July 2017 Regulatory Update

NORTH AMERICA NEWS

US State of California OEHHA Issues Notice Regarding Listing Intention for Certain Chemicals

On June 30, 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) issued notice of intent to add the following chemicals to the Proposition 65 list of chemicals known to the state to cause cancer.

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The chemicals are:

  1. N, N-Dimethylformamide [CAS No. 68-12-2]
  2. 2‑Mercaptobenzothiazole [CAS No. 149-30-4]
  3. Tetrabromobisphenol A [CAS No. 79-94-7]

OEHHA is now requesting comments as to whether the above chemicals meet the Proposition 65 criteria for chemcials known to the state to cause cancer. The comment period will end on July 31, 2017.


US State of California OEHHA Approves NSRL for Styrene

On May 11, 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) issued notice to approve No Significant Risk Level (NSRL) for styrene, which was listed in 2016 under Proposition 65 as being known to the state to cause cancer (See Regulatory Recap: May 2016).

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The chemical details and issued NSRL are provided below:

Chemical Chemical Abstracts Service
Number (CAS No.)
Number (CAS No.) No significant risk
level (NSRL)
Styrene 100-42-5 Cancer 27 µg/day

The NSRL is effective July 1, 2017.


US State of California Issues Latest List (May 2017) of Proposition 65 NSRLs and MADLs

On May 17, 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) issued an updated list (May 2017) summarizing the latest No Significant Risk Levels (NSRLs) for carcinogens and Maximum Allowable Dose Levels (MADLs) for reproductive toxic chemicals. The NSRLs and MADLs provide safe harbor limits for Proposition 65 chemicals.

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For Proposition 65 chemicals, if the exposure levels and discharges to drinking water sources are below the safe harbor levels (NSRLs and MADLs), the labeling requirement of Proposition 65 will be exempted. In some cases, enforcement actions may have resulted in negotiated exposure levels relative to specific settlement agreements.


US State of California OEHHA Approved to List Glyphosate under Proposition 65

On June 26, 2017, the California Office of Environment Health Hazard Assessment (OEHHA) issued notice for approving glyphosate being added to the Proposition 65 list (see Regulatory Recap: April 2017).

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The chemical details are provided below:

Chemical Chemical Abstracts Service Number (CAS No.) Types of Toxicity
Glyphosate 1071-83-6 Cancer

Glyphosate is listed under Proposition 65 effective July 7, 2017.


US State of Washington Implements CSPA Phase 1 Restriction Concerning Flame Retardant Chemicals

On July 1, 2017, the Washington House Bill HB 2545 to amend the Children’s Safe Product Act (CSPA) Chapter 70.240 RCW was implemented. The amendment adds restrictions on flame retardant chemicals in children's products and residential upholstered furniture (See Regulatory Recap: April 2016).

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Starting July 1, 2017, manufacturers, wholesalers and retailers shall not manufacture, sell or distribute children’s products and upholstered furniture containing the following flame retardants:

Flame Retardants Chemical Abstracts Service (CAS) Number
Tris(1,3-dichloro-2-propyl)phosphate (TDCPP) 13674-87-8
Tris(2-chloroethyl) phosphate (TCEP) 115-96-8
Decabromodiphenyl ether 1163-19-5
Hexabromocyclododecane (HBCD) 25637-99-4
Tetrabromobisphenol A (Additive TBBPA) 79-94-7

Health Canada Updates Policy Regarding Introducing Infant Sleepwear Size Requirements

In May 2017, Health Canada revised the policy regarding size requirements for infant sleepwear. These requirements are found in Children’s Sleepwear: Flammability Requirement Guidelines (2016) which is regulated under SOR/2016-169 Children Sleepwear Regulations.

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Currently, the guidelines specify that sleepwear designed for infants up to 7 kg with a chest circumference greater than 508 mm, will be subject to the “loose-fitting sleepwear” requirements. The updates to the guidelines will incorporate the following requirements to sleepwear for infants weighing up to 7 kg:

  1. Chest circumference must be less than or equal to 508 mm
  2. Labeling information must bear the intended age grade expressed in months and the age grade must be 9 months or younger

In addition, the updates aim to harmonize the sleepwear size requirements with the U.S. requirements found in 16 CFR 1615. The revised requirements will be incorporated into a new version of the Children’s Sleepwear guidelines, yet to be published.


