10/12/2015 1 Chemicals Quarterly Q2 2015 Presented by Stacey Bowers, MILS 13 August 2015 1 Westchester County law • Westchester County Executive signed the Children’s Product Safety Act into law • Act prevents the sale of infant and children’s products that include harmful toxic chemicals such as formaldehyde, benzene, lead, mercury, antimony, arsenic, cadmium and cobalt within the County of Westchester 2
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10/12/2015
1
Chemicals Quarterly
Q2 2015
Presented by Stacey Bowers, MILS
13 August 2015
1
Westchester County law
• Westchester County Executive signed the Children’s Product Safety
Act into law
• Act prevents the sale of infant and children’s products that include
harmful toxic chemicals such as formaldehyde, benzene, lead,
mercury, antimony, arsenic, cadmium and cobalt within the County
of Westchester
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Lawsuit against Albany County
• AAFA joined the Safe to Play Coalition in a lawsuit against Albany
County
• Recently enacted a new law that prohibits the sale of children’s
cadmium, and cobalt within the County, at any level
• Coalition believes a successful outcome of the lawsuit would result
in a ruling that Local Law 1 violates the Supremacy Clause of the
U.S. Constitution, is preempted by the Federal Hazard Substances
Act (FHSA) and the Consumer Product Safety Act (CPSA), and is,
therefore, void
3
Suffolk County toy law
• Suffolk County Executive signed “Toxin Free Toys Act“
• Per the Resolution, Effective July 1, 2016, no retailer shall:
– Knowingly distribute, sell or offer for sale in the County of Suffolk a children’s product containing mercury, antimony, arsenic or cobalt above 40 PPM of total content per chemical
– Knowingly distribute, sell or offer for sale in the County of Suffolk a children’s product containing lead above 100 PPM of total lead content in accessible parts or above 90 PPM in paint or any similar surface coating.
– Knowingly distribute, sell or offer for sale in the County of Suffolk a children’s product containing cadmium above 75 PPM of total cadmium content.
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Putnam County proposal
• Putnam County, NY, Legislature is considering a proposal to prohibit
toxic chemicals in toys and children's products
• Bill text is not available; however, the Legislature discussed the
Westchester County, NY, law at their June 9 meeting
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New York City bill
• New York City Council is considering a bill, A Local Law to amend
the administrative code of the city of New York, in relation to the sale
of children's products containing certain chemicals
• Bill would prohibit sale and distribution of children’s products
containing the chemicals formaldehyde, benzene, lead, mercury,
antimony, arsenic, cadmium or cobalt in the City
• "Children's product" means a product primarily intended for, made
for or marketed for use by children
• "Child" means an individual aged 12 and under
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New York bill on pet products
• New York's Senate is considering, An act to amend the
environmental conservation law, in relation to regulation of toxic
chemicals in pet products
• Bill would restrict "priority chemicals" in pet products
• Defines "priority chemicals" to mean:
– Arsenic and compounds, including arsenic trioxide and dimethyl arsenic
– Benzene
– Cadmium
– Cobalt and compounds
– Lead and compounds (inorganic)
– Mercury and compounds, including methyl mercury
– Molybdenum and compounds
– Tris (1,3 dichloro-2-propyl) phosphate
7
New ISO toy standard
• International Organization for Standardization (ISO) issued a new
standard, ISO 8124-5:2015, Safety of toys -- Part 5: Determination
of total concentration of certain elements in toys
• Specifies methods of sampling and digestion prior to analysis of the
total concentration of the elements antimony, arsenic, barium,
cadmium, chromium, lead, mercury, and selenium from toy materials
and from parts of toys
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China RoHS 2 draft
• China's Ministry of Industry and Information Technology (MIIT) has
released a new draft of China RoHS
• There is no list of covered products in the revised draft
• Substance restrictions remain limited to 6 substances (lead,
mercury, cadmium, hexavalent chromium, PBB and PBDE)
• Product labels must include the environmental protection use period
(EFUP) and information on hazardous substance content
9
Singapore clarifies RoHS proposal
• Singapore’s National Environment Agency (NEA) has responded to
comments on its proposed RoHS measure
• The response shows that Singapore’s proposed RoHS will be in
close alignment with EU RoHS
– Like the EU, Singapore intends to exclude batteries from scope in the first instance
– It also intends to adopt the full list of RoHS exemptions and update it regularly to reflect changes in the EU’s exemptions list
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EU Regulation on lead in jewelry
• The Regulation establishes restrictions on lead in jewelry, as
follows:
– Shall not be placed on the market or used in articles supplied to the general public, if the concentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or greater than 0.05 % by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children.
