June 2017 Regulatory Update

NORTH AMERICA NEWS

US CPSC Proposes Rule to Adopt Booster Seats Standard

On May 19, 2017, the US Consumer Product Safety Commission (CPSC) issued proposed rule 16 CFR 1237 in Federal Register 82 FR 22925 regarding the safety standard adoption for Booster Seats.

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In the proposed rule, the newly published ASTM F2640-17e1 Standard Consumer Safety Specification for Booster Seats was adopted in order to reduce the chance of injury associated with booster seats which are defined as:

  1. A juvenile chair, which is placed on an adult chair to elevate a child to standard dining table height
  2. Made for the purpose of containing a child, up to 5 years of age, and normally for feeding or eating
  3. A booster seat that may be height adjustable and include a reclined position

The proposed rule is currently under comment period until August2, 2017.


US EPA Delays Implementation of Composite Wood Products Formaldehyde Standard

On May 24, 2017, the Environmental Protection Agency (EPA) issued Final Rule 82 FR 23735 to delay the implementation of 21 CFR Part 770 “Formaldehyde Emission Standards for Composite Wood Products”. The Final Rule 21 CFR 770 was approved and published in the Federal Register on December 12, 2016 to implement standards to reduce formaldehyde emissions as required by the Compliance Monitoring Strategy of the Toxic Substances Control Act (TSCA) (See Story in Regulatory Recap: January 2017).

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The implementation timeline is summarized below:

Item Current Implementation
Date
Proposed Implementation
Date
Emission standards, recordkeeping and
labelling provisions
December 12, 2017 March 22, 2018
Import certification provisions December 12, 2018 March 22, 2019
Conclusion of transition period for CARB
Third-Party Certifiers (TPCs)
Provisions applicable to producers of
laminated products
December 12, 2023 March 22, 2024

The Final Rule will be effective on July 10, 2017 unless the EPA receives any adverse comment by June 8, 2017.


US EPA Issues Notices Related to TSCA Findings on New Chemicals

On April 25, 2017, the Environmental Protection Agency (EPA) issued two notices, 82 FR 19044 and 82 FR 19046. The EPA reports findings on new chemical substances or significant new uses that are not likely to present an unreasonable risk of injury to health or the environment.

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The EPA is required under TSCA section 5(g) to publish in the Federal Register a statement of its findings after its review of a TSCA section 5(a) notice when the EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. The two notices present statements of findings during December 2016 and February 2017 separately. The case numbers and the chemical substances that were reviewed are listed below:

Notices EPA Case
Number
Chemical Identity
82 FR 19044
Statement of
findings during
December 2016
J-16-0033 Saccharomyces cerevisiae modified to express glucoamylase activity (generic name)
J-16-0034 Saccharomyces cerevisiae modified (generic name)
J-16-0035 Saccharomyces cerevisiae modified (generic name);
J-16-0036 - 0041 Biofuel producing modified microorganism(s), with chromosomally-borne modifications (generic name)
P-17-0009 Depolymerized waste plastics (generic name)
P-17-0016 Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated (generic name)
P-17-0017 Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated (generic name)
P-17-0018 Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, Azobis [aliphatic nitrile] initiated (generic name)
P-17-0019 Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated (generic name)
P-17-0020 Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated (generic name)
P-17-0021 Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, Azobis [aliphatic nitrile] initiated (generic name)
82 FR 19046
Statement of
findings during
February 2017
J-17-0001-0005 Saccharomyces cerevisiae modified (generic name)
J-17-0006 Saccharomyces cerevisiae modified (generic name)
P-17-0144 Amines, C36-alkylenedi-, polymers with octahydro-4,7-methano-1H-indenedimethanamine and pyromelliticdianhydride, maleated (CAS Number: 2020378-57-6)
P-17-0158 Perylenebisimide (generic name)
P-17-0160 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide and alkyl 2-propenoate (generic name)
P-17-0161 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide, ethenylbenzene and alkyl 2-propenoate (generic name)
P-17-0182 Alkyldioic acid, polymer with 2,2-dimethyl-1,3-propanediol, heteropolycycliccarboxy acid anhydride and 1,3-propanediol (generic name)
P-17-0185 Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with C18-unsatd. fatty acid trimers, alkylenediamine and hydroxyalkanoic acid (generic name)

Updates of ASTM Standards

Below is a summary of recently updated ASTM standards:

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CPSIA /
CFR
Reference
ASTM Standard
No.
Detail
- ASTM F2640-17e1 Standard Consumer Safety Specification for Booster Seats
Covers the performance requirements and methods of test to
ensure the satisfactory performance of the booster seat.
- ASTM F1148-17 Standard Consumer Safety Performance Specification for Home
Playground Equipment

Provides safety requirements for various types of home playground
equipment intended for use by children aged from over 18 months
through 10 years. It further provides requirements for swings
intended specifically for toddlers.

