The latest proposed, enacted & amended restrictions & prohibitions on chemicals globally

1. Chemicals Quarterly
Q4 2016
Presented by Stacey Bowers, MILS
8 February 2017
1

2. California Safer Consumer Products update
• California's Department of Toxic Substances Control (DTSC) is
considering:
– Aquatic impacts from continued uses of nonylphenol ethoxylates and
triclosan;
– Health and safety impacts of chemicals in nail products and
– Perfluoroalkyl, polyfluoroalkyl substances (PFASs) in carpets, rugs,
upholstered furniture
• DTSC is also considering comments on its Draft Alternatives
Analysis Guide
• DTSC will host a day-long workshop to facilitate stakeholder
engagement on 2 March 2017
2

3. New York Bill SB 378 on lead in holiday
decorations
• New York State considering SB 378, An Act to amend the public
health law, in relation to holiday decorations containing lead
• Applies to "holiday decorations“: artificial Christmas trees, plants,
flowers/ wreaths, lights, stockings, candles, figurines, bells
• On each holiday decoration that:
– Has paint or similar surface-coating material thereon; or
– Is made of any plastic material, such as polyvinyl chloride, which
contains more than .06 of 1% of metallic lead,
• Warning label shall state: "WARNING: CONTAINS LEAD. MAY BE
HARMFUL. MAY GENERATE DUST CONTAINING LEAD."
3

4. EEC amended regulation on packaging safety
• Eurasian Economic Commission (EEC) approved amendments to
Regulation on the safety of packaging
– Reduction of formaldehyde, acetone, harmful substances in packaging
– Determines methods to detect harmful substances
• Set limits of concentrations of metals in packaging:
– Lead: 0.03 mg per cubic decimeter (dm3);
– Nickel and chromium: 0.1mg/dm3; and
– Arsenic: 0.05 mg/dm3
• Part of EEC's program of standardization across member states:
Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia
4

5. EEC enacts ‘RoHS’
• Eurasian Economic Commission (EEC) enacted Technical
Regulation on Restriction of Hazardous Substances in Electrical and
Electronic Equipment
• Aligned with EU Directive 2011/65/EU on the Restriction of
Hazardous Substances (RoHS)
– Protects the environment and human health and safety
– Establishes requirements for allowable concentrations of lead, mercury,
hexavalent chromium, cadmium, polybrominated biphenyls,
polybrominated diphenyl ethers in electronic and electrical products
• Entry into force is 1 March 2018
5

6. Colombia enacts Decree on mercury in products
• Colombian Ministry of Commerce, Industry and Tourism enacted
Decree No. 2133/2016 to establish control measures for importation,
sale of mercury, mercury-containing products
– Includes mercury sulphates, organomercury compounds, batteries
(electrical, mercuric oxide, cylindrical, manganese dioxide, alkaline,
silver oxide, button with mercury content greater than 2%)
• To import/market listed products, must register with Ministry
• Entered into force 22 December 2016
6

7. Mexico draft official standard on mercury,
cadmium in batteries
• Draft Mexican Official Standard PROY-NOM-212-SCFI-2016:
Primary cells and primary batteries - Maximum permissible mercury
and cadmium limits - Specifications, test methods and labeling
• Establishes maximum permissible mercury and cadmium limits, and
battery labeling requirements
• Does NOT cover cells, batteries marketed as part of electronic/
electrical product
7

8. Swedish analysis of chemicals in electronics
• Swedish Chemicals Agency, Kemi, shows that frequently,
inexpensive consumer electronics contain banned chemicals
• Kemi analyzed 154 electrical/ electronic low-price products
– Analyzed products: Headphones, bicycle lamps, USB connectors
– Total of 84 companies’ products inspected
• Excessive levels of banned chemical substances found in 58
products (38%)
• High levels of lead found in solder joints inside several products
• Several plastic parts contained phthalates
8

9. Europe proposed regulation of PFOA
• European Commission is considering a Draft Commission
Regulation amending Annex XVII to REACH as regards
perfluorooctanoic acid (PFOA), its salts and PFOA-related
substances
• Restricts manufacturing, use, placing on market of PFOA, its salts,
PFOA-related substances as substance on its own, as constituent of
other substances, in mixtures, in articles/ part, in concentration
equal to/ greater than 25 ppb of PFOA or 1000 ppb of one/
combination of related substances
9

10. Europe proposed regulation on lead in PVC
• Proposal to restrict lead compounds in PVC, PVC articles stabilized
with lead compounds
• Restriction may be broad or specific
• European Chemicals Agency (ECHA) committees performing
conformity check
• Dossier available on website to increase transparency, help
stakeholders prepare for six-month public consultation
• If it passes, public consultation expected February 2017
10

