US Publishes High Chair Standard ASTM F404-18A

On January 15, 2019, the standard ASTM F404-18a on safety specification for high chair was published. In this revision, certain high chairs and high chair accessories are temporarily excluded from the stability requirements under section 6.5. However, this measure will be reevaluated once the test methods are developed.

The exemption includes high chairs and high chair accessories that are used only by children who are unable to sit upright unassisted and weigh 20 lb (9.1 kg) or less. However, a specific warning is required to alert consumers using these types of high chairs for child who is able to sit upright unassisted or weighs more than 20 lb (9.1 kg).

ASTM F404 defines a high chair as “a free standing chair for a child up to 3 years of age which has a seating surface more than 15 in. above the floor and elevates the child normally for the purposes of feeding or eating.” It further specifies that a high chair may be sold with or without a tray, have adjustable heights, or recline for infants.

The Consumer Product Safety Improvement Act of 2008 (CPSIA) section 104 requires the Consumer Product Safety Commission (CPSC) to issue standard for durable infant or toddler products including high chair. The previous standard ASTM F404-18 was published by the Commission as mandatory standard for high chairs under 16 CFR 1231 and becomes effective on June 19 of this year.

EU Adds Substances as Food Contact Materials

On January 11, 2018, the Official Journal of European Union issues the Directive (EU) 2019/37, amending and correcting the Annex I and Annex III of Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Directive may be placed on the market until January 30, 2020 and may remain on the market until exhaustion of stocks. This Regulation shall enter into force from January, 31 2019.

 

Annexes I and III to Regulation (EU) No 10/2011 are amended as follows:

 

(1) In Annex I, Table 1 is amended as follows:

 

(a). The entries concerning FCM substances No. 467, 744, 1066, and 1068 are replaced by the following:

 

Substance No. Ref No. CAS No. Name of Substance Specific Migration Limit Restrictions and Norms 
467 14800 3724-65-0 crotonic acid
45600
744 18888 080181-31-3 3-hydroxy-butanoic acid-3- hydroxy-pentanoic acid, copolymer The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.
1066 23985-75-3 1,2,3,4-tetrahydrona-phthalene-2,6-dicarboxylic acid, dimethyl ester 0.05 Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).
1068 2530-83-8 [3-(2,3-epoxypropoxy)-propyl]-trimethoxy silane Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).

 

(b). The following entries are inserted in numerical order of the FCM substance numbers:

Substance No. CAS No. Name of Substance Restrictions and Norms
1059 147398-31-0 poly((R)-3-hydroxy-butyrate-co-(R)-3-hydroxy-hexanoate) Only to be used alone or blended with other polymers in contact with foods for which food simulant E is assigned in Table 2 of Annex III.
1067 616-38-6 dimethyl carbonate Only to be used:
a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4′-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short–term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or
b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.
1069 75-28-5 isobutane Only to be used as a blowing agent.

 

(2) In Table 2 of Annex I, the following entry is added:

35 467 0.05 expressed as “crotonic acid”
744
1059

 

(3) In Table 3 of Annex I, the following entry is added:

(27) When a final material or article containing this substance and produced under conditions other than those described in point (a) column 10 of Table 1 is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in point (b) column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.

 

(4) In Table 4 of Annex I, the row concerning restriction of the entry concerning substance FCM No 744 is replaced by the following:

Restriction Specific migration limit for crotonic acid is 0.05 mg/kg

 

(5) In table 3 of point 4 of Annex III, the third and fourth rows are replaced by the following:

All aqueous and alcoholic foods and milk products with a pH ≥ 4.5 food simulant D1
All aqueous and alcoholic foods and milk products with a pH < 4.5 food simulant D1 and food simulant B

EU to Revise Formaldehyde and Aluminum Content in Toys

The European Commission has recently notified World Trade Organization (WTO) of the amendments to Toy Safety Directive, and is seeking feedback on specific limit values it is proposing to adopt for formaldehyde and aluminum in toys.

 

Reference Date Title
G/TBT/N/EU/626 10/12/2018 Draft Commission Directive amending, for the purposes of adaptation to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards aluminum.