US State of California OEHHA Intends to List Pentabromodiphenyl Ether Mixture under Proposition 65

On May 5, 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice that Pentabromodiphenyl Ether Mixture [DE-71 (technical grade)] is intended to be listed under Proposition 65 as known to the State to cause cancer.

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The chemical details are provided below:

Chemical Chemical Abstracts Service
Number (CAS No.)
Types of Toxicity
Pentabromodiphenyl Ether Mixture
[DE-71 (technical grade)]
32534-81-9 Cancer

The comment period for listing of Pentabromodiphenyl Ether Mixture intention ended on June 5, 2017.


California Proposition 65: Recent 60-Day Notices

In 1986, California voters approved an initiative titled California Proposition 65 to address their growing concerns about exposure to toxic chemicals. Since its origin, there have been many lawsuits that have resulted in reformulations of consumer products containing carcinogenic and reproductively harmful chemicals on the Cal Prop 65 list.

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Recent 60-day notices from April to May of 2017 include the following:

Chemical Product / Source Number of
Notices
Acrylamide Foods 2
Bisphenol A (BPA) Thermal Paper / Measuring Cup 15
Cadmium Cacao Nibs / Cacao Bar/ Smoked Oysters 3
Cadmium and cadmium
compounds, Lead and lead
compounds
Food powder 2
Dietary Supplements 1
Di(2-ethylhexyl)phthalate (DEHP) Armband 2
Bag / Cooler Bag / Purse / PVC Backpack 9
Body Mist Set / Folding Chairs /
Hand tools / Hanger
12
Headphones / Hose / Jump Rope / Lunchbox 9
Shower Curtain / Suction cup / Sunglasses 6
Vinyl products: Floor Mat/ Raincoats/ Sleeve/
Electronics Cases/ Footwear/ Tubing
15
Di(2-ethylhexyl)phthalate (DEHP),
Di-isodecyl phthalate (DIDP),
Diisononyl phthalate (DINP)
Cables 1
Di(2-ethylhexyl)phthalate (DEHP),
Di-isodecyl phthalate (DIDP), Di-
n-butyl phthalate (DBP),
Diisononyl phthalate (DINP)
Hangers 1
Di(2-ethylhexyl)phthalate (DEHP),
Di-isodecyl phthalate (DIDP), Di-
n-butyl phthalate (DBP),
Diisononyl phthalate (DINP)
Hose/ Wallet/ Cable/ Mats 4
Di(2-ethylhexyl)phthalate (DEHP),
Di-isodecyl phthalate (DIDP), Di-
n-butyl phthalate (DBP),
Diisononyl phthalate (DINP)
Vinyl Mat/ Nipper/ Key Topper 2
Di(2-ethylhexyl)phthalate (DEHP),
Lead
Hand tools/ Belts 2
Di-isodecyl phthalate (DIDP) Connectors/ Growler filler 2
Di-isodecyl phthalate (DIDP),
Diisononyl phthalate (DINP)
Pencil Pouch 1
Diisononyl phthalate (DINP) Armband/ Bag/ Cable/ Chair Cover/
Headphones
17
Vinyl Tubing / Tape 5
Di-n-butyl phthalate (DBP) Sandals / Lock 4
Lead Adapters / Calipers/ Flowmeters/ Deflators/
Injectors/ Regulators
19
Brass fittings/parts 8
Dietary Supplements/ Food 47
Footwear / LED lightings/ Pasta makers/ Valve 11

US State of Oregon Issues Exemptions Guidance on the High Priority Chemicals of Concern Reporting Rule

Beginning January 1, 2018, manufacturers of children’s product sold in the State of Oregon are required to report to the Oregon Health Authority (OHA) if their products contain one or more of 66 High Priority Chemicals of Concern for Children’s Health (HPCCCH) which are at or above the de minimis level. As the reporting date is coming close, a guidance related to exemption has been issued by the OHA to assist manufacturers.