11. ECHA case studies on substitution of hazardous
chemicals
• European Chemicals Agency (ECHA) published two case studies
promoting benefits of substituting hazardous chemicals
– Adidas shares best practice from working with supply chain to replace
per- and polyfluorinated chemicals (PFCs) in sporting goods
– INERIS, French National Competence Centre for Industrial Safety and
Environmental Protection, present website supporting companies trying
to substitute bisphenols
11

12. Canada issues Ministerial Condition on 1,2-
cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl)
ester
• Canada's Minister of the Environment, Minister of Health issued
Ministerial Condition calling for manufacturers to stop using 1,2-
cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester in:
– Toys/ child care articles;
– Cosmetics/ drugs or
– Natural health products
12

13. Canada recommendation of 2-(2-methoxyethoxy)
ethanol in surface coating materials
• Canada recommended surface coating materials contain total
concentration of 2-(2-methoxyethoxy) ethanol (DEGME) not to
exceed 10,000 mg/kg when wet sample is tested in accordance with
method conforming to good laboratory practices
• Applicable to consumer products surface coating materials
containing DEGME
13

14. Canada proposed amendment regarding ozone-
depleting substance
• Environment Canada Proposed Amendment to the Ozone-depleting
Substances and Halocarbon Alternatives Regulations
• Reduce supply of HFCs entering Canada, demand for HFCs in
products, thereby averting future HFC releases into environment:
– Reduce Canadian GHG emissions
– Help limit global warming
– Put Canada in position to ratify amendment to Montreal Protocol
• Combine phase-down of consumption of HFCs with prohibitions on
import, manufacture of products containing HFCs above limit,
including air conditioning equipment, refrigeration equipment, foam
products, aerosols
14

15. Seventh Generation supports ingredient
disclosure legislation
• Seventh Generation's Martin Wolf: Company will lobby for state,
federal legislation to mandate chemical disclosure of products
– New York, California expected to reintroduce passed failed bills
– Reintroduction of federal Cleaning Product Right to Know Act also
expected in 2017
15

16. Costco stakeholders want more diligence
regarding toxins
• Investors, consumers want Costco to improve efforts against toxic
chemicals
• Group to deliver over 35,000 signed petitions from members,
consumers concerned about Costco’s lack of comprehensive safer
chemicals policy
• Costco to provide details on initiative to address toxic chemicals in
products
16

17. Azo dyes found in dust
• Researchers from the from the University of Saskatchewan found
azo dyes containing brominated compounds make up much dust in
homes
• Azo colorants are used in textiles, from apparel to upholstered
furniture
• Approximately 85% of brominated compounds found in dust
samples from azo dyes
17

18. United States Senate Bill 342 on asbestos
• US Senate Bill 342, to amend Toxic Substances Control Act to ban
"manufacture, processing, use, distribution in commerce, and
disposal" of all forms of asbestos in any product
• Environmental Protection Agency (EPA) would have 18 months to
promulgate implementing rule
18

19. Canada notice of intent to develop regulations
respecting asbestos
• Canada's Departments of Environment, Health sending notice that
development of draft regulations to ban manufacture, use, sale, offer
for sale, import, export of asbestos, asbestos-containing products
• Asbestos is currently managed under various federal acts and
regulations
– Consumer products made of asbestos or containing asbestos fibers are
prohibited and regulated under the Asbestos Products Regulations
• The proposed regulations under CEPA 1999 would seek to further
manage and control asbestos and asbestos-containing products in
Canada
• Expected to be published in Canada Gazette December 2017
19

20. Danish report on phthalate migration rates
• Denmark’s MST identified, discussed lack of correlation between
migration rates and concentrations of phthalates in soft PVC articles
• Covered essential literature from 1998 to 2015, with focus on
Denmark, the Netherlands, Austria, Sweden, Germany, Great
Britain, Turkey, Canada, Japan, the US
• Recommended migration rates for calculation of risk of exposure to
phthalates until further evidence available:
– DEHP 10 µg/cm2/h
– DINP 13 µg/cm2/h
– DIBP 13 µg/cm2/h
– DBP 13 µg/cm2/h
– BBP 12 µg/cm2/h
20

21. New York Bill A 994 on phthalates in children’s
products
• Prohibit person/ entity from manufacturing, distributing, selling toys/
child care products containing DEHP, DBP or BBP in concentrations
greater than 0.1%
21