• Limit shall not apply where:
– Rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0.05 µg/cm2 per hour (equivalent to 0.05 µg/g/h),
– For coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article
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Massachusetts jewelry bill
• Massachusetts House is considering H.253, An Act Relative to the
Sale of Children's Jewelry
• “Children's jewelry," is jewelry designed or intended primarily for
use by children 12 years of age or younger to be worn as an item of
personal ornamentation
• Per the bill, all children’s jewelry sold shall meet the requirements of
ASTM F 2923-14
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New York State jewelry bill
• New York's Assembly is considering
A6672, An act to amend the public
health law, in relation to the sale of
children's jewelry containing cadmium
• Bill would establish a limit of .5 parts
per million cadmium
13
Rhode Island formaldehyde bill
• Rhode Island's General Assembly has introduced House Bill 5691,
An Act Relating to Health and Safety - Formaldehyde Control
• Per the bill, no manufacturer or wholesaler may sell or offer for sale
in this state a children's product that intentionally contains:
– Formaldehyde, including formaldehyde contained in a solution; or
– Intentionally added chemical ingredients that chemically degrade under normal conditions of temperature and pressure to release free formaldehyde at levels exceeding a de minimus level of five one-hundredths of one percent (0.05%)
• Defines "child" to mean a person under eighteen (18) years of age
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US EPA's projected publication date extended for
Formaldehyde Standards
• US EPA's projected publication date extended for Formaldehyde
Standards and Third-Party Certification Framework
• In 2013, EPA issued a proposed rule under TSCA to establish a
framework for a Third-Party Certification Program whereby third-
party certifiers are accredited by accreditation bodies so that they
may certify composite wood product panel producers under TSCA
title VI
• EPA is developing a final rule to establish specific formaldehyde
emission limits for hardwood plywood, particleboard, and medium-
density fiberboard, which are identical to the California emission
limits for these products
• EPA may issue a single final rule to promulgate the final
requirements related to both proposed rules
15
Phthalates added to EU ROHS
• Commission Delegated Directive (EU) 2015/863 of 31 March 2015
added four phthalates to the EU ROHS Directive
• The four phthalates are DEHP, BBP, DBP and DIBP
• Ten hazardous substances will now be restricted in Electric and
Electronic Equipment (EEE) under the EU RoHS Directive
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Maine designates priority chemicals
• Maine has posted its final Chapter 888 rule, which took effect June
22, 2015
• Designates four members of the chemical class phthalates as
priority chemicals
• Deadline for reporting is December 19, 2015
• Reporting requirement applies to manufacturers or distributors of
certain children’s products that contain intentionally added di(2-
decabromodiphenyl ether, hexabromocyclododecane, or the additive
form of TBBPA, in amounts greater than one thousand parts per
million in any product component, beginning July 1, 2016
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Minnesota has enacted SF 1215
• On and after July 1, 2018, the act prohibits the manufacture, sale,
offer for sale, distribution for sale, or distribution for use of a
children's product or upholstered residential furniture containing, in
amounts greater than 1,000 ppm in any product component, the
following flame-retardants:
– tris(1,3-dichloro-2-propyl)phosphate (TDCPP)
– decabromodiphenyl ether
– hexabromocyclododecane
– tris(2-chloroethyl)phosphate (TCEP)
• After July 1, 2019, no retailer may sell or offer for sale or use a
children's product or upholstered residential furniture containing in
amounts greater than 1,000 ppm in any product component the
flame retardant chemicals listed above
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Denmark report on textiles and car seats
• Denmark's Environmental Protection Agency issued a report,
Chemical substances in car safety seats and other textile products
for children
• Substances selected for quantitative chemical analysis were
phosphorus-based flame retardants, the phthalate DIDP, azo dyes,
isocyanates and brominated flame retardants
• Substances found in most samples in significant concentrations
were the phosphorus-based flame retardants TCEP, TCPP and
TDCP and two isomers of diisodecyl phthalate (DIDP)
• Illegal level of an aromatic amine, indicating use of azodyes, was
found in one product
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Taiwan formamide limit
• Taiwan's BSMI has notified of an Announcement for Legal
Inspection of Toys Commodities
• On 13 January 2015, the revised version of CNS 4797 was
published
