chemicals quarterly - q2 2015
TRANSCRIPT
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
products containing benzene, lead, mercury, antimony, arsenic,
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
5
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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5
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
11
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-
ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl
phthalate (BBP), or diethyl phthalate (DEP), that are for sale in
Maine
17
California DINP ruling appeal
• American Chemistry Council (ACC) has appealed a Sacramento
Superior Court ruling that denied its petition to reverse the
Proposition 65 listing of diisonoyl phthalate (DINP) as a chemical
know to the state to cause cancer
• California's Superior Court refused to reverse the Office of
Environmental Health Hazard Assessment's (OEHHA) listing back in
March, and the ACC responded by filing an appeal last month
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10
NGOs petition for prohibition of flame retardant
• NGOs have petitioned the US Consumer Product Safety
Commission (CPSC) for a rulemaking to prohibit organohalogen
flame retardants in children's products, as well as in furniture,
mattresses and electronics
• The chemicals in question include: DecaBDE, DEHP, HBCD,
octaBDE, pentaBDE, PBDE, TCPP, TDCPP, and TDBPP
19
California flame retardant bill
• California has introduced CA SB 763, Juvenile products: flame
retardant chemicals
• Bill would require the disclosure of toxic chemicals in juvenile
products
• "Juvenile product" includes, but is not limited to, a bassinet, booster
seat, car seat, changing pad, floor play mat, highchair, highchair
pad, infant bouncer, infant carrier, infant seat, infant swing, infant
walker, nursing pad, nursing pillow, playpen side pad, portable hook-
on chair, stroller, children's nap mat, baby carrier that is worn by an
adult, foam crib mattress, and children's upholstered furniture
• "Flame retardant chemical" means any chemical or chemical
compound for which a functional use is to resist or inhibit the spread
of fire
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Massachusetts flame retardant bill
• S.1132, An Act to protect children and families from harmful flame
retardants
• Per the bill, no person, other than a retailer, shall manufacture or
knowingly sell, offer for sale, distribute for sale or distribute for use in
the commonwealth, any children’s product or residential upholstered
furniture containing TRIS in amounts greater than 1,000 parts per
million in any product component
• No manufacturer, wholesaler, principal importer or retailer shall
manufacture or knowingly sell, offer for sale, distribute for sale or
distribute for use in the commonwealth any product containing
PBDEs in a concentration greater than .1% by weight
21
Massachusetts hearing on flame retardant bill
• At a public hearing before the Joint Committee on Public Safety and
Homeland Security, Massachusetts firefighters, citizens, scientists,
health professionals, workers, and educators seeking preventive
action on toxic hazards called for swift passage of a bill that would
help to protect firefighters and children from toxic flame retardants
• H. 2119, The Children and Firefighters Protection Act would ban the
use of hazardous flame retardants in children’s products and
upholstered furniture
• The flame retardant chemicals that would be phased out include
Chlorinated Tris (TDCPP, TCEP, TBBPA), Decabromodiphenyl ether,
Antimony trioxide, HBCD, TBPH, TBB, Chlorinated paraffins, and
TCPP
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New York State flame retardant bills
• The New York State is considering three bills to restrict flame
retardants in upholstered furniture:
– Assembly Bill 7837
– Senate Bill 2745 and
– Senate Bill 3844
• Bills would restrict any halogenated flame retardant, including
TDCPP and any phosphorous-bromine flame retardant
23
Washington State bill
• SB 6131, An act relating to requiring safer chemicals in Washington
• Bill would prohibit any manufacturer, wholesaler, or retailer from
manufacturing, knowingly selling, offering for sale, distributing for
sale, or distributing for use children's products or residential
upholstered furniture containing TDCPP (tris(1,3-dichloro-2-
propyl)phosphate), TCEP (tris(2-chloroethyl)phosphate),
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
25
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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14
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
27
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
– 2-methylisothiazolin-3(2H)-one: 0.25 mg/kg (content limit);
• 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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16
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
31
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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17
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
33
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
34
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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."
35
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
36
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19
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
products, bags, suitcases, handbags, knapsacks, umbrellas, carpets
and professional sport-wear are exempt
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20
EU textile draft
• EC is considering COMMISSION REGULATION (EU) …/… of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the
European Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals ("REACH")
as regards nonylphenol ethoxylates
• Proposal would establish a limit of 0.01% NPE by weight in
intentionally-treated textiles
39
US BPA bill
• US Senate is considering S.821, BPA in Food Packaging Right to
Know Act
• Bill would require the Secretary of Health and Human Services to
issue a revised safety assessment for food containers composed, in
whole or in part, of BPA
• Determine whether there is a reasonable certainty that no harm will
result from aggregate exposure to BPA through food containers or
other items composed, in whole or in part, of BPA
• Bill would require containers composed of BPA, to include a label
with the following statement: "This food packaging contains BPA, an
endocrine-disrupting chemical, according to the National Institutes of
Health."
