July 2019 Regulatory Update

NORTH AMERICA NEWS

US FDA Announces Final Rule on Safety and Effectiveness of Consumer Hand Sanitizers

On April 11, 2019, the US Food and Drug Administration announced a final rule on over-the-counter (OTC) hand sanitizers to ensure they are safe and effective for consumers.

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According to the rule, 28 active ingredients are classified as Category II (not generally recognized as safe and effective or misbranded), which means that available data are insufficient to determine whether the mentioned active ingredients are safe and effective, and further testing is necessary. The ingredients in Category II include:

  • Benzethonium chloride
  • Chloroxylenol
  • Chlorhexidine gluconate
  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
  • Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
  • Methylbenzethonium chloride
  • Nonylphenoxypoly (ethyleneoxy) ethanoliodine
  • Phenol (equal to or less than 1.5% or greater than 1.5%)
  • Poloxamer iodine complex
  • Povidone-iodine 5% to 10%
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triclocarban
  • Triclosan
  • Triple dye
  • Undecoylium chloride iodine complex
  • Polyhexamethylene biguanide
  • Benzalkonium cetyl phosphate
  • Cetylpyridinium chloride
  • Salicylic acid
  • Sodium hypochlorite
  • Tea tree oil
  • Combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine

The three following ingredients are deferred from regulatory action to allow further study and submission of additional safety and effectiveness data when available:

  • Ethyl alcohol
  • Isopropyl alcohol
  • Benzalkonium chloride

Since the majority of OTC hand sanitizers use ethyl alcohol as the active ingredient, it is expected that less than 3% of products will be affected by this final rule.

The Final rule will become effective on April 13, 2020.


US State of Washington Passes Bill to Restrict Toxic Chemicals in Consumer Products

On May 8, 2019, the US State of Washington signed Senate Bill 5135 into law to impose restrictions or prohibitions on chemicals of concern in consumer products.

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With the aim of reducing human exposure to hazardous chemicals from consumer products, the law requires the Department of Ecology (DOE) in consultation with the Department of Health (DOH), to identify priority consumer products that are a significant source of or use priority chemicals, namely:

  • Phthalates
  • Perfluoroalkyl and polyfluoroalkyl substances (PFASs)
  • Organohalogen flame retardants
  • Phenolic compound
  • Polychlorinated biphenyls (PCBs)

The new law enables the DOE to require companies to provide all ingredient information and their potential harm, restrict or prohibit unsafe substances when safer alternatives exist, and identify chemicals that are unsafe to specific demographics or sensitive individuals.

The legislation calls for the DOE to identify its first priority products by June 1, 2020. Regulatory action to address the priority products would need to be determined by June 1, 2022 with rules in place to implement the regulatory actions by 2023. This process is designed to repeat on a five-year cycle starting in 2024, with at least five priority chemicals and related consumer products being identified, reviewed and acted upon.


US State of California Proposes Amendments to Metal-Containing Jewelry Law

On April 24, 2019, the State of California introduced SB 647 to strengthen the California's Metal Containing Jewelry Law.

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If the bill is accepted, the following changes will be made in the current legislation:

  • Revises the definition of “children” to mean persons 15 years of age and younger
  • Adopts federal standard for lead content in children’s jewelry of 100 ppm of lead by weight
  • Establishes Lead and Cadmium limits for surface coatings on children’s jewelry
    Children’s jewelry (15 years and younger):
    Surface coatings [New requirement] Lead ≤ 90 ppm
    Cadmium ≤ 75 ppm
    Accessible components Lead ≤ 100 ppm [New requirement]
    Cadmium ≤ 300 ppm
  • Strengthens the lead content limits in adult jewelry for electroplated metal, unplated metal, and dye or surface coatings to 500 ppm of lead by weight which aligns with ANNEX XVII of the EU REACH regulation
  • Reduces the lead content limit for plastic or rubber to 200 ppm of lead by weight.

The Bill is currently in Committee and will require a majority vote to become a law.


