May 2018 Regulatory Update

NORTH AMERICA NEWS

Updates of ASTM Standards

Below is a summary of recently updated ASTM standards:

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ASTM Standard
No.
Detail
ASTM F2388-18 Standard Consumer Safety Specification for Baby Changing Products for Domestic Use
Covers performance requirements, test methods, and labeling requirements to promote the safe use of baby changing products including changing tables, changing table accessories, contoured changing pads, and add-on changing units.
ASTM F404-18 Standard Consumer Safety Specification for High Chairs
Covers the performance requirements and methods of testing to ensure the satisfactory performance of the high chair and high chairs created by using a high chair conversion kit and component(s) from another product.
ASTM F2670-18 Standard Consumer Safety Specification for Infant Bath Tubs
Establishes performance requirements, test methods, and labeling requirements to promote the safe use of infant bath tubs. It also covers slings, pads, inserts and similar accessories when such accessories are used with the infant bath tub.
ASTM F2670-18 Standard Consumer Safety Specification for Infant Bath Tubs
Establishes performance requirements, test methods, and labeling requirements to promote the safe use of infant bath tubs. It also covers slings, pads, inserts and similar accessories when such accessories are used with the infant bath tub.
ASTM F2012-18 Standard Consumer Safety Performance Specification for Stationary Activity Centers
Covers performance requirements, test methods and marking requirements to promote the safe use of a stationary activity center by an occupant.

US CPSC Grants Petition and Issues Guidance Regarding Labeling of Household Products Containing Methylene Chloride

On March 21, 2018, the Consumer Product Safety Commission (CPSC) granted a petition and issued guidance through the Federal Register, 83 FR 12254, to update the Statement of Interpretation and Enforcement Policy regarding the labeling of household products containing methylene chloride (DCM).

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In 2016, the petitioner, Halogenated Solvents Industry Alliance, Inc., asked the CPSC to expand the policy statement to address the need for an acute hazard warning label on household products containing methylene chloride that are readily available for consumers to purchase and use (See Regulatory Recap: September 2016).On June 2, 2017, the CPSC voted unanimously (5-0) to grant the petition and the guidance was issued recently to address the labeling for acute hazards from inhaling methylene chloride vapors from paint strippers. The labeling will follow the general principles of warning labels by having the acute and chronic risks conveyed on the principal display panel following the minimum labeling recommendations and on the back or other panel following the minimum labeling recommendations.


US FTC Approves to Eliminate Certain Word Trademark Requirements in Textile Rules

The US Federal Trade Commission (FTC) issued a final rule in Federal Register, 83 FR3068, regarding an amendment to 16 CFR 303 Rules and Regulations Under the Textiles Fiber Products Identification Act. This final rule entered into force on February 22, 2018.

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In the final rule, the FTC amends 16 CFR 303.19, paragraph (a),to eliminate the requirements that an owner of a registered word trademark furnish the FTC with a copy of the mark’s registration with the United States Patent and Trademark Office (USPTO) before using the mark on labels.


US CPSC Issues Draft Guidance for Determining Age Appropriateness of Toys

On March 27, 2018, the Consumer Product Safety Commission (CPSC) published notice in Federal Register, 83 FR 13121, to issue draft age determination guidelines, Guideline for Determining Age Appropriateness of Toys (March 2018), for comment.

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With the input from the Child and Family Research Section staff at the National Institute of Child Health and Human Development (NICHD) within the National Institutes of Health (NIH), the CPSC staff revised the current age determination guidelines (version 2002) and issued the new drafted guideline based on literature review, parent toy survey and observational study. The drafted guideline addresses toys that have come onto the market since the last update and provide the industry a better guideline to reduce product related incidents, costly compliance and enforcement actions.

The comment period for the draft guidance will be closed on June 11, 2018.


US CPSC and Health Canada Issue Draft Guidance on the Application of Human Factors to Consumer Products

On March 15, 2018, the Consumer Product Safety Commission (CPSC) published notice in Federal Register, 83 FR 11508, to issue draft guidance written by the CPSC and Health Canada, Guidance on the Application to Human Factors to Consumer Products, for comment.

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The draft guidance provides recommendations to consumer product industry stakeholders, designers and manufacturers to improve their products’ usability, which aims to reduce the use-related hazards. Many product-related injuries can be prevented by better user-centered design. The document also discusses the benefits of employing human factors during the product design process, which is divided into the following six stages:

  1. Product planning
  2. Idea and concept generation
  3. Design and development
  4. Testing and validation
  5. Production
  6. Post-production evaluation

The comment period for the draft guidance will be closed on May 14, 2018.