• Main modifications of revised CNS 4797 are:
– changing limitation of Formamide from 2 ppm to 200 ppm;
– the test methods announced by Ministry of Health and Welfare for food microorganisms are adopted as biological safety requirement for toys containing a liquid substance
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Proposed EU toy amendments
• European Union is considering several proposed amendments to the Toy Safety Directive, which would establish restrictions on:
• Benzisothiazolinone: 5 mg/kg (content limit);
• Chloromethylisothiazolinone and methylisothiazolinone:
– Reaction mass of: 5-chloro-2- methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1): 1 mg/kg (content limit);
– 5-Chloro-2-methyl-isothiazolin-3(2H)-one: 0.75 mg/kg (content limit); and
• Formamide: 20 µg/m3 (emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials containing more than 200 mg/kg (content limit); and
• Phenol:
– 5 mg/l (migration limit) in polymeric materials;
– 10 mg/kg (content limit) as a preservative
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Assessment of Methylisothiazolinone in Consumer
Products
• Methylisothiazolinone (MI) is a preservative and is found in a wide
range of consumer products
• There has been an increase in incidence of allergies to MI
• Thirty-one products within the following four product categories:
cosmetics and personal care, detergents and household cleaning
products, paints, varnishes and adhesives and toys and hobby
products were selected for chemical analysis
• Products contained 1.8-135 ppm MI
29
Vermont bill on chemicals of high concern
• Vermont's Senate is considering
S.139, on pharmacy benefit
managers, which also would also
modify the circumstances under
which the Commissioner of
Health may adopt a rule
regulating the sale or distribution
of a children’s product containing
a chemical of high concern to
children
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Oregon bill on high priority chemicals
• Oregon's State Legislature is considering House Bill 3473, The
Toxic-Free Kids Act
• Act would establish and maintain a list of high priority chemicals of
concern for children's health
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Massachusetts children’s products bills
• Massachusetts House H. 697, An Act relative to the disclosure of
toxic chemicals in children’s products
• Bill would establish a list of toxic chemicals in children's consumer
products, to be made available to the public via the Department of
Environmental Protection website
• Massachusetts Senate is considering two bills to restrict toxic
chemicals: S.397, An Act relative to healthy families and businesses,
and S.453, An Act for a competitive economy through safer
alternatives to toxic chemicals
• Bills would require the publication of a “chemicals of concern” list,
followed by designation and assessment of Priority Chemical
Substances
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New York State Senate bill
• S.5995, An Act to amend the environmental conservation law, in
relation to regulation of toxic chemicals in children's products
• Bill would establish list of "Priority Chemicals“
• Bill would require, no later than 12 months after a priority chemical
appears on the list, every manufacturer who offers a children's
product for sale or distribution in the state to report such chemical
use to the DEP, at practical quantification limits (PQLs)
• Bill would prohibit the distribution, sale or offer for sale of a
children's product containing the priority chemicals
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New York State bills stalled
• NY Governor Andrew Cuomo's administration will propose its own
version of A.5162 and S.410, which are “stalled.”
• Administration’s proposal expected to include:
– Department of State would regulate the Act, rather than the Department of Environmental Protection (DEP);
– Act would apply to products including cosmetics, juvenile products, school supplies and toys; and
– State attorney general's office would enforce the Act
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Minnesota children’s products bills
• Minnesota State Legislature has introduced three bills regulating the
labeling and reporting of hazardous chemicals in children’s products:
HF 1553 (and its companion SF 1656) and HF 1276
• Each of the bills would require a manufacturer or distributor of a
children's product offered for sale in this state that contains a priority
chemical must label each unit of that product offered for sale in this
state as follows:
– "WARNING: This product contains [NAME OF PRIORITY CHEMICAL], a chemical known or suspected with a high degree of probability by the Minnesota Department of Health to be potentially hazardous to human health."
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Egyptian toy Decree
• EOS has notified the WTO of Ministerial Decree No. 974/2014 on
the mandatory Egyptian Standard ES 7093/2014 "Essential
Requirements for Safety of Toys."
