ECHA Consults on Amendment of RAECH Annex XIV for Four Phthalates

On December 12, 2018, ECHA issued a notice to conduct public consultation on the amendment of annex XIV of REACH Regulation to the list of four phthalates authorized for their endocrine disrupting properties. The deadline for comments is 12 March 2019.

The information of the four phthalates is as follows:

These four phthalates have previously been identified as substances of very high concern (SVHCs) due to their reprotoxic and endocrine disrupting properties.

This amendment will mean that some uses which until now have been exempted may require authorization, such as:

1. Uses of the four phthalates in mixtures in concentrations equal or above 0.1 % w/w (so far the concentration limit has been 0.3 % w/w);

2. Some uses of DEHP (e.g. in food contact materials or medical devices) that will no longer fall under the ‘generic exemptions from the authorization requirement’ due to the endocrine disrupting effects on the environment of DEHP.

Two Substances Added to the List of Prop 65

On November 23, 2018, the Office of Environmental Health Hazard Assessment (OEHHA) is adding gentian violet and N-nitrosohexamethyleneimine to the list of Prop 65. At a public meeting on November 1, 2018, the Carcinogen Identification Committee (CIC) in its official capacity as the “state’s qualified experts” (SQE)[2] determined that gentian violet and N-nitrosohexamethyleneimine were clearly shown by scientifically valid testing.

The information of two substances is as follows:

* Listing mechanism:  SQE – “State’s Qualified Expert” mechanism (Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25305(a)(1)).

Gentian violet is often used in the ink, toner and textile dyeing. It also can be used medically as disinfectant, preservative, cosmetics hair dye.

The California law requires manufacturers and retailers to warn workers and consumers exposed to chemicals on the list.

EU Council Backs Lower POPs Limit on DecaBDE Flame Retardants

On November 28, 2018, the European Council has approved the recast of the Regulation on Persistent Organic Pollutants (POPs), which was adopted by the European Parliament earlier this month. The Council has also endorsed a 500 ppm limit for the cumulative sum of polybrominated diphenyl ethers (PBDEs) and a 10,000 ppm limit for short-chain chlorinated paraffins (SCCPs) in products.

The 500 ppm limit for PBDEs is lower than in the original proposal (1000 ppm) but higher than the 50 ppm value campaigned for by several non-governmental organizations (NGOs). The NGO European Environmental Bureau (EEB) commented that this value “is an improvement” compared to the initial proposal, but still “not sufficient to protect people’s health and the environment.”

The 10,000 ppm limit set for SCCPs is much higher than the 100 ppm limit proposed by the NGOs. Karolina Brabcova, consumer campaigns coordinator at the NGO Arnika, called it “outrageously high.” She informed that “campaign efforts on this issue will continue with some member states keen to revisit the values.”

EU Identified 3-Benzylidene Camphor as SVHC Substance

On December 18, 2018, the Official Journal of European released the directive (EU) 2018/2013, identified 1,7,7-trimethyl-3-(phenylmethylene) bicycle [2.2.1] heptan-2-one (3-benzylidene camphor) as a substance of very high concern according to Article 57(f) of REACH Regulation. 3-benzylidene camphor has endocrine interference properties and may cause serious impact on the environment. It will be added to the candidate list of SVHC later.

The information of 3-benzylidene camphor is as follows:

Manufacturers and exporters have to notify ECHA under the following circumstances since the substance is added to SVHC candidate list:

1. The product containing SVHC materials, whose content exceeds 0.1%;

2. In later 6 months, the product containing more than 0.1% the concentration of a single SVHC in the article and the annual export volume is more than 1 ton, shall notify the ECHA.

CPSC Implements Interim Policy for Mattress Pads

On November 1, 2018, the USA Consumer Product Safety Commission (CPSC) implemented an Interim Enforcement Policy allowing reduced testing for mattress pads which are subject to 16 CFR 1632 – Standard for the Flammability of Mattresses and Mattress Pads due to a shortage of standard reference material (SRM) cigarettes.

The CPSC has recently learned that the inventory of SRM 1196 cigarettes, which is specified by the Standard as the ignition source for flammability testing of mattresses and mattress pads, is critically low, and the National Institute of Standards and Technology (NIST) does not have a source to produce new SRM 1196 cigarettes and is looking for a new producer.

