The document provides a summary of various global regulatory developments related to chemicals and restricted substances over the third quarter of 2013. Some key points covered include California launching its Safer Consumer Products program, proposed amendments to regulations on chemicals like TDCPP and BPA in toys in various jurisdictions, and updates on regulatory activities related to chemicals like phthalates from organizations like ECHA and EPA.

1. Chemicals Quarterly
Q3 2013
Stacey Bowers, MILS
Global Regulatory Specialist
s.bowers@complianceandrisks.com
3 October 2013
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2. Welcome to the Chemicals Quarterly!
• The latest proposed, amended and enacted regulations and
standards on restricted substances globally
• Broad coverage of products, countries and chemicals
o Each slide is a quick and dirty look
o If a given slide doesn’t apply to you, the next one may!
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3. CA launches Safer Consumer Products Program
• On 1 October 2013, DTSC launched California's Safer
Consumer Products (SCP) Program
• To kick it off, DTSC posted 2 lists of Candidate Chemicals
online
o The Informational Candidate Chemicals List includes chemicals
that may be named as Chemicals of Concern if they are identified
as part of a product-chemical combination listed as a Priority
Product
o The “Initial” Candidate Chemicals Informational List represents the
prioritized Candidate Chemicals that will be used for identification
of Priority Products
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4. CA launches Safer Consumer Products Program
• DTSC also posted a Toxics Information Clearinghouse (TIC)
website
o The TIC's is a decentralized system for collection, maintenance,
and distribution of information on specified chemicals
o The TIC provides a portal to multiple web-based sources of
chemical-specific information for hazard traits, toxicity endpoints,
and other properties
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5. WA proposes amendment to CSPA Reporting Rule
• Washington State's Department of Ecology is considering an
amendment to its Reporting Rule per the CSPA
• The proposed amendment would add TDCPP to the reporting
list of chemicals
• Additionally, the proposed amendment would remove n-butanol
from the reporting list
• Ecology expects to adopt the amendment around 16 October
2013, with the first reports due on 28 February 2015
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6. OR bill on chemicals of concern dies
• Oregon’s House Bill 3162 has died
• The Bill would have required the Oregon Health Authority to
maintain list of designated high priority chemicals of concern for
children’s health used in children’s products
• The Bill would also have required manufacturers of certain
children’s products to notify the authority regarding chemicals
on the list
• Democratic Senator Diane Rosenbaum, the majority leader,
hopes the Legislature will take up the issue again next session
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7. House bill to restrict flame retardants in children’s products
• The federal House of Representatives is
considering the “Decrease Unsafe Toxins Act”
• H.R. 2934 would amend CPSIA to prohibit flame
retardant chemicals in children’s cushioned
products, such as high chairs, strollers, infant
walkers and booster seats
• The bill defines “flame retardant chemicals” to
mean organohalogen or organophosphorous
compounds, such as PBDEs
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8. EC proposes limits for BPA & flame retardants in toys
• In mid-July, the EC notified the WTO of 2 drafts to amend the
Safety of Toys Directive
o One would establish a migration limit of 0.1 mg/l of BPA, in
accordance with EN 71-10 and EN 71-11
o The other would establish limits of <5 ppm of each of the
chlorinated flame retardants, TCEP, TCPP and TDCP, in toys
• The draft Directives are open for comments for 60 days
• If enacted, they will enter into force 18 months after adoption
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9. ECHA consultation on BPA
• ECHA launched a public consultation to amend the harmonized
classification and labeling of BPA, from reproductive toxicity
category 2 to reproductive toxicity Category 1B
• The consultation was undertaken in response to a French
proposal
• The proposal is focused on the adverse effects on sexual
function and fertility, not on developmental toxicity or other
hazard classes
• The comment period ends 11 October 2013
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10. FDA amends BPA regulations
• The US FDA amended 21 CFR 175,
to remove provisions for BPA-based
epoxy resins as coatings in packaging
for infant formula