US State of New Jersey Bans Asbestos-Containing Products

On May 10, 2019, the US State of New Jersey passed the A4416 bill into law to prohibit the sale or distribution of asbestos-containing products.

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According to the Title 34 Labor and Workmen’s Compensation, Chapter 5A-34 policy, asbestos is defined as asbestiform varieties of actinolite, amosite (cummuningtonitegrunerite), anthophyllite, chrysotile (serpentine), crocidolite (riebeckite) and tremolite.

Starting from September 1, 2019, any products that contain more than 1% asbestos by weight will be prohibited to be sold, offered for sale or distributed in the State of New Jersey.


US State of Minnesota Revises Their Chemicals of High Concern List

On June 10, 2019, the Minnesota Department of Health (DOH) announced plans to update its Chemicals of High Concern list under the state's Toxic Free Kids Act.

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Starting from 2009, the Act requires the DOH to create both the Chemicals of High Concern list and a Priority Chemicals list of hazardous chemicals that can be found in children's products.

The last update of the Chemicals of High Concern list was conducted in 2016 and a total of 1,769 chemical substances were listed including:

  • Bisphenol A (BPA);
  • Butyl benzyl phthalate (BBP);
  • Dibutyl phthalate (DBP);
  • Di(2-ethylhexyl) phthalate (DEHP);
  • Decabromodiphenyl ether (decaBDE);
  • Hexabromocyclododecane (HBCD);
  • Lead;
  • Cadmium; and
  • Formaldehyde.

A new Chemicals of High Concern list will be published on July 1, 2019 and it will be available on the Department’s website.


US State of Vermont Passes Bill to Amend Reporting Requirements for Chemicals in Children's Products

On June 19, 2019, the Governor of State of Vermont signed Senate Bill 55 into law to introduce new reporting requirements for Chemicals of High Concern (CHCC) in children's products. The law will become effective on July 1, 2019.

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Starting July 1, 2020, manufacturers of children's products containing chemicals on the List of Chemicals of High Concern to Children (CHCC) are required to disclose and report the listed substances to the Department of Health (DOH) once a year instead of the previous biennial reporting requirement. The manufactures shall provide reports to the DOH including brand name, the product model, and the universal product code if available.

In addition, the law authorizes the Commissioner of Health to add new substances to the CHCC list on the basis of credible scientific evidence. The Commissioner may also adopt a rule to regulate the sale or distribution of a children’s product containing a chemical of high concern or require labeling of products which are determined to possibly pose adverse health impacts to children through exposure to CHCC chemicals in the products.


Canada Approves Corded Window Coverings Regulations

On April 15, 2019, Health Canada approved the Corded Window Coverings (CWCs) Regulations SOR/2019-97, which will come into force on May 1, 2021.

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The new regulations repeal the current Corded Window Covering Products Regulations (CWCPR) SOR/2016-172 and introduce the following significant changes:

  • Physical requirements:
    Corded window coverings must comply with the requirements for small parts and cord length. The main requirements are as follows:
    1. Small parts: Every part of a corded window covering that is accessible to a child and can fit inside a small parts cylinder shall not become detached when it is subjected to a force of 90 N applied in any direction.
    2. Unreachable cords: A cord that is not reachable shall remain so, whether the corded window covering is fully opened, fully closed or in any position in between, throughout the useful life of the corded window covering.
    3. Reachable cord with one free end: A reachable cord with one free end shall not exceed 22 cm in length when it is pulled in any direction by the gradual application of a force attaining 35 N.
    4. Reachable cord between two consecutive contact points: A reachable cord with no free end shall not exceed 22 cm in length between two consecutive contact points when it is pulled in any direction by the gradual application of a force attaining 35 N.
    5. Loop created by a reachable cord: If a reachable cord is pulled in any direction by the gradual application of force attaining 35 N, the perimeter of any loop, whether it is existing, created or enlarged, shall not exceed 44 cm.
    6. Two reachable cords: If two reachable cords with one free end each can be connected to one another end to end after each has been pulled in any direction by the gradual application of force attaining 35 N, the length of the resulting cord shall not exceed 22 cm and the perimeter of the loop that is created shall not exceed 44 cm.
  • Chemical requirements:
    External components of a corded window covering must not contain more than 90 mg/kg of lead.
  • Labelling requirements:
    Corded window coverings must carry general information; instructions for assembly, installation and operation; and warnings. Information shall be written in both English and French and either printed on the corded window covering itself or on a label that is permanently affixed to it.