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Instead of notifying the OHA, a manufacturer may alternatively submit a request for the reporting exemption if a children’s product contains a HPCCCH as a contaminant at or above the de minimis level. In order to be approved for the exemption, manufacturers must also demonstrate that the contaminant is effectively controlled under a Manufacturing Control Program (MCP). To make it clear, the guidance explains the elements of a MCP that the OHA will evaluate. They include:

  1. Manufacturer name, mailing address, contact information
  2. Manufacturer should specify if they believe that any confidential business records or trade secrets are included in the MCP
  3. The HPCCCHs covered by the MCP
  4. Description of the product and description of how and when in the process the HPCCCH is generated
  5. Categories MCP is being structured around (manufacturing processes, materials or groups of materials, component parts, or finished products)
  6. Description of the mechanisms covered by the MCP
  7. Information of best manufacturing practice and process (generally recognized in the industry) that the MCP meets
  8. Document and describe manufacturing control practices and processes from point #7

In addition, the OHA will accept exemption requests beginning June 28, 2017.


EUROPE NEWS

EU Adopts Amendments to lower the Limit of BPA and add Limit of Phenol

In May 2017, the European Union (EU) issued and approved Directive (EU) 2017/774 and Directive (EU) 2017/898 to amend the Toy Safety Directive 2009/48/EC in adding a new requirement for Phenol and lowering the limit of Bisphenol A (BPA)

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In Directive (EU) 2017/774, the following new entry regarding the limit of phenol will be added to Annex II (Appendix C) of Directive 2009/48/EC:

Limit of Phenol
In polymeric material As preservative
Migration limit 5 mg/L -
Content limit - 10 mg/kg

Beginning from November 4, 2018, toys intended for use by children under 36 months and other toys intended to be placed in the mouth will be subject to the above phenol requirements.


In addition, Directive (EU) 2017/898 made the following changes in the same section of Directive 2009/48/EC regarding the migration limit of BPA:

Migration Limit of BPA
Current limit 0.1 mg/L
Amended limit 0.04 mg/L
The new limit will be effective on November 26, 2018.

EU Amends Food Contact Plastics Regulation

On April 29, 2017, the European Union (EU) approved and published Commission Regulation (EU) 2017/752 to amend Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food.

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Upon implementation of the amendment regulation on May 19, 2018, the following changes to the food contact plastic regulation will be implemented:

  1. Updated list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer product aids to:
    1. Include 6 new entries of substances
    2. Remove verification of compliance by residual content per food contact surface area for 10 substances
  2. Transformed food simulant assignment for testing overall migration into table form for clarity (Technically unchanged)
  3. Updated information required for the declaration of compliance

Upon implementation of the amendment regulation on May 19, 2019, the following changes on food contact plastic regulation will be implemented:

  1. Add new specific migration limits (0.02mg/kg food or food simulant) for Nickel

EC Publishes Guidance to RED

On May 19, 2017, the European Commission (EC) published the Guidance to Directive 2014/53/EU Radio Equipment Directive (RED), which has been implemented since June 13, 2016.

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The guidance document is based on the RED and the new legal framework described in the “Blue Guide 2016”. In conjunction to the Blue Guide, the guidance explains clearly the definition of radio equipment and provides examples which are excluded from the scope of the RED. The guidance also lists out and provides further information on the obligations of different economic operators, such as manufacturer, importer and distributor.

Other than the definition and obligations, the guidance addresses the essential technical requirements applicable to all and other specific types of radio equipment separately and provides a comparison between the current RED and the repealed Radio Equipment and Telecommunications Terminal Equipment Directive (R&TTED).


Europe Recalls Summary (April and May 2017)

In Europe, when hazards are identified in consumer products, the products will be recalled and published in the Rapid Alert System, which is updated weekly. The European recalls for April and May 2017 are summarized below:

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Hazard Frequency
Chemical Hazard 71
Choking Hazard 69
Electric Shock Hazard 40
Injury Hazard 29
Strangulation Hazard 15
Burn Hazard 12
Hearing Hazard 10
Other Hazards* 34

* Other Hazards include Asphyxiation Hazard, Cut Hazard, Entrapment Hazard, Fire Hazard, Environmental Hazard, Microbial Hazard, Sight Hazard and Suffocation Hazard with a frequency of less than 10.