• The Rule was enacted because these
uses have been abandoned by the
industry
• The Rule took effect 12 July 2013
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11. Philippine bills on toxic chemicals in toys
• The Philippine House and Senate are considering 4 bills to
restrict toxic chemicals in toys, school supplies and childcare
articles
• HB 62, HB 220 and HB 1920, and SB 1095 were each
proposed in July
• The bills call for FDA to create a list of chemicals and
substances which cause or may cause harm, injury or death,
such as heavy metals, phthalates and BPA
• The bills would also require labeling to disclose and identify
chemicals and substances
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12. EPA delays phthalates report pending CPSC report
• According Plastics Today, EPA is delaying its review of
phthalates, until a separate review is completed by CPSC
• The EPA review would be conduced per its DfE program
o The program helps consumers, businesses and institutional
buyers identify products that are safer for the environment
• The CPSC review is being conducted by the Chronic Hazard
Advisory Panel (CHAP), as established by CPSIA
o The CHAP is studying effects on children’s health from phthalates
and phthalate alternatives in toys and childcare articles
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13. Environment Canada calls for phthalate data
• Environment Canada issued a notice calling for data on the use
of several phthalates, including BBP, DBP, DEHP and DNOP, in
2012
• The notice applies to anyone who manufactured, imported or
used a listed substance, at a total quantity greater than 100 kg,
at a concentration >0.001% by weight, during the calendar year
o The notice applies to substances whether alone, in a mixture or in
a product, or in a manufactured item, including products for
children under 6, food contact articles, clothing and other
consumer products
• Data must be provided by 13 November 2013
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14. South Korean notice on toxic substances in children’s products
• On 28 September, South Korea's Ministry of Environment
enacted Notice No. 2012-195, establishing restrictions on toxic
substances in children's products, as follows:
o DNOP:


Transition due to oral exposure: ≤ 9.90×10/cm2/min,
Transition due to dermal exposure: ≤5.50×10/cm2/min
o DINP:


Transition due to oral exposure: ≤ 4.01×10/cm2/min
Transition due to dermal exposure: ≤2.20 x 10/cm2/min
o NP: ≤0.1%
o TBT compounds: ≤0.1%
o The Notice will take force in one year
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15. ECHA issues final report on DIDP & DINP
• ECHA has reviewed the scientific evidence on the risks posed
by articles containing DINP and DIDP
• Currently, these phthalates cannot be used in toys and
childcare articles which can be placed in the mouth by children
• ECHA asserts, if the restriction were lifted, a risk from the
mouthing of toys and childcare articles with DINP and DIDP
cannot be excluded
• ECHA therefore concludes there is no evidence that would
justify a re-examination of the existing restriction
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16. TIA survey about proposed lead restrictions in Canada
• The US TIA is surveying its members on a proposed expansion
of Canada’s restrictions on lead in toys
• Under the proposal, the 90 ppm limit on lead in toys for children
three and under would expand to toys for children 14 and under
• TIA’s survey asks whether the proposed expansion would:
o increase testing costs;
o force members to stop selling toys in Canada; or
o reduce the number of toys that they sell in Canada
• The survey is open through 7 October 2013
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17. EU amends restrictions on barium in toys
• The EU amended the Toy Safety Directive, to further restrict
migration limits for barium in toys
• The amendments were undertaken after a review by SCHER
• The amended limits are as follows:
o 1,500 ppm in dry, brittle, powder-like or pliable toy material
o 375 ppm in liquid or sticky toy material
o 18,750 in scraped-off toy material
• These limits are also reflected in EN 71-3:2013,
which has been “harmonized” per the Directive
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18. ECHA called for info on cadmium in plastics
• ECHA called for information on the use of cadmium and
cadmium compounds, in particular cadmium-based pigments
in plastic materials
• The survey is intended to assess the need for expanding the
current restriction on cadmium, to cover plastics that have not
yet been restricted per REACH
• The comment period ended 29 August 2013
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19. Denmark to enforce chemical restrictions
• The Danish Minister of Environment has committed to spend
