March 2020 Regulatory Update

NORTH AMERICA NEWS

EPA Announces New Chemicals to Undergo Risk Evaluation under TSCA

On December 20 2019, the U.S. Environmental Protection Agency (EPA) announced the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).

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It is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk. These chemicals will move through the process required by TSCA to evaluate any unreasonable risks they may present to human health or the environment.

The new 20 chemicals to be listed as high-priority chemicals are as follows:

  • p-Dichlorobenzene (CAS: 106-46-7)
  • 1,2-Dichloroethane (CAS: 107-06-2)
  • trans-1,2- Dichloroethylene (CAS: 156-60-5)
  • o-Dichlorobenzene (CAS: 95-50-1)
  • 1,1,2-Trichloroethane (CAS: 79-00-5)
  • 1,2-Dichloropropane (CAS: 78-87-5)
  • 1,1-Dichloroethane (CAS: 75-34-3)
  • Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester) (CAS: 84-74-2)
  • Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (CAS: 85-68-7)
  • Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester) (CAS: 117-81-7)
  • Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (CAS: 84-69-5)
  • Dicyclohexyl phthalate (CAS: 84-61-7)
  • 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CAS: 79-94-7)
  • Tris(2-chloroethyl) phosphate (TCEP) (CAS: 115-96-8)
  • Phosphoric acid, triphenyl ester (TPP) (CAS: 115-86-6)
  • Ethylene dibromide (CAS: 106-93-4)
  • 1,3-Butadiene (CAS: 106-99-0)
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) (CAS: 1222-05-5)
  • Formaldehyde (CAS: 50-00-0)
  • Phthalic anhydride (CAS: 85-44-9)

US State of New York Passes Children's Product Chemical Disclosure Law

On February 7, 2020, the Governor of New York State signed bill S.501B and announced new legislation to require manufacturers to disclose the use of chemicals in children's products. The Department of Environmental Conservation (DEC) is required to make this information public to consumers. This act shall take effect on March 1, 2020.

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In the final rule, the key information related to the law is summarized below:

  • Defines children as "a person or persons aged twelve and under."
  • Defines a children's product as "a product primarily intended for, made for or marketed for use by children."
  • Requires the Department of Environmental Conservation (DEC) to post lists of dangerous chemicals and chemicals of concern on the Department's website and review the list periodically with the consultation of the Department of Health.
  • When children's products contain dangerous chemicals or chemicals of concern, manufacturers are required to report to the DEC with the information below:
    1. Identification of the product,
    2. Name of the dangerous chemicals or chemicals of concern, included, and, the
    3. Intended purpose of the chemicals

  • Manufacturers are required to notify persons that offer the children's products for sale or distribution in the state when the product contains dangerous chemicals.
  • The DEC is required to notify consumers about children's products containing chemicals of concern and dangerous chemicals.
  • Starting as of January 1, 2023, the sale of children's products containing certain dangerous chemicals such as benzene, tris (1, 3 dichloro-2-propyl) phosphate, formaldehyde (other than in textiles), organohalogen flame retardants, and asbestos will be prohibited.

OEHHA Proposes a New Amendment to the Proposition 65 Warning Regulations

On January 31, 2020, the Office of Health Hazard Assessment (OEHHA) published a proposed amendment to clarify the exposure warning requirements regarding internet and catalog sales activities.

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The key changes in the proposal are summarized below.

  • Clarified the option of providing warnings via an electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of a product is only applicable at a “physical retail location."
  • Included the sales activity through mobile device applications under the definition of “internet purchases" and corresponding exposure warnings requirements would be applied.
  • Introduced the exposure warnings requirement for alcoholic beverages sold over the internet and in a catalog. The proposal offers a new option of delivering the exposure warning by email or text message.

The new amendment was under a public comment period until March 2, 2020.