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Massachusetts BPA bill
• Massachusetts Senate is considering S.1223, An Act prohibiting the
use of bisphenol-A in consumer products
• Per the bill, commencing January 1, 2016, no person, entity,
manufacturer, wholesaler, or retailer may manufacture, knowingly
sell, offer for sale, distribute for sale, or distribute for use, any toy,
child care article, bottle, cup, or other container, that contains
bisphenol A if that container is designed or intended to be filled with
any liquid, food, or beverage primarily for consumption from that
container
41
BPA added to Prop 65 list
• Effective May 11, 2015, the Office of Environmental Health Hazard
Assessment (OEHHA) added bisphenol A (CAS No. 80-05-7) to the
list of chemicals known to the state to cause reproductive toxicity for
purposes of the Safe Drinking Water and Toxic Enforcement Act of
1986 (Proposition 65)
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22
EN 71-12 draft available
• New draft available for EN 71-12 Safety of toys. Part 12. N-
Nitrosamines and N-nitrosatable substances
• Specifies the requirements and test methods for N-nitrosamines and
N-nitrosatable substances for:
– toys and parts of toys made from elastomers and intended for use by children under 36months;
– toys and parts of toys made from elastomers and intended to be placed in the mouth;
– finger paints for children under 36 months
• Regarding elastomers, up to now N-nitrosamines and N-nitrosatable
substances have only been detected in vulcanized materials
43
CEN issued revised edition of EN 12868
• CEN has issued a revised edition of EN 12868, Child use and care
articles - Methods for determining the release of N-Nitrosamines and
N-Nitrosatable substances from elastomer or rubber teats and
soothers, to a 2015 edition
• Specifies the methods for sample preparation and migration of
elastomer or rubber baby teats and for isolation, identification and
quantification of N-Nitrosamines and N-Nitrosatable substances
released from elastomer or rubber teats in contact with artificial
saliva salt solution
44
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23
Revised Taiwan food contact methods
• Taiwan's MOHW published revised food contact methods:
– “Methods of Test for Food Utensils, Containers and Packages – Test of Glass, Porcelain and Enameled Products” (MOHWU0009.02)
– "Food utensils, containers and packaging test methods - Inspection of rubber feeding apparatus (MOHWU0010.02)"
– "Food utensils, containers and packaging test methods - polypropylene plastic test (MOHWU0007.02)"
– "Food utensils, containers and packaging test methods -Polymethylpentene the plastic test (MOHWU0003.02)",
– "Food utensils, containers and packaging test methods - polyethylene plastic test (MOHWU0008.02)"
45
EU food contact study
• European Commission’s Directorate General Health and Food
Safety (DG SANTE) published news about an on-going “baseline
study” of food contact materials at the EC Joint Research Centre
• Aim is to provide background information for DG SANTE to assess
whether current European FCM regulations are efficient and
effective
• Launched in late 2014 and is scheduled for completion by early
2016
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24
Brazil draft on food packaging GMP
• Brazil's ANVISA held a public consultation on a draft resolution on
the Good Manufacturing Practices (GMP) for establishments
producing food packaging
• Currently, RDC No. 91/2001 establishes the sanitary regulations on
packaging and materials intended for contact with food
• There is no specific regulation on Good Manufacturing Practices
applicable to this sector
47
Chinese food contact draft
• China National Center for Food Safety Risk Assessment (CFSA)
has posted the draft General Safety Requirements for Food Contact
Materials and Products
• Main contents are detailed as follows:
– Basic requirements, in reference to GB 9685
– Control over non-intentionally added substances
– Management of substances with a migration limit lower than 0.01 mg/kg behind the barrier layer
– Management of composite materials and blended materials
– Requirements on production process
– For substances not directly in contact with food that have a barrier layer to effectively block from contact with food
48
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European plastic food contact draft
• European Commission's (EC) Directorate General for Health and
Food Safety notified of a Draft Commission Regulation amending
and correcting Regulation (EU) No. 10/2011 on plastic materials and
articles intended to come into contact with food
• Amendment changes the enacting terms, adds 8 substances to
Table 1 of Annex 1 (list of approved substances) and sets new limits
for aluminium, nickel and zinc
• Proposes to set migration limits for oligomers related to three
substances and would require that methods to detect these
oligomers are publicly available before the substances can be used
49
Canadian toxic substances proposal
• Environment Canada and Health Canada have proposed
Regulations Amending the Prohibition of Certain Toxic Substances
Regulations, 2012
• Would address different issues with respect to Canada's
management of five toxic substances to reduce harmful releases to
the environment:
– hexabromocyclododecane (HBCD);
– perfluorooctanoic acid, its salts, and its precursors (collectively referred to as PFOA);
– long-chain perfluorocarboxylic acids, their salts, and their precursors (collectively referred to as LC-PFCAs);
– polybrominated diphenyl ethers (PBDEs);
– and perfluorooctane sulfonate (PFOS).