EUROPE NEWS

REACH – Candidate List Expanded to Include New SVHC

On July 7, 2017, the European Chemicals Agency (ECHA) added 1 new substance of very high concern (SVHC) to the SVHC Candidate List under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The added chemical can be very persistent and very bioaccumulative (vPvB) properties. This addition brings the SVHC Candidate List total to 174 substances.

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The chemical added is:

  1. Perfluorohexane-1-sulphonic acid and its salts

The deadline for notification about the presence of the new SVHCs in articles is January 7, 2018, six months after their inclusion on the List.


ECHA Intends to Propose 5 Chemicals as SVHC

On June 14, 2017, the European Chemicals Agency (ECHA) intended to propose 5 chemicals to be added to the Substances of Very High Concern (SVHC) Candidate List under Regulation (EC) No. 1907/2006 (REACH).

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The proposed chemicals are as follows:

>
Chemicals Chemical
Abstract Service
(CAS) Number
Reason for intension
4,4'-isopropylidenediphenol (BPA) 80-05-7 Serious effects to the
environment
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione,
formaldehyde and 4-heptylphenol, branched and linear
(RP-HP)
- Endocrine disrupting
properties
Cadmium carbonate 513-78-0 Carcinogenic, mutagenic
and toxic for
reproduction.
May cause damage to
organs through
prolonged or repeated
exposure.
Cadmium hydroxide 21041-95-2
Cadmium nitrate 10325-94-7
1,6,7,8,9,14,15,16,17,17,18,18-
dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-
7,15-diene (Dechlorane Plus) [covering any of its individual
isomers or any combination thereof]
- Very persistent and very
bioaccumulative (vPvB)
Tricobalt tetraoxide 1308-06-1 Carcinogenic, mutagenic
and toxic for
reproduction

The expected submission date for the intention is August 7, 2017.


ECHA Approves Amendment of Annex XVII List of Restriction Introducing PFOA

On June 13, 2017, Commission Regulation (EU) 2017/1000 was published to add Perfluorooctanoic Acid (PFOA) to Annex XVII List of Restriction under Regulation (EC) No. 1907/2006 (REACH). The effective date of the regulation was July 4, 2017.

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In the regulation, usage of PFOA and related substances are restricted and several enforcement dates have been appointed to different parts of the regulation (See Regulatory Recap: November 2016).

The first implementation date for the restriction will be July 4, 2020 and applies to the following:

  • - PFOA and related substances shall not be manufactured, or placed on the market as substances on their own.
  • - PFOA and related substances shall not be used in the production of, or placed on the market in a) another substance, as a constituent; b) a mixture, and c) an article, in a concentration equal to or above 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances.

Three other parts of the regulation will be enforced on different enforcement dates respectively, with the second one on July 4, 2022, and the last one on July 4, 2032.


There are several exemptions to this regulation, including:

  • - Perfluorooctane sulfonic acid and its derivatives;
  • - The manufacture of a substance where this occurs as an unavoidable by-product;
  • - A substance that is to be used as a transported isolated intermediate, and
  • - Others

Please refer to the regulation for other exemptions.


ECHA Approved Addition of Chemicals to REACH List of Authorized Chemicals

On June 13, 2017, the European Chemical Agency (ECHA) approved the addition of 12 chemicals to Annex XIV List of Authorization under Regulation (EC) No. 1907/2006 (REACH).