As a result of the shortage of SRM cigarettes, the new interim enforcement policy for mattress pads will allow mattress pad manufacturers o reduce testing from six mattress pad surfaces to two mattress pad surfaces for each new prototype that is tested to the Standard. A prototype will be accepted if the char lengths of the 18 individual cigarettes are not more than 2 inches in any direction from the nearest point of the cigarette on two mattress pad surfaces. The mattress pads must be tested to the bare surface unopened packages of SRM cigarettes for each series of tests. Relaxing this requirement will allow partial packs of SRM cigarettes to be used when conducting the tests.

The new interim enforcement policy for mattress pads became effective on November 1, 2018, and will remain effective until further notice.

US Revises ASTM F2413-18 for Performance Requirements of Protective Footwear

ASTM F2413 covers the minimum requirements for the performance of footwear to provide protection against a variety of workplace hazards that can potentially result in injury. In the 2018 version, test report and Certification of Conformance (COC) are required to be issued by a third-party laboratory for the safety hazard(s) applicable to the footwear or/and puncture resistant devices.

Protective footwear requirements are referenced in the Occupational Safety and Health Administration’s (OSHA’s) Code of Federal Regulations (CFR) Title 29. General Personal Protective Equipment (PPE) requirements are given in section 1910.132 and Foot Protection requirements in section 1910.136. 29 CFR 1910.136(a) states each affected employee must wear protective footwear when working in areas where there is a danger of foot injuries due to falling or rolling objects or objects piercing the sole or from an electrical hazard. The requirements are referenced in ASTM F2412 Standard Test Methods for Foot Protection and F2413 Standard Specification for Performance Requirements for Protective (Safety) Toe Cap Footwear.

ASTM F2413-18 covers the minimum requirements for the design, performance, testing and classification of protective footwear. Footwear certified as meeting ASTM F2413-18 must first meet the requirements of Section 5.1 Impact Resistant Footwear (I) and Section 5.2 Compression Resistant Footwear (C). Then the requirements of additional sections such as Metatarsal protection (Mt), Conductive protection (Cd), Electric hazard protection (EH), Static dissipative protection (SD) and Puncture resistance (PR) can be met.

All footwear manufactured to the ASTM specification must be marked with the compliance to the specific portion of the standard. One shoe of each pair must be clearly and legibly marked (stitched in, stamped on, pressure sensitive label, etc.) on the inside or outside surface of the tongue, gusset, shaft or quarter lining. The marking must be enclosed in a rectangular border and a four-line format is suggested.

  • Line 1 – identifies compliance with ASTM F2413 standard
  • Line 2 – identifies gender of user (M / F) and the classification for impact resistance (I), compression resistance (C) and metatarsal resistance (Mt) provided
  • Line 3 & 4 – identifies the other specific types of hazards the footwear protects referenced in the standard 

In the 2018 version, protective footwear must comply with the ASTM standard with test report and Certification of Conformance (COC) issued by an independent third-party laboratory. The test report shall reference ASTM Test Methods F2412 and ASTM Specification F2413 including the following information:

  • name of the third-party laboratory, contact information and authorization signature(s)
  • full description of the sample footwear and/or puncture resistant devices tested
  • any manufacturer’s reference (product category, style, model, SKU etc.), size and gender
  • performance requirements and safety hazard(s)
  • results, test conditions and if any modification of the test methods 

A Certification of Conformance (COC) shall be issued by a third-party laboratory for the safety hazard(s) applicable to the tested footwear and/or puncture resistant devices, including the following information:

  • name of the third-party laboratory, contact information and authorization signature(s)
  • name of the company issued the Certificate of Compliance (COC)
  • all manufacturer’s references (product category, style, model, SKU, etc)
  • certification issue date
  • report number and issue date associated with the Certificate of Compliance (COC)
  • statement that the manufacturer’s reference meets the performance requirements of ASTM Specification F2413-18 as tested in accordance with ASTM Test Methods F2412-18 and list the safety hazard(s) tested.