US State of California Judge Approves Settlement Covering Proposition 65 Warnings

On February 14, 2018, the San Francisco Superior Court judge approved a settlement of a lawsuit, Case number CGC-15-548791, alleging that nine manufacturers of chocolate products made items containing cadmium and lead in an amount above the safe harbor level limits. The settlement requires the manufacturers to provide Proposition 65 warnings based on the levels of the two chemicals.

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In the settlement, a chocolate product is defined as chocolate candy, chocolate bars, pieces, chips, beverages and chocolate and cacao-based compounds in any form and other products derived primarily from cacao (i.e. more than 50%).The below table summarizes the minimum concentration of lead and cadmium present in chocolate products that require a product warning:

Covered Product Lead Concentration Cadmium Concentration
Chocolate products with up to 65% cacao content 0.1 ppm 0.4 ppm
Chocolate products with greater than 65% and up to 95% cacao content 0.15 ppm 0.45 ppm
Chocolate products with greater than 95% cacao content 0.225 ppm 0.96 ppm

California Proposition 65: Recent 60-Day Notices

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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. Prior to legal action, a 60-day Notice is served to provide an opportunity for public enforcers to decide whether they should pursue the action in lieu of private enforcement. It also provides the alleged violator an opportunity to consult with an attorney, respond to the alleged violation, and help prevent continuing penalties.

60-day notices from September of 2017 to March of 2018 include the following:

Chemical Product / Source Number of Notices
1,1-Dichloro-2,2-bis(p-chloropheny)ethylene (DDE), 1,1-Dichloroethane, 1,4-Dioxane, Arsenic (inorganic arsenic compounds), Arsenic (inorganic oxides), Benzene, Bromodichloromethane, Cadmium, Carbon disulfide, Carbon tetrachloride, Chloroethane (Ethyl chloride), Chloroform, Chromium (hexavalent compounds), DDE (Dichlorodiphenyl-dichloroethylene), Ethylbenzene, Lead, Mercury, Polychlorinated biphenyls, styrene, Tetrachloroethylene (Perchloroethylene), Toluene, Trichloroethylene, Vinyl chloride Drinking Water Supply 1
1,1-Dichloroethane Wallet 1
1,4-Dioxane Shampoo / Body Lotion / Body Cleanser 2
Acrylamide Food 24
Arsenic (inorganic arsenic compounds) Food 1
Supplements 1
Arsenic (inorganic arsenic compounds), Arsenic (inorganic oxides), Lead Supplements 1
Arsenic (inorganic arsenic compounds), Cadmium, Lead Food 1
Arsenic (inorganic arsenic compounds), Lead and lead compounds Supplements 1
Benzophenone Sunscreen 2
Bisphenol A (BPA) Computer Case 1
Food Contact Material 13
Helmet 1
Thermal Paper 4
Sunglasses 1
Phone Cases 2
Soap Holders 1
Cadmium Food 1
Supplements 3
Belts 1
Jewelry 1
Cadmium and cadmium compounds, Lead and lead compounds Food 5
Cadmium, Lead Food 13
Cadmium, Lead and lead compounds Food 5
Supplements 27
D&C Orange No. 17, Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP) Plastic Sandals with Polymer Strap 1
Di(2-ethylhexyl)phthalate (DEHP) Apparel / Jacket / Belts / Pillow / Apron 6
Armbands / AnkleWrap / HandWrap 9
Armrest Pads / Knee Pads 2
Baby Seat / Baby Care Kit 2
Backpack / Bags and Accessories 105
Badge Holders / Card Holders 3
Bath Mat / Activity Mats / Cutting Mat /Place Mats / Trapper Mat / Box Mat / Sink Mat 16
Covering (includes Greenhouse, Table, Pillow etc.) 36
Curtain / Curtain Liner 7
Dog Collar / Pet Toys / Pet Stroller / Pet Carrier / Pet Bowls 2
Earmuff 4
Essential Oils 3
Eyewear / Sunglasses / Reading Glasses / Safety Glasses 16
Fabric Snap-In Liner 1
Fitness Balls / Fitness Foam Rollers / Dumbbells / Jumping Rope /Reflective Sports Gear 6
Flotation Device 1
Food Contact Material 6
Foot Care System / Foot Treatment 1
Funnel 1
Furniture 1
Gloves 11
Hair Accessories 2
Headphone Cords 7
Headphones 19
Hot/Cold Therapy Bag 1
Laptop Cover 3
Lubricants 1
Luggage Tag / Luggage Locks / Passport Holder 5
Mirror 1
Musical Instrument Handle 2
Paint Sets 1
Portfolios 2
Power Bank 1
Pressure Gauge 1
Rope 2
Safety Pad / Safety Straps / Safety Vests 4
Shoes / Flip Flops / Sandals / Plastic Flats / Insole 8
Shower Curtain / Shower Curtains with pockets 2
Plastic Sleeves 3
Soap Holders / Tissues Holders 5
Sole Scrubber 1
Tape 12
Tape Measure 1
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 53
Travel Set 14
Tray 2
Padded Check Holders 1
Wallet 7
Wand 2
Wrap Case 2
Cosmetic Case / Cosmetic Tote / Cosmetic Set / Brow or Lashes Set / Eyelash Curler / Shampoo / Shaving Cream / Body Lotion / Body Cleanser 10
Phone Cases / Phone Stands 4
Battery Clamp Handles / Bin Handles / Camera Recorder / Camp Shower Bag / Closet Container Cooling Vest / Cord Holder 8
Decorations / Door Flap 2
Fishing Lures / Fishing Rod Holder 3
Glue Gun / Hammers / Hangers / Hooks 11
Hose Grips / Shower Hose / Sprayer Hose 6
Storage Hooks / Organizer / Boxes / Bin Handles / Suction Hooks 17
Stationary / Stickers / Non-slip Sticker 7
Adapters / Electrical Wires / Extension Cords / Flashlights / HDMI Cables / Wires Strippers 15
Jewelry / Jewelry Organizer / Keychains 3
Rain Boots / Rains Coats / Rain Gauges / Umbrella 4
Di(2-ethylhexyl)phthalate (DEHP), Di-isodecyl phthalate (DIDP) Flip Flops 1
Di(2-ethylhexyl)phthalate (DEHP), Di-isodecyl phthalate (DIDP), Diisononyl phthalate (DINP) Fishing Lures 1
Furniture Repair Markers 1
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP) Fishing Lures 1
Headphone Cords 1
Travel Set 1
Tray 1
Bags and Accessories 7
Wheel Covers 1
Hose 1
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), Lead and lead compounds Fishing Lures 1
Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP) Anti-Stress Comfort Wrap 2
Suction Hooks 1
Children's Backpack 1
Sandals 6
Bath Stool 1
Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP), Diisononyl phthalate (DINP) Bags 1
Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP), Lead Screwdrivers / Hammers 3
Hoses / Electrical Components and Accessories / Flashlights / Hand Tools / Household Hardware Accessories / Tape Measures 1
Di(2-ethylhexyl)phthalate (DEHP), Lead Lantern Handles 1
Lighting 1
Bags 1
Screwdrivers / Tape Measure 2
Dibenzo[a,e]pyrene Phone Cases 1
Diethanolamine Consumer Chemicals 2
Food 1
Foot Care System / Foot Treatment 1
Pain Relieving Cream 4
Facial Serum / Facial Sunscreen / Curl Enhancer / Hand Cleaner 6
Body Lotion / Shaving Cream / Hair Gel / Sunscreen 12
Di-isodecyl phthalate (DIDP), Diisononyl phthalate (DINP) Fishing Lures 2
Bags and Accessories 3
Tools - Pliers 1
Diisononyl phthalate (DINP) Armbands / Ankle Wrap / Hand wrap 7
Clutch 2
Consumer Chemicals 1
Containers 1
Earmuff 1
Earwax Removal Kit 2
Fishing Lures 7
Furniture 2
Headphones 3
Pillow 1
Shower Curtain / Shower Curtain with pockets 2
Tow Strap 1
Bags 16
Bath Mat 2
Body Lotion 2
Card Holders 1
Charger / Car Charger 2
Curtain / Covering 9
Fitness Balls / Jumping Rope 2
Garden Tools / Other Tools 7
Hair Accessories / Gloves 6
Travel Set / Luggage Tag / Packaging 5
Pet Toys / Pet Stroller / Pet Carrier / Pet Bowls 4
Power Bank / USB Cords / Remote Control / Electrical Wires / Extension Cords 11
Rains Coats/ Umbrella 2
Di-n-butyl phthalate (DBP) Belts 1
Shoes / Flip Flops / Sandals / Plastic Flats 14
Sheet Straps 1
Formaldehyde (gas) Electronic Cigarette Devices 1
Apparel 1
Furfuryl Alcohol Food 5
Lead Air Gun Tips 1
Calipers 4
Dumbbells 2
Finials 1
Food 49
Food Contact Material 22
Lotion Dispenser 1
Lubricants 1
Sheet Straps 1
Supplements 6
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 108
Adapters / Battery Clamp Handles / Computer Cable Locks 6
Belts / Badge Holders 2
Faucets / Faucets Locks / Hose ends / Sprayer Hose / Sprinklers 5
Fidget Spinner 1
Rain Gauges 1
Stationary / Stickers 3
Lighting / Sockets 3
Locks / Luggage Locks 4
Lead and lead compounds Fidget Spinner 1
Food 19
Food Contact Material 2
Lead-based Ammunition 1
Stethoscope 1
Supplements 31
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 12
Hose 2
Lead and lead compounds, Propargite Supplements 1
Malathion Food 2
Insect Control / Spray 6
Tris(1,3-dichloro-2-propyl) phosphate (TDCPP), Tris(2-chloroethyl) phosphate Foam Padding 1