Product Categories Frequency
Toys and Childcare Articles 115
Fabric / Textile / Garment / Home Textile 33
Cosmetics / Bodycare 30
Lighting 24
Computer / Audio / Video / Other Electronics & Accessories 10
Other Categories^ 40

^ Other Categories include Candles & Burning Items and Accessories, Consumer Chemicals, Footwear, Furniture, Home Electrical Appliances (Hair Dryer, Iron, etc.), Jewelry, Watch or other Fashion Accessories, Personal Protective Equipment (excludes eye protection), Sporting Goods / Equipment and Tools and Hardware,with a frequency of less than 10.

Download the complete Recalls Summary – EU (April and May 2017)


AUSTRALIA NEWS

Australia Adopts Updated Safety Standard for Babies’ Dummies and Dummy Chains

On April 18, 2017, the new Consumer Goods Safety Standard 2017 related to children’s nightwear and limited day daywear entered into force. The safety standard adopts updated standard AS/NZS 1249: 2014 Children's Nightwear and Limited Daywear Having Reduced Fire Hazard and will revoke previous regulations published in 2007.

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The key updates of the requirements are summarized below:

>
Item Mandatory Standards Requirements
Babies’ dummies
(Either one, EN or
AS, standard shall
be applied)
AS 2432:2015 – Babies dummies - General requirements
- Size and integrity of dummy shield
- Strength of the teat
- Size and integrity of the ring, handle and plug
- Decoration
- Packaging
- Product information
EN 1400:2013+A1:2014 - Child use and care
article – Soothers for babies and young
children – Safety requirements and test
methods
Dummy chains EN 12586:2007+A1:2011 - Child use and care
articles – Soother holder – Safety
requirements and test methods
- Decoration
- Length
- Impact resistance
- Durability of the garment fastener
- Tensile strength

The updated requirements are currently under a transition period until July 1, 2019. Therefore, products may comply with either the current or updated standard during this period. However, the updated standards will become mandatory after the transition.


ASIA NEWS

Malaysia Updates Food Contact Ceramics Requirements

On April 3, 2017, Food (Amendment) No. 2 Regulations 2017 was published through the Federal Government Gazette. The Regulation amends the Food Regulation 1985 and updates the food contact ceramics requirements.

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The key changes of the Food Regulations are summarized below:

  1. Updates the migration limit of Cadmium (Cd) for:
  2.   Migration Limit of Cadmium in
    small hollow-ware
    Migration Limit of Cadmium
    in large hollow-ware
    Previous limit 0.20 mg/L 0.20 mg/L
    Amended limit 0.50 mg/L 0.25 mg/L
  3. Updates the adopted test method standards
  4.   Standard
    Previously adopted standard MS 1817-1 Ceramic Tableware - Specification
    Amended adopted standard MS ISO 6486-1 Ceramic Ware, Glass Ceramic Ware
    And Glass Dinnerware In Contact With Food -
    Release Of Lead And Cadmium – Part 1: Test
    Method

The amendment regulation has been in effect since April 15, 2017.


HKSAR Updates Certain Adopted Toys and Children’s Products Safety Standards

On May 19, 2017, the Hong Kong Administrative Region (HKSAR) Government published in the Gazette the Toys and Children’s Products Safety Ordinance (Amendment of Schedules 1 and 2) Notice 2017. The notice amends the Toys and Children’s Products Safety Ordinance (Cap. 424) to update certain adopted safety standards.

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The specified standards for toys and various products have been updated to new versions. Meanwhile, two new toys standards will be added upon enforcement. The key changes are summarized below:

Product Repealed Version Updated Version
Toys Standards
Finger paints - ISO 8124-7:2015
Chemical toys (sets) other than
experimental sets
BS EN 71-5:2013 BS EN 71-5:2015
Olfactory board games,
cosmetic kits and gustative
games
- BS EN 71-13:2014
Electric toys BS EN 62115:2005+A11:2012 BS EN 62115:2005+A11:2015
Products Standards
Bunk beds and high beds BS EN 747-1:2012 BS EN 747-1:2012+A1:2015
BS EN 747-2:2012 BS EN 747-2:2012+A1:2015
Expansion gates and expandable enclosures ASTM F1004-13 ASTM F1004-16b
High chairs ASTM F404-14a ASTM F404-16a
Children’s high chairs ISO 9221-1:1992 ISO 9221-1:2015
Non-full-size baby cribs / play yards ASTM F406-13 ASTM F406-15
Carriages and Strollers ASTM F833-13b ASTM F833-15

The updated standards will be effective on April 1, 2018.


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