New Amendment to Toy Standard ISO 8124-3 Published

Recently, the International Organization for Standardization (ISO) published amendment 2 (Amd 2) to toy standard “ISO 8124-3:2010 Migration of Certain Elements” to revise the limits for finger paint. In this amendment, ISO lowers migration limits of antimony (Sb), arsenic (As), cadmium (Cd), lead (Pb), mercury (Hg) and selenium (Se) for finger paint, while higher the limit of barium (Ba). There is also an exception for element chromium (Cr) which remains unchanged. The comparison of new and old limits for finger paint is showed in Table 1.

There are two sets of migration limits in the previous version of the standard. One is for modeling clay and finger paint, and another one is for other materials for toys. Considering the specific exposure conditions for finger paint compared with other toy materials, ISO standard committee reduced the limits of certain elements for finger paint to further protect children’s health. That makes the standard now has three different sets of migration limits for modeling clay, finger paint and other toy materials respectively.

Table 1

Denmark Identified Nine New Endocrine Disrupting Chemicals

On October 31, 2018, The Danish environment ministry published a major study that identified nine new substances as endocrine disrupting chemicals (EDCs) based on “solid scientific evidence”.

The nine chemicals identified as EDCs are:

  1.  Prochloraz (CAS 67747-09-5)
  2. triclocarban (CAS 101-20-2)
  3.  octamethylcyclotetrasiloxane (D4, CAS 556-67-2)
  4.  tris(methylphenyl) phosphate (CAS 1330-78-5)
  5.  salicylic acid (CAS 69-72-7)
  6.  fenitrothion (CAS 122-14-5)
  7.  di-n-pentylphthalate (CAS 131-18-0)
  8.  bisphenol AF (BPAF, CAS 1478-61-1)
  9.  isobutyl paraben (CAS 4247-02-3)

Salicylic acid is included in the Union List of substances authorized for use in plastic food contact materials (FCMs) (Annex I of Regulation (EU) No 10/2011), and D4 is also added to the REACH Candidate List of substances of very high concern (SVHCs) due to its very persistent and very bioaccumulative (vPvB) as well as persistent, bioaccumulative and toxic (PBT) properties. BPAF may currently be used as a replacement chemical for bisphenol A.

California Adds Soluble Nickel Compounds to Prop 65

On October 26, 2018, the Office of Environmental Health Hazard Assessment (OEHHA) released a notice to add Nickel (soluble compounds) to the list of Prop 65, with immediate effect. On October 11, 2018, the Developmental and Reproductive Toxicant Identification Committee (DARTIC) determined that soluble nickel compounds can cause reproductive toxicity based on the developmental and male reproductive endpoints.

Soluble nickel compounds are listed in Prop 65 as follows:

* Listing mechanism:  SQE – “State’s Qualified Expert” mechanism (Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25305(b)(1)).

US Proposes to Amend Consumer Registration of Durable Infant or Toddler Products

On October 9 2018, the U.S. Consumer Product Safety Commission (CPSC) published a proposed rule to amend the consumer registration requirements of durable infant or toddler products under the Consumer Product Safety Improvement Act (CPSIA). The revised rule would have 12 months to become effective after its publication on the Federal Register once adopted.

The Commission advances to update the definition of product, clarify the scope of listed product categories, and add six additional product categories that fell within the scope.

In the proposed rule, the Commission would like to

State the full statutory definition of “durable infant or toddler products”;
Specify the scope of listed product categories that are defined in the applicable mandatory standards;
Align the listed product category with the name used in the voluntary or mandatory standard;
List four types of infant carriers that are also subject to the consumer registration requirement;
Remove the “infant slings” as a separate product category and change the name to “sling carriers”:
Clarify the “bedside sleepers” that are considered as a subset of bassinets and cradles; and
Revise “changing tables” to “baby changing products”.

Though many bedside sleepers on the market are for use with play yards or standalone bassinets, the Commission reminded that such multiuse products are also required to provide a consumer registration under the Act. Similarly, contoured changing pads and add-on changing units are subject to the registration requirement under baby changing products despite they are sold independently.

The Act defines durable products that are intended for use or expected to be used by children under 5 years old. Section 104 of the CPSIA, also called Danny Keysar Child Product Safety Notification Act, requires the Commission to issue a mandatory rule for each durable infant or toddler product, and establish a rule requiring consumer registration for each product. The implementation regulation was published in 2009 and codified at 16 CFR 1130. Currently, the rule includes twelve product categories that fell within the scope of durable infant or toddler products.