22. Consumer Product Safety Commission report and
phthalate testing
• U.S. Consumer Product Safety Commission (CPSC) report,
Exposure Assessment: Potential for the Presence of Phthalates
in Specified Materials at Concentrations Above 0.1 Percent
• Examined 11 plastics for concentrations greater than 0.1% of 10
phthalates: DEHP, DBP, BBP, DINP, DIDP, DNOP, DIBP, DPENP,
DHEP and DCHP
– First six phthalates currently regulated in children’s toys, child care
articles
– Others under consideration based on recommendations of Chronic
Hazards Advisory Panel
• Found that nine plastics would not contain the specified
phthalates at levels greater than 0.1%
• CPSC to evaluate whether to require third-party testing to assure
compliance with CPSIA
22

23. U.S. Food and Drug Administration amending food
additive regulations
• U.S. Food and Drug Administration (FDA) amending food additive
regulations
• Two perfluoroalkyl-containing substances that also repel oil/ water,
no longer permitted in paper/ paperboard in contact with aqueous/
fatty foods
23

24. Draft guidance on infant formula, human milk food
contact substances
• U.S. Food and Drug Administration (FDA) drafted guidance,
Preparation of Food Contact Notifications for Food Contact
Substances in Contact with Infant Formula and/or Human Milk
• Assist industry with preparation of food contact notification (FCN)
submissions for evaluation of safety of food contact substances
(FCSs) that will be in contact with infant formula and/or human milk
24

25. Europe: Migration of substances in tableware
• Food Additives & Contaminants: Part A, published article on
formaldehyde and melamine migration from plastic, amino resin
tableware
– Studied 72 new pieces of tableware sold in Italy, 18 consumer-used
pieces
– Select tableware articles measured again, after artificial aging
• European Union (EU) Specific Migration Limit (SML) exceeded for
FA (15 mg/kg) or MA (2.5 mg/kg) in >20% of new tableware
– Artificially aged selection: results showed that with low/ no visible signs
of deterioration, significant migration can still occur
– EU SML exceeded only in one of used tableware articles; however, FA,
MA migration detected in > 60% of these pieces
25

26. Belgium regulation on coatings
• Belgian Federal Public Service (FPS) Public Health and Safety of the
Food Chain and Environment released “Royal Decree on varnishes and
coatings intended to come into contact with foodstuffs”
• Listed substances may be intentionally used in coatings meant to be in
contact with food:
– Substances in Annex I of Regulation (EU) No 10/2011 on plastics;
– Substances approved by another EU Member State;
– Substances approved by European Food Safety Authority (EFSA);
– Substances that do not migrate to a detectable amount in food; and
– Substances not classified as carcinogenic, mutagenic, toxic to reproduction
(CMR), NOT in nanoform
• Global migration limit set to 10 mg per dm2
• Specific migration limits should be followed unless unavailable, in which
case, individual migration should be set to generic specific migration
limit of 60 mg/kg
• Coatings, varnishes should be accompanied by Compliance Statement
26

27. Netherlands' amended Commodities Act
Regulation now in effect
• Netherlands' amended technical requirements for food contact
materials and articles, per Commodities Act Regulation, came into
effect 1 January 2017
• Changes include:
– Amending list of authorized substances for plastics, paper and
cardboards, metals, coatings;
– Amending specific migration limit (SML) for some organic chemicals
used in plastic food contact materials (FCMs);
– Amending SML for total zirconium compounds in plastics to become
less stringent;
– Amending SML for zirconium in glass and glass ceramics to become
less stringent; and
– Requiring use of 1.5% citric acid or foodstuff itself for specific migration
of zirconium in passivated metals; SML for zirconium in these food
contact materials, articles now less stringent
27

28. Uruguay proposed regulation on food contact
packaging, equipment
• Uruguay's proposal on plastic packaging and equipment that comes
into contact with foodstuffs
– Part I lists reference number, CAS number, substance, restrictions
and/or specifications for use, for additives used in manufacture of plastic
packaging, equipment that come into contact with foodstuffs;
– Part II concerns products obtained through bacterial fermentation;
– Part III covers specifications; and
– Part IV contains notes on "Restrictions and/or specifications"
28

29. Algeria published Decree on food contact
materials
• Algeria Executive Decree A 16-299 laying down conditions and terms of
use objects and materials to be brought into contact with food as well
as cleaning products of these materials
– Products must be safe, not harm health, safety, consumer interests
– Objects/ materials made from: Plastics including varnishes, coatings;
Regenerated cellulose; Elastomers, rubber; Ion exchange resins; Paper,
cardboard; Ceramics; Glass; Metals, alloys; Timber including cork; Textiles;
Paraffin waxes, microcrystalline waxes; Printing ink; Silicone; Glues
• Manufacturers, importers required to provide certificate of compliance
issued by accredited organization, attesting compliance with
requirements
• Labeling, presentation must meet requirements, must not mislead
consumer
• Enter into force six (6) months after date of publication in Official
newspaper
29