Canada Proposes to Update the Hotlist of Cosmetic Ingredients

In May 2019, Health Canada issued a notice seeking public comment on proposed changes to the Cosmetic Ingredient Hotlist, including several changes to the existing list and new substances to be added.

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Significant proposed changes to the Cosmetic Ingredient Hotlist are as follows:

  • Moving Dihydrocoumarin (CAS 119-84-6) from the prohibited substance list to the restricted list and allowing up to a maximum of 0.035% in a leave-on product and up to 3.5% in a rinse-off product
  • Combining Disulfiram, Thiuram, Thiuram disulfides, and Thiuram monosulfides into a single entry of Thiurams (CAS 97-77-8; 137-26-8) with a maximum use of 14% in latex products.
  • Requiring warning statements for products containing Eucalyptus oil (CAS 8000-48-4)
  • Revising the restriction of Sodium bromate (CAS 7789-38-0) to a prohibition for all Bromates
  • Revising the Hotlist Conditions for Thioglycolic acid (CAS 68-11-1) and its salts

The notice is now under public comment period until July 1, 2019.


EUROPE NEWS

EU Commission Announces Market Surveillance Activities for Food Contact Materials

On May 17, 2019 ,the European Commission published Commission Recommendation (EU) 2019/794 related to the establishment of market surveillance activities for food contact materials in the European Union market.

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According to the incident report and information available in the Rapid Alert System for Food and Feed (RASFF), the following surveillance strategy will be developed to evaluate compliance with food contact requirements as described in Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011 for plastic materials and other applicable legal documents.

Substances to be tested Food contact material to be sampled
Primary aromatic amines (PAA) Plastic tableware and kitchenware and printed food contact materials including paper and board.
Formaldehyde and Melamine Plastic tableware and kitchenware including non-conventional plastic kitchenware and tableware, such as reusable coffee cups using additives in the plastic derived from natural sources such as bamboo.
Phenol Plastic kitchenware and tableware, varnished or coated materials and, printed plastic and paper and board packaging materials.
Bisphenols including BPA and BPS Polycarbonate plastic (BPA) and polyethersulfone plastic (BPS); coated metal packaging (e.g. cans, lids).
Phthalates and non-phthalate plasticisers Plastic materials and articles, in particular those manufactured using polyvinylchloride (PVC) such as thermoformed sheets, flexible packaging and tubing; closures and lids.
Fluorinated compounds Paper and board based materials and articles, including those used to wrap fast-food, take out and bakery products and microwave popcorn bags.
Metals Ceramic, enamel, vitreous and metal kitchenware and tableware including artisanal and traditionally produced materials and articles.
Overall migration Non-conventional plastic kitchenware and tableware, such as reusable coffee cups using additives in the plastic derived from natural sources such as bamboo.

A minimum of 1,650 samples will be collected by the participating member states. The collection should take place from June 1 to December 31, 2019 with results expected to be reported to the Commission by February 29, 2020.


EU Safety Recall Alert – Nickel

In Europe, when hazards are identified in consumer products, the products will be recalled and published in the Rapid Alert System. An increasing number of product recalls related to excessive amount of nickel have been identified.