20 million DKK on enforcement in the next three years
• Under its “Chemistry Control – Clean childhood” program, the
Minister will inspect container ships filled with imported
products
• Inspections will focus on consumer products, including toys,
children’s apparel and electronic products
• The aim of the Program is to raise awareness of SVHCs
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20. ECHA calls for comments on NPs, NPEs & NMP
• On 19 September 2013, ECHA initiated a public consultation for
the restriction of NPs, NPEs and NMP
• The consultation follows submissions by Sweden and The
Netherlands
o The Swedish report proposed a restriction on textile articles that
can be washed in water, if they contain NPs or NPEs exceeding
100 mg of the substance per kg of textile
• Comments must be received by 18 March 2014
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21. OECD survey on risk of chemicals to children's health
• OECD presented a report on methodologies and tools used to
assess risk of chemicals to children's health
• The report is based on a survey of governments, universities,
and industry and international organizations from countries
including the EU, Australia, Italy, Denmark, Turkey and South
Korea
• It covers:
o
o
o
o
o
definitions of terms,
hazard and exposure assessments,
risk characterization,
cohort studies and
combined exposure to multiple chemicals
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22. ECHA considers 7 SVHCs under REACH
• In response to dossiers submitted by Austria, Germany, the
Netherlands and Sweden, ECHA is considering 7 possible
SVHCs, including:
o
o
o
o
o
o
Cadmium sulphide
DHP
C.I. Direct Red 28
C.I. Direct Black 38
Lead di(acetate)
Trixylyl Phosphate
• Comments must be received by 17 October 2013
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23. ECHA updates its chemical Navigator tool
• The Navigator is intended for stakeholders, including
manufacturers, importers and producers of articles
• During a Navigator session the user answers a series of
questions:
o whether the user manufactures or imports the substance,
o at what tonnage, and
o for what use
• The tool helps determine possible obligations under the
REACH and CLP regulations
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24. Auto industry petitions ECHA on SVHCs & nanomaterials
• The auto industry has written ECHA requesting chemicals listed
as SVHCs and nanomaterials be given unique substance
identifiers
• The European Automobile Manufacturers Association (ACEA)
and European Association of Automobile Suppliers (CLEPA)
assert, variable naming of chemicals is impeding industry’s
ability to comply with REACH
• The organizations urge ECHA to include a unique identifier,
such as a CAS or EC number, to help to differentiate them from
the bulk forms of materials
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25. Indian Ministry calls for “REACH-like legislation”
• C&R data partner, Chemical Watch, reports that India’s Ministry
of Chemicals and Fertilizers is calling for “REACH-like
legislation”
• A draft national chemical policy was issued in March, with
responses due by end April
• The draft policy calls for consolidation of existing legislation and
addressing:
o registration of substances;
o a national inventory;
o restricting and prohibiting substances
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26. OECD addresses manufactured nanomaterials
• OECD issued a Recommendation on safety of manufactured
nanomaterials
o Manufactured nanomaterials are chemical particles that exhibit
new characteristics, in contrast to the same material without
nanoscale features
• OECD advised Member Countries to apply existing
international and national chemical regulatory frameworks to
manufactured nanomaterials
• It also advised use of the OECD Test Guidelines for the Safety
Testing of Chemicals
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27. Oeko-Institut reports on 7 RoHS exemption requests
• The Oeko-Institute has launched a consultation to review 5
exemption requests under RoHS
• The exemptions relate to:
•
•
•
•
•
Cadmium in LEDs
Cadmium in light control materials
Lead in PVC in electrochemical sensors
Lead in solder in heart-lung machines
Mercury in electrical connectors
• The consultation ends on 11 November 2013
• C&R data partner, Paul Goodman, from ERA Technology Ltd, is
monitoring the consultations closely
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28. RoHS2 labeling causes confusion
• C&R data partner, Leigh Holloway, from eco3, reports the new
labeling requirements per RoHS2 (aka the RoHS Recast) have
caused confusion within the E&E industry
• Under the first incarnation of RoHS, industry used “ad-hoc”