30. Chinese standard on additives in food contact
materials published
• China's National Health and Family Planning Commission (NHFPC)
released final version of GB 9685:2016, Standard for uses of
additives in food contact materials
• Goes into effect 19 October 2017
• Contains requirements for food contact materials made of enamel,
ceramic, glass, plastics (resin), paper/ paperboard, metal, painting/
coating, rubber, etc.
30

31. China National Safety Standards on food contact
materials, articles
• China's National Health and Family Planning Commission (NHFPC) issued
notice on 53 new, amended national safety standards on food contact materials,
including:
– GB 4806.1:2016 National food safety standards for food contact materials and articles
- General safety requirements
– GB 4806.3:2016 National Food Safety Standard enamels
– GB 4806.4:2016 National Food Safety Standard ceramics
– GB 4806.5:2016 National Food Safety Standard glassware
– GB 4806.6:2016 National food safety standards for food contact plastic resin
– GB 4806.7:2016 National food safety standards for food contact plastic materials and
products
– GB 4806.8:2016 National food safety standards for food contact paper and board
materials and articles
– GB 4806.9:2016 National food safety standards for food contact materials and metal
products
– GB 4806.10:2016 Food safety standards for food contact coatings and coating
– GB 4806.11:2016 Food safety standards for food contact materials and rubber
products
31

32. European report on BPA in food contact materials
• Members of European Parliament (MEPs) support Environment
Committee (Envi) report calling for ban of bisphenol A (BPA) in all
food contact materials (FCM)
• Criticizes major gaps in European Union legislation
• Calls for harmonized regulation for all FCMs
• Priority given to paper, board due to high market penetration
• Apply pressure to Commission to act
32

33. Mexico amended standards on heavy metals in
ceramic- and glassware
• Mexico's Ministry of Health amended mandatory standard on lead
and cadmium in glazed pottery, porcelain and glassware to NOM-
231-SSA1-2016
• Consistent with international standards:
– ISO 6486-1:1999, Ceramic ware, glass-ceramic ware and glass
dinnerware in contact with food - Release of lead and cadmium - Part 1:
Test method; and
– ISO 6486-2:1999, Ceramic ware, glass-ceramic ware and glass
dinnerware in contact with food - Release of lead and cadmium - Part 2:
Permissible limits
33

34. New ECHA restrictions proposed
• European Commission (EC) requested European Chemicals Agency
(ECHA) to evaluate elements of REACH Annex XVII restrictions on
polycyclic-aromatic hydrocarbons (PAHs) in rubber/ plastic
components of articles (entry 50) and lead in jewelry to support
Commission in future reviews
• EC also requested ECHA to develop Annex XV restriction dossier
for uses of octamethylcyclotetrasiloxane (D4) and
decamethylcyclopentasiloxane (D5) in cosmetics products not
covered by UK’s restriction proposal from April 2015
34

35. New Jersey bills on heavy metals in children’s
products
• New Jersey bills, S2646 and A731, to prohibit sale of certain
children's products containing lead, mercury, cadmium
• Apply to toys or play equipment designed/ intended solely/ primarily:
– For care of/ use by children; or
– To come into contact with children while being used
• Define "child" to mean under six years old
• No person shall sell, offer for sale, distribute, import, manufacture
children’s products intended for use by child under 6 years
containing/ composed of/ made with lead/ mercury/ cadmium
35

36. Canada proposes Consumer Products Containing
Lead Regulations
• Part of Health Canada's Lead Risk Reduction Strategy for
Consumer Products (LRRS), agency proposed Consumer Products
Containing Lead Regulations
• Currently, no specific regulatory lead content limits for:
– Products intended for use in learning or play for children between 3
years and under 14 years;
– Children’s clothing and accessories and
– Products whose primary purpose is to facilitate relaxation, sleep,
hygiene, carrying, transportation of child under 4 years
• Would expand the scope of Consumer Products Containing Lead
(Contact with Mouth) Regulations to include total lead limit of 90
mg/kg for these products
36

37. Canada proposed amendment to Children's
Jewelry Regulations
• Proposed amendments to the Children’s Jewelry Regulations would:
– Replace current 600 mg/kg total lead limit and 90 mg/kg migratable lead
limit with 90 mg/kg total lead limit for all children’s jewelry items; and
– Add limit of 130 mg/kg total cadmium for children’s jewelry items small
enough to be enclosed in small parts cylinder
37

38. European draft amendment on lead in toys
• On 17 October 2016, Council of the European Union (EU) decided
not to oppose draft amendment of Directive 2009/48/EC, which
would substantially strengthen limit values for lead in toys to:
– 2.0 ppm in dry, brittle, powder-like or pliable toy material;
– 0.5 ppm in liquid or sticky toy material and
– 23 ppm in scraped-off toy material
• New evidence shows that level of protection against lead exposure
afforded by provisions established in 2009 no longer adequate
• Council's assent strong indicator that amendment will be adopted,
unless EU Parliament objects
38