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The chemical details are as follows (Also see Regulatory Recap: October 2016):

Chemicals Chemical Abstract
Service (CAS)
Number
Latest
application date
Enforcement
(sunset) date
1-Bromopropane 106-94-5 4th January, 2019 4th July, 2020
Diisopentylphthalate 605-50-5
1,2-Benzenedicarboxylic acid, di-C6-8-
branched alkyl ester, C7 rich
71888-89-6
1,2-Benzenedicarboxylic acid,di-C7-11-
branhed and linear alkyl ester
68515-42-4
1,2-Benzenedicarboxylic acid,
dipentylester, branched and linear
84777-06-0
Bis(2-methoxyethyl) phthalate 117-82-8
Dipentyl phthalate 131-18-0
N-pentyl-isopentylphthalate 776297-69-6
Anthracene oil 90640-80-5 4th April, 2019 4th October, 2020
Pitch, coal tar, high temp 65996-93-2
4-(1,1,3,3-Tetramethylbutyl)phenol,
ethoxylated (covering well-defined
substances and UVCB substances,
polymers and homologues)
--- 4th July, 2019 4th January, 2021
4-nonylphenol, branched and linear,
ethoxylated
(substances with a linear and/or
branched alkyl chain with a carbon
number of 9 covalently bound in position
4 to phenol, ethoxylated covering UVCB-
and well-defined substances, polymers
and homologues, which include any of
the individual isomers and/or
combination thereof)
---

AUSTRALIA NEWS

Australia Recalls Summary (January to June 2017)

In Australia, when hazards are identified in consumer products, the products will be recalled and published in the Product Safety Australia, which is updated daily. The Australia recalls from January to June 2017 are summarized below:

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Hazards Frequency
Choking Hazard 30
Injury Hazard 30
Allergic Hazard 14
Electric Shock Hazard 12
Burn Hazard 11
Other Hazards* 56
* Other Hazards include Functionality Failure, Chemical Hazard, Drowning Hazard, Entrapment Hazard, Explosion Hazard, Fall Hazard, Fire Hazard, Ingestion Hazard, Insufficient warning label, Laceration Hazard, Scald Hazard, Sight Hazard, Suffocation Hazard, Violation of Mandatory Standard and Violation of Pedal Bicycles Safety Standard with a frequency of less than 10.
Product Categories Frequency
Toys and Childcare Articles 43
Sporting Goods / Equipment 15
Cosmetics / Bodycare 13
Computer / Audio / Video / Other
Electronics & Accessories
10
Other Categories^ 36
^ Other Categories include Fabric / Textile / Garment / Home Textile, Food Contact Material, Furniture, Home Electrical Appliances (Hair Dryer, Iron, etc.), Lighting Equipment, Jewelry, Watch or other Fashion Accessories, Candles & Burning Items and Accessories, Tools, Homeware (Non-food Contact), Juvenile Products with a frequency of less than 10.

Download the complete Recall Cases Summary – AUS (Last Update Date: June 30, 2017)


ASIA NEWS

Singapore Implements RoHS Regulation for EEE Products

On July 1, 2017, the Minister of Environment and Water Resources in Singapore implemented RoHS regulation for controlled electrical and electronic equipment (EEE) that was approved in June 2016 (See Regulatory Recap: September 2016).

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Compared to EU RoHS, Singapore RoHS applies to a narrower group of EEE products that are designed for household use. The restricted chemical limits set forth in the amendment act are summarized below:

  • - Cadmium and its compounds (0.01%)
  • - Hexavalent chromium (0.1%)
  • - Lead and its compounds (0.1%)
  • - Mercury and its compounds (0.1%)
  • - Polybrominated biphenyls (0.1%)
  • - Polybrominated diphenyl ethers (0.1%)

Taiwan Implements New Food Contact Materials Labeling Requirements

On April 18, 2016, the Taiwan Ministry of Health and Welfare issued Notice 1041304938 to establish labeling requirements for food utensils, food containers and packaging in addition to Article 26 (8) of the Food Safety and Health Administration Law. The additional requirements were enacted on July 1, 2017.

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The additional requirements established are summarized below:

  1. Food utensils, containers or packaging shall bear “For food contact use” or equivalent
  2. Food utensils, containers or packaging containing plastic that are intended to come into contact with food shall bear “For repetitive use” or “For single use”, or equivalent
  3. Food utensils, containers or packaging containing polyvinyl chloride (PVC) or polyvinylidene dichloride (PVDC) plastic intended to come into contact with food shall bear “Avoid direct contacting with food with a high fat content at a high temperature” or equivalent
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