symbols and verbiage to demonstrate compliance
• With the Recast, the CE Mark is the only permitted RoHS
compliance mark
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29. IEC updates database on material declaration
• The IEC updated its IEC 62474 database on material
declaration in electrotechnical industry
• The database is intended to be consulted in tandem with
IEC 62474, on material declaration of products in the
electrotechnical industry
• The database specifies:
o what substances, substance groups and material classes that
need to be included in material declarations; and
o to software developers, specifications on the data format for the
exchange of material declaration data
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30. South Africa phases out PCBs
• South Africa issued a Notice to phase out PCB materials and
PCB-contaminated materials
• Per the Notice, it is prohibited to:
o use, process or produce PCB materials or PCB-contaminated
materials;
o import PCB materials or PCB-contaminated materials or PCB
waste into the Republic of South Africa, or export PCB materials
or PCB-contaminated materials from South Africa; or
o sell PCB materials or PCB-contaminated materials in South Africa
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31. EPA expands Safer Chemical Ingredients List
• EPA added 130 chemicals to its Safer Chemical Ingredients List
o Included are 119 chemicals used in commercial and consumer
cleaning products
• The List serves as a guide for DfE-labeled products, which
must meet rigorous, scientific standards for protecting human
health and the environment
• It also serves as a resource for:
o manufacturers making safer products;
o health and environmental advocates encouraging
safer chemicals; and
o consumers seeking safer products
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32. EPA extends deadline for comments on formaldehyde in wood
• In June, EPA issued a proposed rule to
establish formaldehyde emissions
standards for composite wood products,
per TSCA
• The proposed standards are identical to
those in place in California
• In August, EPA extended the comment
period to 9 October 2013
• EPA has received 16 comments, from
stakeholders such as the AAP, CEA,
Georgia-Pacific & IKEA
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33. CA ARB proposes amendments to VOC requirements
• The California ARB proposed amendments to several of its
regulations on VOCs, including:
o Antiperspirants and Deodorants Regulation
o Consumer Product Regulation
o Aerosol Coating Products Regulation
• The proposed amendments would lower the impacts VOC
emissions have on formation of ground-level ozone
• If fully implemented, VOC emissions would be reduced by
about 4 tons per day statewide
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34. No movement on proposed TSCA amendments
• In April 2013, the late Senator Frank Lautenberg (D-NJ)
proposed two bills to amend TSCA, S.696 and S.1009
• The bills would amend TSCA to:
o protect the health of the public and the environment from chemical
substances;
o promote safer alternatives;
o require chemicals to meet a risk-based safety standard; and
o require companies to provide health and environmental
information for chemical substances
• The bills have not moved since they were proposed
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35. EPA SNUR on LCPFAC chemicals for use in carpets
• EPA issued a SNUR, per TSCA, to report all new uses and
imports of carpets containing long-chain perfluoroalkyl
carboxylic (LCPFAC) chemicals
• The Rule requires manufacturers, importers or processors of
any LCPFACs for use in carpets to notify EPA at least 90 days
in advance
• This notification period is designed to allow the agency to limit
these chemicals, due to risk to humans, animals and the
environment
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36. Russia amends its restrictions on ODS
• In July, the Russian Federal Assembly adopted Law
No. 226-FZ amending the law on environmental
protection
• The Law will significantly increase control over the
production, use and disposal of ozone depleting
substances (ODS)
• The Law enters into force on 1 January 2014
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37. AAFA publishes 13th edition of its RSL
• AAFA has revised its RSL to the 13th edition, in conjunction
with the International Product Safety & Restricted Substances
Conference in Jakarta, Indonesia
• The RSL covers restricted substances in apparel, footwear and
home textiles, providing the industry with "...clear and concise
information on the newest developments in global product
safety and chemical management standards”
• The RSL was updated to reflect changes spurred by REACH,
as well as other US state and global regulations.