39. EU requests opinion on aluminum in toys
• European Union issued Request for a Scientific Opinion on the
Tolerable Intake of Aluminium with Regards to Adapting the
Migration Limits for Aluminium in Toys
• Scientific Committee on Health and Environmental Risks (SCHER)
is asked:
– To review available data on toxicity of aluminum, taking into account
different tolerable intake levels for aluminum established by EFSA in
2008 and JECFA in 2011 and
– To advise on tolerable intake level for aluminum, based on most recent
data, adapt migration limits for aluminum in Directive 2009/48/EC,
taking account of exposure to aluminum from sources other than toys
• Preliminary opinion – May 2017
• Final opinion – Autumn 2017
39

40. European Committee for Standardization updates
standard on N-nitrosamines in toys
• The European Committee for Standardization (CEN) published 2016
edition of EN 71-12, Safety of toys - Part 12: N-Nitrosamines and N-
nitrosatable substances
• Specifies 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 36 months, like balloons;
– Toys and parts of toys made from elastomers and intended to be placed
in the mouth, like teethers and
– Finger paints for children under 36 months
40

41. New York Bill A 1884 on formaldehyde in children's
products
• New York Assembly proposed Bill A 1884, An Act to amend the
environmental conservation law, in relation to banning formaldehyde
in certain children's products
• Bill to ban formaldehyde from children's products
41

42. New York Bill SB 497 on formamide in children’s
mats
• New York State's Senate Bill, SB 497, An Act to amend the
environmental conservation law, in relation to prohibiting the
manufacture, distribution and sale of children's foam mats
containing formamide
• Applies to "foam mat products" (mats, pads, mattresses and
cushions designed for use by children three years old/ younger,
including mats, pads, mattresses and cushions used as or in
connection with bedding, changing platforms, strollers and
carriages, high chairs, car seats, play pens and toys)
• Beginning 1 December 2019, no person, firm, partnership,
association, limited liability company, corporation shall sell/ offer for
sale any foam mat product containing formamide
42

43. New York Bill S 1454 regarding toxic chemicals in
children's products
• New York Senate Bill S 1454, Relates to regulation of toxic
chemicals in children's products
• Establish interstate chemical clearinghouse, provide greater
regulation of toxic chemicals in children's products
• Modeled after similar policies in Washington State, California and
Maine, with more comprehensive regulations for chemicals in
children's products rather than being on chemical-by-chemical basis
43

44. Vermont guidance on chemical disclosure for
children's products
• Vermont's Department of Health updated “Guide for Manufacturers”
and “Trade Secret Reporting Form” in connection with Chemical
Disclosure Law
• First reporting period began 1 January 2017
– Vermont's Department of Health released data submitted by 1 January
2017
– List of all reported products, brand name, manufacturer name, model
number available
• Next set of reports must be submitted by 31 August 2018, and
biennially thereafter
44

45. Washington State Children’s Safe Products
Reporting Rule update
• Washington Ecology updated its Children’s Safe Products Act
(CSPA) webpage
– Includes slides, Q&A and attendees list from its January 2017 public
stakeholder webinar on the proposed reporting rule
45

46. Washington State report on chemicals in children’s
products
• Non-Government Organization (NGO), Toxic-Free Future, analyzed
data reported to state of Washington under Children's Safe Products
Act (CSPA) and found that makers of kids’ products filed >5,300
reports showing products contain chemicals causing kids’ health
concerns
• Chemicals include:
– Toxic flame retardants reported by 16 companies
– Hormone-disrupting phthalates reported by 31 companies
– Cancer-causing formaldehyde, reported by 20 companies
• Most products reported are legal
• At least two manufacturers may be violating state and/or federal law
46

47. Suffolk County, New York, ‘Toxic Toys Act’ stayed
• Toy Industry Association (TIA) announced a stay of enforcement for
Suffolk County, New York’s Toxic Free Toys Act of 2015
– Pending court decision on lawsuit filed by Safe to Play Coalition
• Suit was filed to ensure county
– Adheres to federal, state requirements, exclusions and test methods;
– Only relies upon CPSC-accredited laboratories; and
– Will not pull safe, federally compliant toys & children’s products off store
shelves
• TIA members encouraged to contact TIA’s Owen Caine with
questions/ concerns
47