• The Ministerial Decree mandates that the producers and importers
must comply with ES7093/2014
• Standard complies with 2009/48/EC
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AAFA publishes Restricted Substance List
• On June 15, American Apparel & Footwear Association (AAFA)
released the 16th edition of the Restricted Substance List , a
chemical management resource for banned or restricted chemicals
and substances in finished home textile, apparel, and footwear
products
37
Chinese textile products standards
• China has published two standards on safety of children's apparel:
– GB 31701:2015, Infant and Child Safety Technical Code for Textile Products
– GB/T 31702:2015. Testing method for sharpness of attached components on textile products
• GB 31701:2015 specifies the safety technical requirements, test
methods and inspection rules for infants and children textile
products
• Products like fabric plush toys, fabric handicraft, single-use sanitary
dioxane [2] [covering any of the individual isomers of [1] and [2] or
any combination thereof]
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Commentary on REACH
• Chris Robertson from Edif ERA has added Expert Commentary to
C2P on REACH Enforcement Action and Authorised Uses
• 21 August 2014 marked the sunset date on the use of the first three
Substance of Very High Concern (SVHC) listed in Annex XIV of
REACH
• After the sunset date the placing on the market or use of an Annex
XIV substance in the EU is prohibited unless specific authorisation
has been applied for and granted to the specific user
• By the end of August 2015 the sunset date will has passed for 14 of
these substances so the Forum for Exchange of Information on
Enforcement, which comprises the member state market
surveillance authorities (MSAs), has decided it is time to investigate
how diligent industry is being in complying with their duties
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Commentary on K-REACH Registration &
Reporting
• Expert Commentary from our data partner, Kim, Choi & Lim,
• Factsheets on K-REACH Registration & Reporting
• Ministry of Environment has recently published two English booklets
in relation to the Act on Registration, Evaluation, Etc. of Chemical
Substances
• “Report and Registration of Chemical Substances” includes
information regarding the report, registration, examination and
evaluation of chemical substance, report and registration of
roadmap, and matters related to the reporting system
• “Safety Management System for Household Chemical Product”
includes information regarding the items that are subject to
management under the Act, safety/labeling standards, and matters
related to the reporting system
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Japanese platform for chemical regulatory
information
• Japanese Ministry of Economy, Trade and Industry (METI)
announced the launch of ASEAN-Japan Chemical Safety Database
(AJCSD)
• AJCSD will be a helpful tool for companies establishing chemical
trade with Japan, Cambodia, Indonesia, Laos, Myanmar, Malaysia,
Philippines and Thailand
• The inquiry results consist of the following parts:
– Chemical identifiers
– Regulatory information
– Hazard information
– Hazard assessment reports and sample SDSs to be supplemented
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TSCA Modernization bill
• US House Committee introduced H.R. 2576, The TSCA
Modernization Act, would:
– Create a new system for EPA to evaluate and manage risks associated with chemicals already on the market
– Either EPA or a manufacturer may designate a chemical for risk evaluation
– Provide limited preemption of state law
– Once EPA makes a final decision on a chemical, either a new rule or a determination that it poses no unreasonable risk, EPA action would apply in all states
– Prior state laws that do not conflict with TSCA, and private rights of action under tort or contract law, are preserved
– Maintain protection of confidential business information
63
California ARB seeks data on VOCs
• The California Air Resources Board’s (ARB) 2014 data reporting for
the Consumer Products Program began 1 July 2015 and ends 1
November 2015
– Reporting is mandatory for all Responsible Parties that sold consumer products in California during the 2014 calendar year
• The rationale of these reports is to:
– Provide a scientific foundation for further VOC emission reductions
– Update the consumer products emissions inventory
– Evaluate the use of low vapor pressure VOC emissions (LVP-VOCs)
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Proposed Prop 65 Web site regulation modified
• California Environmental Protection Agency’s Office of
Environmental Health Hazard Assessment (OEHHA) modified the
text of the proposed regulation
• Changes were made to:
– OEHHA’s disclaimer on the website
– Limit the scope of the information OEHHA may request
– testing is not required for the sole purpose of providing information in response to a request for information under this section.
– fifteen (15) day notice period required for notification of a business under section (d) has been extended to thirty (30)
– “Confidential Business Information” has been replaced with the term “trade secret”
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Prop 65 intent to list chemicals
• California Environmental Protection Agency’s Office of
Environmental Health Hazard Assessment has published several
notices of intent to list chemicals
• Chemicals that cause cancer
– Aloe vera, whole leave extract
– Goldenseal root powder
– Teriparatide
– CMNP (Pyrazachlor)
– Sedaxane
• Reproductive toxicity
– ethylene glycol (ingested)
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Publication of new data on nanomaterials
• The Organisation for Economic Co-operation and Development’s (OECD) Working Party on Manufactured Nanomaterials has started the publication of new data on 11 nanomaterials in IUCLID format:
– Fullerenes;
– Single-walled carbon nanotubes;
– Multi-walled carbon nanotubes;
– Silver;
– Gold;
– Dendrimers;
– Silicon dioxide (six different forms);
– Nanoclays;
– Titanium dioxide (six different forms);
– Cerium dioxide; and
– Zinc oxide.
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