SOUTH AMERICA NEWS

Colombia Minister of Health and Social Protection Approves New Toys Safety Regulation

On March 5, 2018, the Ministry of Health and Social Protection published Resolution 686/2018 to establish new safety regulations for toys and their accessories manufactured, imported and marketed in Colombia.

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The requirements for toys in the resolution are summarized below (with the corresponding test standards):

Requirements Compliance Standard Other standards that are accepted as equivalent
Mechanical and Physical Properties NTC-EN 71-1, Safety of Toys, Part 1, Mechanical and Physical Properties. EN 71-1
ASTM F963
ISO 8124-1
Flammability NTC-EN 71-2, Safety of Toys, Part 2, Flammability. EN 71-2
ASTM F963
ISO 8124-2
Migration of Heavy Metal (19 heavy metals) NTC-EN-71-3, Safety of Toys, Part 3, Migration of Certain Chemical Elements. EN 71-3

The resolution will enter into force on March 5, 2019. During the transition period, toys and their accessories shall comply with the current requirements established in Resolution 3388/2008 and Resolution 3117/2015. Both Resolutions 3388/2008 and Resolution 3117/2015 will be repealed after the enforcement date of the new toys safety regulation.


EUROPE NEWS

ECHA Proposes to Restrict New Phthalate in Plasticized Materials

On March 28, 2018, the European Chemical Agency (ECHA) proposed to amend Annex XVII, List of Restriction, of Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through World Trade Organization (WTO) notification, G/TBT/N/EU/564. It is proposed to include Diisobutyl Phthalate (DIBP) into the current phthalates restriction, which has been agreed to and supported by the committee of Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) (See Regulatory Recap: April 2017).

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In the proposed amendment, DIBP is added to entry 51 of the list of restriction and the scope for DEHP, DBP and BBP (together with DIBP) is expanded to any plasticized materials except the below:

  • Articles used exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticized material comes into contact with human mucous membranes or prolonged contact with human skin
  • Aircraft, or motor vehicles within the scope of Directive 2007/46/EEC
  • Measuring devices for laboratory use, or parts thereof
  • Food contact materials and articles within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EC) No10/2011
  • Medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or98/79/EC, or parts thereof
  • Electrical and electronic equipment within the scope of Directive 2011/65/EU (RoHS)
  • Immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC

The proposed amendment also defined “plasticized materials” as the following homogeneous materials:

  • Polyvinyl chloride (PVC), other polymers such as polyvinylidene chloride (PVDC) and polyvinyl acetate (PVA), as well as any other plastics, except polyolefins
  • Rubber, except silicone rubber and natural latex coatings
  • Polyurethanes and any other foam rubber or foam plastic
  • Surface coatings, non-slip coatings, finishes, decals, printed designs
  • Adhesives, sealants, paints and inks

The new amendment will be implemented 18 months after the proposal has entered into force. The deadline for comments on the proposal is May 27, 2018.