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Statement on PFASs
• Over 200 scientists from 40 countries reached a consensus: The
entire class of highly fluorinated chemicals - also known as PFCs or
PFASs - should only be used when it is essential and there are no
suitable replacements
• Madrid Statement on Poly- and Perfluoroalkyl Substances (PFASs),
documenting this consensus, was published May 1 in Environmental
Health Perspectives (EHP), a high-impact, peer-reviewed scientific
journal
• Highly fluorinated chemicals such as C8 and its chemical cousins
are used in outdoor and fashion clothing, carpets, furniture,
cookware, food contact paper and even some cosmetics
51
Commentary POP bans under the Stockholm
Convention
• Chris Robertson from Edif ERA posted Expert Commentary in C2P
on three new bans on POPs under the Stockholm Convention
• Three international substance bans were adopted under the
Stockholm Convention on Persistent Organic Pollutants (POPs) at a
latest meeting of the “Conference of the Parties” (COP) in May
2015:
– Polychlorinated naphthalenes (mono to octa) (PCNs)
– Hexachlorobuta-1,3-diene; hexachlorobutadiene (HCBD)
– Pentachlorophenol and its salts and esters (PCP)
52
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27
European Parliament vote on conflict minerals
• European Parliament voted in favor of a mandatory monitoring
system for minerals originating from conflict zones
• European gold, tantalum, tungsten and tin imports from conflict
zones could be subjected to tougher surveillance procedures under
a new draft regulation voted on by the European Parliament
• MEPs in Strasbourg voted to enforce an obligatory monitoring
system for the whole supply chain of "conflict minerals"
53
Brazil enacts mercury requirements
• Brazil has enacted legislation on the production, import and
marketing of mercury, including the requirement to register and
complete metallic mercury report forms
• Pre-shipment approval of an import license is also required, via an
online application
• Mercury production relates to utility services, specifically in relation
to the treatment and disposal of solid and liquid industrial waste
54
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28
California finalized Priority Product Work Plan
• California's Department of Toxic Substances Control has finalized its 2015-17 Priority Product Work Plan
• Outlines DTSC's policy priorities and the types of products that may be evaluated over the next three years
• Provides stakeholders a level of predictability and serves as a signal to manufacturers who make products that fall into the following categories:
– Beauty/Personal Care and Hygiene
– Building Products: Paints, Adhesives, Sealants and Flooring
– Household/Office Furniture and Furnishings with perfluorochemicals or flame retardants
– Cleaning Products
– Clothing
– Fishing and Angling Equipment
– Office Machinery Consumable Products
55
China's Catalogue of Hazardous Chemicals 2015
• China's Catalogue of Hazardous
Chemicals 2015 has been implemented
• Enterprises should check if the products
are included in the Catalogue.
• The Catalogue outlines an enterprise's
obligations for:
– Registration of hazardous chemicals;
– Licensing for handling hazardous chemicals and
– GHS and SDS requirement
56
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29
South Korea allows 6-month grace period for PEC
• South Korean published its list of Priority
Existing Chemicals (PEC) subject to
registration under K-REACH
• Chemtopia has advised that importers
and manufacturers have a 6-month
transitional period (til 1 January 2016) to
submit their chemical confirmation
– The chemical confirmation is submitted after confirming a product contains PECs
• For more, download out our white paper,
"K-REACH: Devil is in the Detail"
57
Commentary on UK workplace scheme
• C2P data partner, Paul Goodman from Edif ERA, has added Expert
Commentary on the UK's Control of Substances Hazardous to
Health in the workplace (CoSHH) scheme
• All employers in the EU are required to comply with worker safety
legislation which includes the control of hazardous substances
• COSHH is a procedure to assess the risks from hazardous
substances and to determine a safe operating procedure that avoids
harm to workers
• Use or formation of any hazardous substance is covered by these
requirements
58
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30
New substances of very high concern
• ECHA has added new substances of very high concern (SVHCs)
added to the Candidate List
• series of mixed alkyl diesters (CAS 68515-51-5; CAS 68648-93-1)
• product with the trade name "karanal”
• 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-
benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
with ≥ 0.3% of dihexyl phthalate
• 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
[1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3- en-1-yl)-5-methyl-1,3-
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
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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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Compliance & Risks: Your partner in global
compliance
• We help our succeed in an ever-evolving regulatory environment
• Our webinars, like the Chemicals Quarterly, help clients to proactively respond to the latest proposed, enacted and amended regulations and standards globally
• Contact us to:
– register for Chemicals Quarterly;
– sign up for a demonstration and 30-day trial of our online regulatory platform, C2P; or
– schedule a “needs assessment” with one of our experts!
• E: [email protected]
• W: www.complianceandrisks.com
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