48. Iceland enacted regulation on chemicals in toys
• Iceland's Ministry of the Interior enacted Regulation 863/2016 to
amend Toy Safety Regulation 944/2014
• Changes particular substance limits in national Regulation
• In harmony with European Union's (EU) Toy Safety Directives,
2015/2115, 2015/2116 and 2015/2117
• Entered into force on 6 of October 2016
48

49. Turkey amends toy safety requirements to
harmonize with European Union
• Turkey published new regulations for toys, adopted from European
Union (EU), effective on April 4, 2017
• Important requirements include:
– New requirements for chemical properties, including restrictions on
chemicals classified as carcinogenic, mutagenic or reprotoxic (CMRs)
– Use of European (EN) standards for presumption of conformity
– EC declaration of conformity (DOC)
49

50. Brazil amends technical regulation for toys
• Brazil's National Institute of Metrology, Quality and Technology
(INMETRO) issued Ordinance No 563, 29 December 2016, to
approve Technical Regulation for Toys
• Clarifies existing requirements under Toys Regulations, including
chemical requirements, toxicological hazards and marking
requirements
50

51. Korean proposed revisions on safety of children’s
products
• Korean Agency for Technology and Standards (KATS) proposed
three children's products for safety confirmation
• Draft revisions for safety confirmation for children's products include:
– Toys:
• Addition of safety requirements for harmful chemicals and corresponding
change in testing methods; and
• Addition of microbiological safety toys
– “School things”: Reflection of revisions to toxic testing standard on
drugs, etc.
51

52. ASTM amends toy safety standard
• Updated standard to be published as ASTM F963:2016, Standard
Consumer Safety Specification for Toy Safety
• Updates include:
– Clarifications to requirements related to heavy elements in substrate
materials of toys;
– Addition of optional, alternate test method for total screen testing and
– Many other changes
52

53. Breast Cancer Fund report on kids' cosmetics
• NGO, Breast Cancer Fund's Campaign for Safe Cosmetics, issued
report on chemicals in children's cosmetics, Pretty Scary 2:
Unmasking toxic chemicals in kids’ makeup
• “[R]evealed the widespread presence of toxic chemicals in children's
shampoos, lip balms, makeup, nail products and face paints"
• Per NGO:
– Labels revealed hormone disrupting parabens, preservatives that
release formaldehyde;
– Laboratory testing unmasked lead (neurotoxicant), cadmium (hormone
disruptor) in face paints; and
– Laboratory testing revealed developmental toxicants like toluene and
possible carcinogens, such as ethylbenzene, vinyl acetate in fragranced
products
53

54. Teething products found to contain toxins
• American Chemical Society study, Migration of Parabens,
Bisphenols, Benzophenone-Type UV Filters, Triclosan, and
Triclocarban from Teethers and Its Implications for Infant Exposure
• Found some teething products contain bisphenol-A (BPA),
parabens, antimicrobials
• Substances restricted/ banned in US from personal care products,
plastics
54

55. Maryland Bill H.B. 206, on child care products
flame-retardants
• Maryland House Bill 206, An Act concerning Public Health – Child
Care Products Containing Flame–Retardant Chemicals – Prohibition
• Would prohibit importation/ sale of child care articles, furniture
containing flame-retardant chemicals
• Would take effect 1 October 2017
55

56. Maine proposes flame retardants as Priority
Chemicals
• Maine Department of Environmental Protection proposed routine
technical rule to designate two chemicals of high concern as priority
chemicals and require reporting for certain product categories
containing one/ more regulated chemicals
• Applies to manufacturers of specified product categories containing
intentionally added decabromodiphenyl ether (decaBDE) or
hexabromocylododecane (HBCD)
• Would clarify prevalence of such uses of listed flame retardants
• Specified categories include: Electronic devices with displays,
children's products, textiles and furnishings
56

57. Duke University flame retardant report
• Dr. Heather Stapleton and researchers at Duke University collected
1,141 samples of foam from upholstered furniture, car seats,
mattress pads and other children's products
• Found flame retardants in 68% purchased between 2005 and 2013
• Only 38% of items bought after 2014 contained flame retardants
57

58. US final rule on formaldehyde in composite wood
• Environmental Protection Agency (EPA) implementing final rule,
setting forth Formaldehyde Standards for Composite Wood Products
Act, adding Title VI to Toxic Substances Control Act (TSCA)
• Reduce formaldehyde emissions from composite wood products
58

59. New Chinese ‘environmental labeling’ of textiles
• Chinese Ministry of Environmental Protection (MEP) issued new
standard, HJ 2564:2016, Technical Requirements for Environmental
Labelling of Textile Products
• Implements Chinese Environmental Protection Law, aims to
minimize potential environmental and health effects of textile
products
• Sets out requirements for hazardous substances used in
manufacture of textile products
• Sets out various terminology & definitions, general principles, testing
methods, technical content
• Material used for packaging should be recyclable, degradable
• Entered into force 1 January 2017
59

