) in electrical and electronic equipment. However, the applications listed in Annexes III and IV of RoHS 2 are exempted from these restrictions. Under Article 5 of RoHS 2, the European Commission must ensure that the exemptions contained in the annexes are adapted to scientific and technical progress.

On November 16, 2018, all ten Commission Delegated Directives were adopted by the EU Commission.

Nine of them extend existing exemptions listed in Annex III of RoHS 2 for the use of lead, lead oxide, or cadmium in the specified applications:

  • Lead in dielectric ceramic in specific capacitors
  • Lead in PZT based dielectric ceramic materials for specific capacitors
  • Cadmium and its compounds in electrical contacts
  • Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages
  • Lead and cadmium in printing inks for the application of enamels on glasses
  • Lead bound in crystal glass
  • Lead oxide in seal frit used for making window assemblies for certain laser tubes
  • Lead in the plating layer of certain diodes
  • Lead as activator in the fluorescent powder of discharge lamps containing phosphors

The final directive adds an exemption for lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment.

For all directives, EU member states must adopt a national act transposing them no later than 21 July 2019. They must be applied to start 22 July 2019.

Manufacturers and distributors of electrical and electronic equipment and their supply chains should note one exception for lead, as well as nine exemptions,  renewed to the RoHS restrictions concerning lead and cadmium. Potentially affected companies should review the exemptions contained in these new directives to establish whether the changes impact their operations.