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38. AFIRM revises Restricted Substances Guidance
• The Apparel and Footwear International RSL Management
(AFIRM) Group issued Version 2 of its Restricted Substance
Guidance
• The Guidance is a review of all AFIRM brand RSLs
o AFIRM members include Adidas, Carhartt, Gap,
Gymboree, J. Crew and other leading brands
• The Guidance assists and guides supply-chain
participants with product quality and safety, and
reduced environmental impact
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39. EU’s Biocidal Products Regulation takes force
• The EU’s Biocidal Products Regulation took force 1 September
2013
• The Regulation concerns biocidal products, used to protect
humans, animals, materials or articles against harmful
organisms, like pests or bacteria, by the action of active
substances within
• All biocidal products require an authorization before they can be
placed on the market, and the active substances contained
within must be previously approved
• The Regulation also aims to harmonize the market at the EU
level
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40. Prop 65 settlements on flame retardants
• In September 2013, two Proposition 65 settlements were
reached on TDCPP, TCEP, and TDBPP in children’s products
o Car seats with foam padding
o Changing pads with polyurethane foam
• Each calls for “no detectable amount," measured as 25 ppm
each of TDCPP, TCEP, and/ or TDBPP in any material,
component, or constituent of the product
• The car seat settlement provides for warning labeling through
31 December 2013
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41. Prop 65 settlements on flame retardants
• This comes after an April 2013 settlement, restricting flame
retardants in foam-cushioned pads for children and infants,
such as rest mats
• This settlement restricts any covered product in which the
polyurethane foam has been treated with TDCPP
• Further, starting in June, it restricts any covered product in
which the polyurethane foam has been treated with one of a
series of chemical flame retardants, including TDCPP, TCEP,
TCPP, PentaBDE, OctaBDE and DecaBDE
• Labeling is not allowed in this settlement
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42. CEH actions against cocamide DEA in cosmetics
• CEH testing found cocamide DEA, a cancer-causing chemical,
in 98 shampoos, soaps and other personal care products
o Many tested products contained <10,000 ppm cocamide DEA,
with one containing <20,000 ppm
• Per California Proposition 65, the organization filed a lawsuit
against four retailers selling products containing cocamide DEA
• The organization also sent legal notices to more than 100 other
companies that produce and/ or sell products containing the
chemical
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43. OEHHA lists chemicals under Prop 65 consideration
• California’s OEHHA published a “tracking table” of chemicals
under consideration for the Proposition 65 list
• The table lists:
o
o
o
o
o
o
the chemicals,
the endpoint (toxic effect),
the authoritative body,
the basis for the possible listing,
the status of the chemical on the Prop 65 list, and
the next step in the listing process
• OEHHA will update the list on a regular basis
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44. CA Prop 65 reforms tabled until 2014
• The Sacramento Business Journal reports negotiations to
reform California Proposition 65 have stalled
• Business leaders, environmentalists, attorneys, consumer
organizations and state agencies hoped to introduce proposed
amendments in the California Legislature before the midterm
recess on 13 September
• Stakeholders disagreed over reforms, including “safe harbor”
levels
• Meanwhile, the Legislature is still considering AB 227, to
provide a 14-day grace period for violations of Prop 65
warnings
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45. CA Prop 65 60-day notices in Q3 2013
• California’s Attorney General received 248 60-day notices
• Chemicals
o DEHP was the most-notified chemical, with 111 notices
o Lead and lead compounds were the second-most notified
chemical, with 86 notices
o TDCPP was third-most notified, with 23 notices
• Products
o Personal care products, such as shampoo, soaps, shower gels
and bath gels, were most-notified, with 97 notices
o Upholstered furniture was second-most-notified, with 56 notices
o Eyewear, including sunglasses, were third-most-notified, with 32
notices
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46. Recalls in Q3 2013
• CPSC announced 69 product recalls; 2 were due to chemical
hazards:
o Youth beds, due to excess lead in paint
o Outdoor furniture, due to excess lead in paint
• The EU announced 553 RAPEX notifications; 255 were due to
chemical risk, including:
o
o
o
o
Plastic tolls excess DEHP
Jewelry containing excess nickel
Footwear containing excess chromium (VI)
False nails containing DBP
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47. Recalls in Q3 2013
• Health Canada announced 65 consumer product recalls; 4
were due to chemical hazards, including:
o Reed diffusers which pose a high level of toxicity through
inhalation
o Air horns, which do not have mandatory consumer chemical
product labeling
• ACCC announced 53 consumer product recalls; none were due
to chemical hazards
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