60. South Korea draft revision of children’s products
safety standards
• Korean Agency for Technology and Standards (KATS) notified that
draft revisions of safety standards for children’s products have been
revised
• Revisions include:
– Addition of safety requirements of harmful chemicals (formaldehyde,
aryl amine) for textile products without separate standards;
– Addition of electrical safety requirements for textile products for infants
including Li-ion batteries and safety requirement for nonylphenol and
nonylphenol ethoxylate;
– Addition of safety requirements for harmful chemicals and
corresponding change in testing methods and
– Addition of microbiological safety requirements for toys
60

61. Sustainability Accounting Standards Board
proposes sustainability reporting requirements
• American Apparel & Footwear Association (AAFA) reports that
Sustainability Accounting Standards Board (SASB) is developing
industry-specific sustainability accounting standards designed for
disclosure of material sustainability information in mandatory
Securities and Exchange Commission (SEC) filings
• Standard allows for comparability and benchmarking between
industry peers
• Disclosure topics include: Management of Chemicals in Products;
Raw Materials Sourcing and Innovation; Labor Conditions and
Environmental Impacts in Supply Chain
61

62. Microfibers may cause water pollution
• Patagonia commissioned a study which found 98% of plastics
collected from 29 Great Lakes tributaries were microplastics
• Microfibers made up 71% of microplastics found
• Possible that miniscule pieces of plastic textiles laundered, released
from washing machines, eventually ending up in waterways
62

63. NGOs want nanomaterials regulated
• December 2016, several non-governmental organizations (NGOs)
released position paper regarding nanomaterials legislation, “Reset
governance: Nanomaterials as a case study on negligence”
• Calls for European Union (EU) to develop legislation to address
nanomaterials
• Specifically, those who signed ask for:
– Harmonized nanomaterials regulation in regards to human health,
environmental protection for all potential uses of nanomaterials;
– Include end-of-life management of nanomaterials;
– Mandatory labeling of products containing nanomaterials;
– Bio-monitoring of environment, public and workers and
– REACH registrations featuring nano-forms to be placed on Community
Rolling Action Plan (CoRAP) list for evaluation
63

64. Environmental Protection Agency’s first ten
chemicals for review per TSCA
• U.S. Environmental Protection Agency (EPA) announce first ten chemicals to be
evaluated under Toxic Substances Control Act (TSCA) reform:
– 1,4-Dioxane
– 1-Bromopropane
– Asbestos
– Carbon Tetrachloride
– Cyclic Aliphatic Bromide Cluster
– Methylene Chloride
– N-methylpyrrolidone
– Pigment Violet 29
– Tetrachloroethylene, also known as perchloroethylene
– Trichloroethylene
• Publication in Federal Register triggers statutory deadline to complete risk
evaluations within three years
• If EPA determines unreasonable risk, must mitigate risk within two years
• EPA must release scoping document within six months for each chemical
64

65. United States fast-tracks five chemicals per TSCA
• Environmental Protection Agency (EPA) requirements in Frank R.
Lautenberg Chemical Safety for the 21st Century Act
• Five chemicals to receive expedited action:
– Decabromodiphenyl ethers (DecaBDE) (flame retardant in textiles,
plastics & polyurethane foam);
– Hexachlorobutadiene (HCBD) (manufacture of rubber compounds &
lubricants & as solvent);
– Pentachlorothio-phenol (PCTP) (used as agent to make rubber more
pliable in industrial uses);
– Tris (4-isopropylphenyl) phosphate (used as flame retardant in
consumer products & other industrial uses); and
– 2,4,6-Tris(tert-butyl)phenol (used as fuel, oil, gasoline, lubricant
additive)
• Deadline for EPA to propose action 22 June 2019
65

66. European Member States to evaluate 117
substances 2017-2019
• European Chemicals Agency (ECHA) proposal to update Community
rolling action plan (CoRAP) for 2017-2019
• Member States planning to evaluate 117 substances (22 newly
selected)
• Final plan to be adopted March 2017
• Chemicals include, not limited to:
– Antimony;
– Butan-1-ol;
– Carbon black;
– Dioctyltin oxide;
– Dipotassium tetraborate;
– Potassium titanium oxide (K2Ti6O13);
– Titanium dioxide;
– Vinyl acetate;
– Xylene and
– Zinc oxide
66