This Draft lowers the migration limits for aluminum as below:

·         2250 mg/kg in dry, brittle, powder-like or pliable toy material

·         560 mg/kg in liquid or sticky toy material

·         28130 mg/kg in scraped-off toy material

G/TBT/N/EU/635 18/12/2018 Draft Commission Directive amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council for the purpose of adopting specific limit values for chemicals used in certain toys, as regards formaldehyde.

This draft Commission Directive aims to include, in Appendix C to Annex II to Directive 2009/48/EC, limit values for formaldehyde in polymeric toy material, resin-bonded wood toy material, textile toy material, leather toy material, paper toy material and water-based toy material.

Proposed limit values for formaldehyde:

·         1,5 mg/l (migration limit) in polymeric toy material

·         0,1 ml/m3 (emission limit) in resin-bonded wood toy material

·         30 mg/kg (content limit) in textile toy material

·         30 mg/kg (content limit) in leather toy material

·         30 mg/kg (content limit) in paper toy material

·         10 mg/kg (content limit) in water-based toy material

Six New Substances Added to Candidate List of SVHC

Six New Substances Added into the Candidate List of SVHCs

 

On January 15, 2019, ECHA added 10 new substances to the Candidate List of substances of very high concern (SVHCs). The authorization now contains 197 substances. The new substances to the Candidate List possess the carcinogenic, toxic to reproduction, persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) properties.

 

Following are the substances included in the Candidate List for authorization on 15 January 2019 and their SVHC properties:

 

# Substance Name EC Number CAS Number Reason for Inclusion Examples of Use(s)
1 2,2-bis-(4′-hydroxyphenyl)

-4-methylpentane

401-720-1 6807-17-6 Toxic for reproduction (Article 57c) No active registrations under REACH
2 Benzo[k]fluoranthene 205-916-6 207-08-9 Carcinogenic (Article 57a) Not yet registered under REACH
PBT (Article 57d)
vPvB (Article 57e)
3 Fluoranthene 205-912-4 206-44-0 PBT (Article 57d) Not yet registered under REACH
vPvB (Article 57e)
4 Phenanthrene 201-581-5 85-01-8 vPvB (Article 57e) Not yet registered under REACH
5 Pyrene 204-927-3 129-00-0 PBT (Article 57d) Used as a transported intermediate for the manufacture of fine chemicals
vPvB (Article 57e) 
6 1,7,7-trimethyl-

3-(phenylmethylene)-bicyclo[2.2.1]heptan-2-one 

239-139-9 15087-24-8 Endocrine disrupting properties (Article 57(f) – environment) Not yet registered under REACH

 

O-TEX® Standard 100 – 2019

On January 2, 2019, the OEKO-TEX® Association updated the applicable test criteria and limit values for product certification in accordance with the STANDARD 100 by OEKO-TEX®. The following new regulations will come into force on April 1, 2019 for all certifications, following a three-month transition period.

 

The main amendment is as follows:

 

  1. In 2019, OEKO-TEX® already complies with the new “REACH Annex XVII CMR Legislation”.

 

The substance benzene and four amine salts have been included in the STANDARD 100 by OEKO-TEX® and LEATHER STANDARD by OEKO-TEX® and limit values have been defined. The substance quinoline is also regulated with a limit value. In the course of “standardization” of the limit value requirements, the requirement “<” now applies for almost all limit values.

 

  1.  Four new substances of very high concern added to the limit value catalogues

 

The limit value catalogues add four Substances of Very High Concern: the siloxanes D4, D5 and D6 as well as diazene-1, 2-dicarboxamide (ADCA). Furthermore, a requirement has now been made with regard to the extractable part of the metals barium and selenium. In Annex 6 of the STANDARD 100 by OEKO-TEX®, limit values have been made stricter for various parameters, which relates to the parameters for phthalates (softeners), alkylphenols and alkylphenol ethoxylates as well for per- and polyfluorinated compounds.

 

  1.  In 2019, two new product groups will be under observation: glyphosate and its salts as well as the carcinogenic N-nitrosamines and N-nitrosatable substances.

ECHA Consults on Amendment of REACH 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.