  1. Cannabis (marijuana) smoke
  2. Δ9 -Tetrahydrocannabinol (Δ9 -THC)

US State California OEHHA Adds New Chemicals to Proposition 65 Chemical List

On January 3, 2020, the California Office of Environmental Health Hazard Assessment (OEHHA) added 2 new chemicals to the Proposition 65 List. The new chemicals are:

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The added chemicals meet the requirements for Prop 65 listing as known to the State of California to be a developmental hazard. The chemical details are provided below:

Chemical Chemical Abstracts Service Number (CAS No.) Types of Toxicity
Cannabis (marijuana) smoke N/A Developmental Hazard
Δ9 -Tetrahydrocannabinol (Δ9 -THC) N/A Developmental Hazard

California Proposition 65: Recent Settlements and 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 settlements from July through December of 2019 include the following:

Source Chemical Limits
Chests with Vinyl Handles DEHP 1000 ppm
Mugs with an Exterior Design Lead 90 ppm
Glasses DEHP 1000 ppm
Totes, Bags, Purses and Their Associated Straps DEHP 1000 ppm
Plastic Sandals DBP 1000 ppm
Bags / Cases / Totes DEHP 1000 ppm

Recent 60-day notices from July through December of 2019 include the following:

Chemical Product / Source Number of Notices
Acrylamide Backpacks / Bags / Handbags /Wallets / Badge Holders / Pouches / Fanny Packs / Tote bags and Accessories 1
Chemical Products 1
All-trans retinoic acid Chemical Products 1
Arsenic (inorganic arsenic compounds), Arsenic (inorganic oxides), Chromium (hexavalent compounds), Lead, Lead and lead compounds, Silica, crystalline (airborne particles of respirable size) Cosmetics / Body care 6
Bisphenol A (BPA) Cases 1
Face Shields 1
Kitchen Instant Marinator 1
Pasta Drying Racks 1
Percolator Tops 2
Tumblers 1
Carbon monoxide Candles / Burning Items and Accessories 1
Lighters 2
Chromium (hexavalent compounds) Footwear 5
Gloves 14
Personal Protective Equipment 1
Demeclocycline hydrochloride (internal use) Footwear 1
Di(2-ethylhexyl)phthalate (DEHP) Adapters / Electrical Wires / Extension Cords / Flashlights / HDMI Cables / Wire Strippers 9
Armbands / Ankle bands / Hand bands 2
Backpacks / Bags / Handbags /Wallets / Badge Holders / Pouches / Fanny Packs / Tote bags and Accessories 251
Bags & Dresses 1
Bathroom Supplies / Kitchen Supplies 9
Bedding 27
Bells 1
Blades 1
Books 1
Cables 3
Cases / Travel Cases / Packaging 55
Cases / Wallets 1
Chairs & Cases 1
Clothes / Pants / Caps / Hats / Eyewear Pouches / Sleeves / Eye Pillows / Facial Mitts / Masks / Belts / Gloves 15
Clothesline 1
Clutches 1
Computer / Audio / Video / Other Electronics & Accessories 18
Coolers 1
Cosmetics / Body care 12
Covering 3
Electrical Tape 1
Fabric 1
Fireworks 1
Fishing Equipment 2
Flags 1
Food Contact Materials 1
Footwear 7
Furniture 3
Hair Bands / Hair Extensions 1
Hairbrushes 1
Hair Roller sets and Plastic cases 1
Hangers 2
Headwear 1
Holders 2
Homewares 1
Ice Bags 1
Ice Compression Wraps 1
Jewelry / Jewelry Organizer / Keychains 3
Journals 1
Key Rings 1
Kits 7
Lanyards 2
Lift Vests 1
Lighting Equipment 3
Locks / Hooks 3
Log Chains 1
Magnets 1
Mirrors 1
Organizers / Huggers 7
Packs 3
Panels / Tiers / Covering / Bath Curtains / Mats / Nets 30
Pet Supplies 8
Pouches & Cases 1
Protectors 1
Purses 8
Scrapers 1
Shades 1
Shower Caps 1
Sporting Goods / Equipment 17
Stationery / Stickers / Non-slip Stickers / Tags 13
Tapes 2
Threading Sets & Cases 2
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 76
Trays 1
Travel Sets 1
Toys / Childcare Articles 5
Washers 1
Wine Slickers 1
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP) Backpacks / Bags / Handbags /Wallets / Badge Holders / Pouches / Fanny Packs / Tote Bags and Accessories 6