67. Europe considers adding CMRs to REACH
• European Union (EU) notified of Draft Commission Regulation
amending Annex XVII to REACH as regards CMR substances
• Would include following substances: tetrahydro-2-furyl-methanol,
gallium arsenide, tributyltin compounds, [1,2-benzenedicarboxylic acid,
dihexyl ester, branched and linear], 1,2-dichloropropane, bisphenol A,
[phenol, dodecyl-, branched], [phenol, 2-dodecyl-, branched], [phenol,
3-dodecyl-, branched], [phenol, 4-dodecyl-, branched], [phenol,
(tetrapropenyl) derivatives], chlorophacinone (ISO), warfarin (ISO),
coumatetralyl (ISO), difenacoum (ISO), brodifacoum (ISO), flocoumafen
(ISO), disodium octaborate anhydrous, [e-glass microfibers of
representative composition], lead powder and lead massive,
bromadiolone (ISO), difethialone, [perfluorononan-1-oic acid, and its
sodium and ammonium salts], dicyclohexyl phthalate, 3,7-dimethylocta-
2,6-dienenitrile, triflumizole (ISO).
• Final date for comments: 21 February 2017
67

68. Europe updated harmonized standards per REACH
• Europe updated list of harmonized standards for jewelry and
eyeglasses in Annex XVII of REACH
• Three harmonized standards are now:
– EN 1811:2011+A1:2015, Reference test method for release of nickel
from all post assemblies which are inserted into pierced parts of the
human body and articles intended to come into direct and prolonged
contact with the skin
– EN 12472:2005+A1:2009, Method for the simulation of wear and
corrosion for the detection of nickel release from coated items
– EN 16128:2015, Ophthalmic optics — Reference method for the testing
of spectacle frames and sunglasses for nickel release
68

69. Commentary on China’s RoHS2 Catalogue
• Paul Goodman expert commentary on likely result of Chinese
Ministry of Industry and Information Technology’s (MIIT) China
RoHS2 standards working group meeting in November 2016
• Types of products that are being considered for first China RoHS2
catalogue are: Refrigerators; air-conditioners, extractor hoods,
washing machines, electric water heaters, gas water heaters,
printers, copy machines, fax machines, TVs, monitors,
microcomputers, mobile phones, phone sets
– Batteries in scope, removable batteries must be separately marked
• Goodman discusses labeling for China RoHS logo, “green e” logo
69

70. Taiwan draft revision RoHS
• Taiwan's Bureau of Standards, Metrology and Inspection (BSMI)
Draft Announcement, on issuance of new standards for mandatory
commodity inspection for 64 products, including: Air conditioning
equipment, appliances, dehumidifiers, electric blankets, fans,
electrical/ electronic equipment (EEE), electrical shavers, room air
cleaners / purifiers, toasters, vacuum cleaners, water heaters
• Certificate holders must clearly mark "presence of restricted
substance(s)" on product’s body, package, sticker or instruction
book
• Restricted substances: Lead, cadmium, mercury, hexavalent
chromium, PBDEs, PBBs
• Certificate holders must prove compliance with revised standards
before 31 December 2017
70

71. California notice of adoption on BPA warnings
• Office of Administrative Law approved rulemaking to replace its
emergency regulations requiring warnings for food packaging
containing bisphenol A (BPA)
• Maintains language from emergency regulation filed in April 2016,
with some changes and additions
• Regular rulemaking effective 1 January 2017
– Remains in effect until 30 December 2017, when businesses will need
to provide warnings pursuant to more general provisions of regulations
– Adds new subsection, requiring businesses that choose to provide safe
harbor point-of-sale warning for BPA exposures from canned/ bottled
foods to give Office of Environmental Health Hazard Assessment
(OEHHA) list of products covered by warning, where BPA intentionally
used in manufacture of can lining/ jar/ bottle seals
– OEHHA will post guidance on how to comply with new provisions
71

72. California BPA database posted
• New database available for public to determine whether bisphenol A
(BPA) intentionally used in manufacture of can, bottle cap, seal for
food/ beverage product
• Businesses subject to Proposition 65’s warning requirements
provided Office of Environmental Health Hazard Assessment
(OEHHA) with information for products covered by Proposition 65
warning for BPA in canned/ bottled foods, beverages, posted at
checkout stands in California
• List provides product names, descriptions, container sizes, Universal
Product Codes (UPCs)
72

73. Proposition 65 settlements
• Children's footwear: 0.1% by weight of DEHP and DBP
• Universal car mounts: 1,000 ppm of DEHP
• Craft wire: 100 ppm (0.01%) of lead
• Paper towel holders: 0.1% by weight of DEHP
• Hammers: 100 ppm of lead in their handgrips and/or accessible
surfaces
• SPF products:
– As of June 1, 2018, no more than 50 ppm benzophenone
– As of June 1, 2020, no more than 35 ppm benzophenone
73

74. C&R is your partner in global compliance
• 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: info@complianceandrisks.com
• W: www.complianceandrisks.com
74