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A number of products apart from jewelry, with direct skin contact are found in product recalls due to excessive amount of nickel content in the product. Examples of relevant European recalls recorded since 2018 are as follows:

Alert Number Category Product Hazard Image
A12/1542/18 Toys Key ring Excessive amount of Nickel (measured value up to 3.55 µg/cm²/week) is identified from the product
A12/1493/18 Clothing, textiles and fashion items Leather handbag Excessive amount of Nickel (measured value up to 51 µg/cm²/week) released from the clasp of the bag is identified
A12/0907/18 Hobby/sports equipment Whistle Excessive amount of Nickel (measured value up to 1.47 mg/cm²/week) released by metal is identified
A12/0817/18 Toys Paint brush Excessive amount of nickel (measured value up to 4.8 mg/cm²/week) released by the metal part of the paint brush is identified
A12/0614/18 Clothing, textiles and fashion items Mask Excessive amount of nickel (measured value up to 5.27 µg/cm²/week) released from the rivets connecting the rubber band to the mask is identified
A12/0313/18 Toys Keychain Excessive amount of nickel (measured value: 6.15 µg/cm²/week) released by the metallic part of the key ring is identified

Europe Recalls Summary (January 2019 – April 2019)

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 January through April 2019 are summarized below:

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Hazards Frequency
Chemical Hazard 185
Choking Hazard 115
Injury Hazard 83
Electric shock Hazard 81
Fire Hazard 66
Environmental Hazard 60
Other Hazards* 105
*Other Hazards include Asphyxiation Hazard, Burn Hazard, Entrapment Hazard, Hearing Hazard, Microbial Hazard, Sight Hazard, Strangulation Hazard, Suffocation Hazard and Unencrypted Communications with a frequency of less
Product Categories Frequency
Toys and Childcare Articles 254
Cosmetics/ Bodycare 58
Computer / Audio / Video / Other Electronics & Accessories 54
Sporting Goods / Equipment 53
Fabric / Textile / Garment / Home Textile 46
Lighting Equipment 38
Other Categories^ 73
^Other Categories include Candles & Burning Items and Accessories, Consumer Chemicals, Decorative Articles, Eyewear, Food Contact Material, Footwear, Furniture, Home Electrical Appliances (Hair Dryer, Iron, etc.), Homeware (Non-food Contact), Jewelry, Watch or other Fashion Accessories, Personal Protective Equipment (excluding eye protection) and Tools with a frequency of less than 15.

For a complete list click here


ASIA NEWS

China Proposes A New National Standard for Adhesives Used in Food Contact Materials

On May 22, 2019, the China National Centre for Food Safety Risk Assessment (CFSA) announced a public consultation on a draft national standard for adhesives used in food contact materials (FCMs) in China.

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Key information of the draft standard is summarized below:

  • Lists of base polymers that are allowed in the production of food contact adhesives
  • Sensory requirement of food contact adhesive products
  • Migration requirement on any FCMs using an adhesive
  • Overall migration limit of 10 mg/dm2 is set as a general safety requirement within the standard
  • Microbial requirement of food contact adhesive products
  • Design and manufacture of joints and edges of FCMs should be strictly controlled
  • Labeling requirements are stated for the food contact adhesive

The public comment period on the draft standard ends on July 20, 2019.


AUSTRALIA NEWS

Australia Recalls Summary (January 2, 2019 ­– May 27, 2019)

In Australia, when hazards are identified in consumer products, they will be recalled and published in the Recalls and Safety Alerts Database on the Australian Competition & Consumer Commission website, which is updated daily. The Australia recalls from January 2, 2019 to May 27, 2019 are summarized below:

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Hazards Frequency
Injury Hazard 31
Microbial Hazard 14
Choking Hazard 13
Fire Hazard 11
Allergic Hazard 10
Other Hazards* 45
*Other Hazards include Burn Hazard, Drowning Hazard, Electric Shock Hazard, Fall Hazard, Entrapment Hazard, Strangulation Hazard, Suffocation Hazard, Ingestion Hazard with a frequency of less than 10.
Product Categories Frequency
Food 33
Toys and Childcare Articles 29
Tools and Hardware 15
Computer / Audio / Video / Other Electronics & Accessories 11
Home Electrical Appliances (Hair Dryer, Iron, etc.) 8
Other Categories^ 28
^Other Categories include Fabric / Textile / Garment / Home Textile, Consumer Chemicals, Sporting Goods / Equipment, Heater, Furniture, Food Contact Material, Candles & Burning Items and Accessories, Homeware (Non-food Contact), Cosmetics / Bodycare and Eyewear with a frequency of less than 8.

For a complete list click here


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