Bedding 1
Cases / Travel Cases 1
Lanyards 1
Shift Knobs 1
Sporting Goods / Equipment 1
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 1
Di(2-ethylhexyl)phthalate (DEHP), Diisononyl phthalate (DINP), Lead Tools 1
Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP) Food Contact Materials 1
Footwear 3
Organizers 1
Sporting Goods / Equipment 1
Di(2-ethylhexyl)phthalate (DEHP), Di-n-butyl phthalate (DBP), Diisononyl phthalate (DINP), Lead Adapters / Electrical Wires / Extension Cords / Flashlights / HDMI Cables / Wires Strippers 1
Di(2-ethylhexyl)phthalate (DEHP), Lead Organizers 1
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings 1
Di(2-ethylhexyl)phthalate (DEHP), Lead, Nickel Clothes / Pants / Caps / Hats / Eyewear Pouches / Sleeves / Eye Pillows / Facial Mitts / Masks / Belts / Gloves 1
Diethanolamine Cosmetics / Bodycare 4
Diisononyl phthalate (DINP) Adapters 2
Backpacks / Bags / Handbags /Wallets / Badge Holders / Pouches / Fanny Packs / Tote bags and Accessories 67
Bathroom Supplies / Kitchen Supplies 2
Battery Testers 1
Bedding 2
Binders 1
Cosmetics / Bodycare 1
Cases 4
Clothes / Pants / Caps / Hats / Eyewear Pouches / Sleeves / Eye Pillows / Facial Mitts / Masks / Belts / Gloves 6
Computer / Audio / Video / Other Electronics & Accessories 4
Cords 1
Docking Station 1
Footwear 1
Furniture 1
Hair Bands / Hair Extensions 1
Hangers 1
Hoses 1
Jewelry / Jewelry Organizer / Keychains 1
Kits 2
Lighting Equipment 1
Panels / Tiers / Coverings / Bath Curtains / Mats / Nets 3
Purses 1
Rain Slickers / Rain Suits 1
Sporting Goods / Equipment 2
Stationery / Stickers / Non-slip Stickers / Tags 2
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 10
Toys / Childcare Articles 3
Watch Bands 1
Di-n-butyl phthalate (DBP) Adapters / Electrical Wires / Extension Cords / Flashlights / HDMI Cables / Wires 2
Backpacks / Bags / Handbags /Wallets / Badge Holders / Pouches / Fanny Packs / Tote bags and Accessories 3
Bathroom Supplies / Kitchen Supplies 2
Footwear 11
Light Hanging Poles 1
Locks 1
Scoop Sets 1
Sporting Goods / Equipment 1
Stationery / Stickers / Non-slip Stickers / Tags 1
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings 5
Formaldehyde (gas) Apparel 1
Lead Adapters / Electrical Wires / Extension Cords / Flashlights / HDMI Cables / Wires 6
Backpacks / Bags / Handbags /Wallets / Badge Holders / Pouches / Fanny Packs / Tote bags and Accessories 4
Bathroom Supplies / Kitchen Supplies 2
Belts 1
Candles/ Burning Items and Accessories 1
Canisters with PVC Seals 2
Ceramic Spoon Rests 1
Fishing Equipment 5
Food Contact Materials 18
Footwear 1
Glassware 2
Hoses 1
Kits 1
Knobs 2
Locks / Hooks 1
Mats 1
Padlocks 1
Scales 1
Splitters 1
Sporting Goods / Equipment 1
Stationery / Stickers / Non-slip Stickers / Tags 1
Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 43
Toys / Childcare Articles 1
Trays 3
Valves 1
Valves & Showers 1
Whistles 1
Lead and lead compounds Tool Pouches / Tool Grips / Brass Tools / Garden Tools / Cutting Tools / Fittings and Valves / Other Tools 3
Polychlorinated biphenyls Bathroom Supplies / Kitchen Supplies 2
Soots, tar and mineral oils (coal tar) Torches 1

EUROPE NEWS

REACH – Candidate List Expanded to Include New SVHCs

On January 16, 2020, the European Chemicals Agency (ECHA) added 4 new substances of very high concern (SVHC) to the SVHC Candidate List under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The added chemicals can be reproductive toxins as well as having persistent, bioaccumulative and toxic (PBT) properties. Their addition brings the total SVHC Candidate List to 205 substances.