ECHA Issues Guidance for REACH PAH Restriction

On March 7, 2018, the European Chemical Agency (ECHA) issued a Guideline on the Scope of Restriction, Polycyclic Aromatic Hydrocarbons (PAHs) under Entry 50 of Annex XVII, List of Restriction, in Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

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To assist producers, importers and distributors in complying with the PAHs restriction under REACH, a guideline was published to provide a clear definition of the products that are within the scope (See Regulatory Recap: March 2017).

Generally according to the guideline, PAHs in consumer products including toys may be found in the following sources:

  1. Use of mineral oil or coal-based extender or plasticizer oils in the production of rubber and plastics
  2. Carbon black (soot), which is intentionally added to elastomers to achieve the properties of the material (Examples include: color, damping, flexibility, or solubility in the polymer matrix)
  3. Plastic materials, lacquers or varnishes
  4. Coatings (Example: plastic coating made of synthetic organic polymers)

Apart from the sources, examples of articles within or excluded from the scope are also listed.


SASO NEWS

Saudi Ministry of Commerce and Investment (MCI) Inspection Teams Find Lighting Items Not Complying with Energy Efficiency Specifications

MCI has carried out inspections on 55 lighting stores to verify the commitment of traders and importers to the Saudi standard specifications related to lighting energy efficiency.

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The inspection, which took place in Riyadh, Jeddah and Dammam, resulted in the confiscation of 126 lighting models that did not meet the standard specifications of energy efficiency. Therefore, all the sub-standard products, amounting to 90,884 items, were seized by MCI inspectors.

This inspection came within the framework of the efforts exerted by several governmental authorities, operating as one team within the Saudi Program for Energy Efficiency. The Saudi Program for Energy Efficiency works to ensure the commitment and compliance with the standard specifications related to increasing the efficiency of energy consumption. Notably, the program is run by various governmental authorities, including:

  • The Ministry of Commerce and Investment
  • The Ministry of Energy, Industry and Mineral Resources
  • The Saudi Standard, Metrology and Quality Organization
  • The General Authority of Customs
  • The Saudi Center for Energy Efficiency

For more details, please visit: https://mci.gov.sa/en/MediaCenter/News/Pages/15-04-18-01.aspx


Saudi Ministry of Commerce and Investment (MCI) Inspection Teams Carry Out 2,243 Inspection Tours on Two-Riyal Shops. 14,000 Commodities Seized and 200 Violation Notices Issued

An MCI field inspection campaign on Two-Riyal, Five-Riyal and Ten-Riyal Shops resulted in carrying out 2,243 inspection tours, seizing and confiscating 14,000 fake goods, and issuing 200 violation notices. The owners were summoned by MCI in accordance with the Anti-Commercial Fraud Law. Offering any fake and counterfeit products is considered a violation that leads to a fine of up to one million riyals and/or imprisonment for up to three years in addition to the defamation against the violators in the local newspapers.

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The violations included the following:

  • Non-compliance with the Anti-Commercial Fraud Law
  • Forging registered trademarks
  • Failure to place a price tag on the products
  • Non-disclosure of trade data of the goods
  • Non-issuance of purchase invoices
  • Invoices not written in Arabic
  • Violations related to the Commercial Data System and the Commercial Registration

The seizures included many consumer goods and electrical appliances such as connectors, chargers, plugs that are non-conforming to standard specifications, detergents, cosmetics, accessories, hardware, sunglasses, children toys, etc.

Through this intensive inspection campaign covering all regions of the Kingdom, the Ministry aims to control and seize all fake and sub-standard goods, and all products that are not conforming to the approved standard specifications.

The Ministry has announced it will start its inspection and control campaign on outlets of reduced goods, as per their strict plan based on the monitoring and investigation of the sources of counterfeit and fake products. The inspection will be performed through concealed consumers, who will shop for the purpose of collecting information about the sources of fake goods and products, which violate the standard specifications.

MCI field inspection teams, in various regions of the Kingdom, have worked to collect information and do the necessary investigation to seize the products in violation by using the Procedural Guide of Inspectors, which includes the specifications of products and commodities available in the markets.

MCI would like to affirm that it will not hesitate to take stern measures and to impose the legal penalties against any establishment that offers counterfeit or fake goods. The Ministry calls on all consumers to lodge their complaints and observations through the MCI Consumer Call Center "1900" or through the application of a Commercial Violation Report, or via the Ministry’s official website.

For more details, please visit: https://mci.gov.sa/en/MediaCenter/News/Pages/14-04-18-01.aspx


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