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The chemicals added are:

  • Diisohexyl phthalate (CAS: 71850-09-4)
  • 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone (CAS: 119313-12-1)
  • 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (CAS: 71868-10-5)
  • Perfluorobutane sulfonic acid (PFBS) and its salts

Turkey Amends Toy Safety Regulation

On December 24, 2019, Turkey issued Regulation Number 30988 to further align the Turkey Toy Safety Regulation (Oyuncak Güvenliği Yönetmeliği, OGY) with the European Toy Safety Directive 2009/48/EC.

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Key amendments to the current OGY are summarized below.

  • New legal limit of 0.053 mg/kg for Chromium (VI) for material category III has been adopted
  • Updated migration limits for lead in all three categories of toy materials
  • Reduced the migration limit for bisphenol A (BPA) to 0.04 mg/l for toys intended for children under 36 months of age or other toys intended to be placed in the mouth
  • Introduced Phenol content requirement for toys intended for children under 36 months or other toys intended to be placed in the mouth

The above new rules will be effective on December 24, 2020.


Turkey Amends Food Contact Plastic Regulations

On December 25, 2019, Turkey issued Notification No. 2019/43 and Notification No. 2019/44 to align the Turkey food contact plastics requirements with Regulation (EU) 10/2011.

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Notification No. 2019/44

  • Technical equivalence to Commission Regulation (EU) No 10/2011 (except Annex III)
  • General specifications of plastic food contact materials and articles, including overall migration and specific migration limit requirements
  • Repealed Notification No. 2013/34 published in Official Journal No. 28710 dated July 17, 2013

Notification No. 2019/43

  • Technical equivalence to Annex III of Commission Regulation (EU) No 10/2011
  • Defines the food Simulants used in migration tests
  • Repealed Notification No. 2013/35 published in Official Journal No. 28710 dated July 17, 2013

The above new rules will be effective on December 31, 2020.


ASIA NEWS

Taiwan Approves New Certification Requirements for Children’s Cots and Folding Cots

On January 20, 2020, the Bureau of Standards, Metrology and Inspection (BSMI) of Taiwan approved the proposal to introduce new certification requirements for children’s cots and folding cots.

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Children’s cots and folding cots for domestic use with an internal length between 900 mm and 1400 mm shall be subject to the BSMI certification. Carry cots, cribs and cradles are excluded. The products concerned shall be tested according to CNS 11676:2019 Children's cots and folding cots for domestic use, which is based on the ISO counterpart ISO 7175:2019 (Parts 1 and 2).

For conformity assessment, products shall follow either the:

  1. Batch-by-Batch Inspection (Type Approval); or
  2. Registration of Product Certification (RPC) Scheme, which involves:
    • Product type-test by BSMI or BSMI-designated laboratories;
    • Product registration at BSMI; and
    • A Declaration of Conformity issued by the manufacturer or importer

A six month transitional period will be provided once the new requirements enter into force on March 1, 2020. Products are required to comply with the new rule when they are imported or placed on the Taiwan market starting from September 21, 2020.


SASO NEWS

SASO Announces to Extend the Validity of Product Certificate

Due to the global virus conditions, Saudi Arabian Standards Organization (SASO) has extended the validity of product certificates registered in the SABER platform.

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Within its exceptional initiatives and in appreciation of the conditions of the traders and importers, as well as supporting the rapid entry of products into the Saudi market, SASO would like to announce the following initiatives:

  • Extending the validity of all product certificates registered in SABER that will expire in the months of March, April or May 2020 for 3 more months from the expiration date of the certificate.
  • Accepting the test reports that are issued by approved laboratories in the country of export up to 3 years, without the need to arrange new tests.

Thus, traders and importers are able to get the Shipment Certificate via SABER platform for the shipments that will be imported during this period of time based on the previous test reports and product certificates which its period will be extended automatically in SABER platform without the need to apply for renewal of the product certificates or conducting new test reports.


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