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Chemicals Quarterly
Q3 2016
Presented by Stacey Bowers, MILS
26 October 2016
1
EPA’s ‘Quick Zccomplishments’ per TSCA
• In June 2016, President Obama enacted
the Frank R. Lautenberg Chemical
Safety for the 21st Century Act to
update the Toxic Substances Control
Act (TSCA)
• Since then, EPA has:
• Issued a plan outlining the first year of implementation;
• Completed first determinations on 7 premanufacture notices;
• Held public meetings on processes around fees and prioritization and evaluation
of chemicals;
• Prohibited 5 mercury compounds from export (1/1/20);
• Established a Science Advisory Committee on Chemicals (SACC) to provide
consultation on scientific, technical aspects on risk evaluations, methodologies,
pollution prevention measures/ approaches
2
EWG Suggests TSCA Chemicals
• In July 2016, Environmental Working Group (EWG) suggested several
chemicals for inclusion among the first 10 chemicals evaluated by the
EPA under the amended TSCA:
• Asbestos,
• Bisphenol A,
• Phthalates and
• Various flame retardants
• EPA’s list of 10 chemicals must be released by 22 December 2016
3
NGO Petitions Against Ortho-phthalates
• In May 2016 several NGOs filed a petition against ortho-phthalates as
food additives with the FDA
• Filed by organizations including:
• Breast Cancer Fund;
• Center for Environmental Health;
• Center for Food Safety;
• Earthjustice;
• Environmental Defense Fund and
• Learning Disabilities Association of America
• Before comment period closed, over 160K comments received
4
US Considers BPA in Food Contact Materials
• US federal House and Senate bills, H.R. 6269 and S.3412, Ban
Poisonous Additives Act of 2016
• Bisphenol A (BPA) treated as adulterating food/ beverages
• Food/ beverage containers composed of BPA, or that can release BPA, shall
be treated as containing poisonous/ deleterious substance which may render
contents injurious to health
• Apply to reusable food containers, food containers packed with food
5
US Issues Final Rule on GRAS
• US FDA issued a final rule “detailing the criteria for concluding that the
use of a substance in human or animal food is ‘generally recognized as
safe’ (GRAS)”
• GRAS substances do not require pre-market approval by FDA
• The Rule:
• Specifies “types of scientific evidence that can be used to demonstrate safety”
• Details a voluntary notification procedure; however, FDA encourages companies
to inform agency of GRAS conclusions to aid FDA’s food safety monitoring efforts
• The Rule became effective 17 October 2016
6
FDA perchlorate decision delayed
• Several NGOs petitioned FDA to ban potassium perchlorate and
sodium perchlorate monohydrate in food packaging
• Natural Resources Defense Council (NRDC),
• Center for Food Safety,
• Breast Cancer Fund and
• 3 more
• As FDA did not respond within the allotted time, the NGOs filed suit
for failing to act
• Joint motion to postpone final decision until March 2017
• Time to analyze data, literature; consult with experts
7
MERCOSUR Proposes Food Contact
Amendment
• MERCOSUR proposes to revise GMC Resolution No. 32/07, "Positive List
of Additives for Plastic Materials Intended for the Manufacture of
Packages and Equipment in Contact with Foods”
• Requires manufacturers, importers to know full composition of products
and make details available to customers, authorities
• Additional issues:
• How to define polymeric coatings;
• Whether or not revised list of additives should apply to polymeric coating used
in direct contact with food and
• Whether printing inks or ion exchange resins will be covered
• Final Resolution 03/13 expected in 2017
8
EU Parliament Prepares FCM Report
• European Parliament's (EP) Committee on Environment, Public
Health and Food Safety (ENVI) adopted a draft report
"Implementation of the FCMs Regulation ((EC) 1935/2004)"
• “[A]doption of specific EU measures for non-harmonised materials"
recommended, with FCMs constituting “a particular risk to human health”
given priority
• Additional improvements recommended for risk assessment; traceability;
enforcement and controls
• A vote is anticipated by EP October 2016
9
EC Amends Regulation on Food Contact
Plastics
• Commission Regulation (EU) 2016/1416 amends Regulation (EU) No
10/2011 on plastic FCMs
• Among the revisions:
• Establishes migration limits for heavy metals, including:
• Aluminum: 1 ppm
• Barium: 1 ppm
• Cobalt: 0.05 ppm
• Copper: 5 ppm
• Iron: 48 ppm
• Detection limit of 0.01 ppm, unless otherwise specified
• Plastic FCMs complying with Regulation (EU) No 10/2011 may be placed
on market until 14 September 2017 until sold
10
EC Works on Food Contact Materials
Legislation
• Experts are providing EU Commission with formal opinions to shape
food contact materials (FCMs) legislation
• Topics discussed include:
• Bisphenol A (BPA),
• Plastics recycling,
• Risk assessment of FCMs,
• Mineral oil hydrocarbons (MOHs) in FCMs and
• Migration in plastic baby bottles
11
EU Reference Laboratory Reports on FCMs
• European Commission’s (EC) Joint Research Centre’s (JRC) EU
Reference Laboratory for food contact materials (EURL-FCM) issued
its 2015 annual report of
• EURL-FCM’s work program “aims to contribute to a high level of health,
ensuring a high level of protection for consumers and the environment, while
favoring competitiveness and creation of jobs”
• EURL-FCM’s deliverables of 2015 include:
• Descriptions on identification of polymers in multilayer films in FCMs;
• Method to determine metals released from food contact plastics and
• National Reference Laboratory (NRL) expert events on ceramics, compliance
of kitchenware
12
Report on Paper & Board FCMs in EU
• Regulatory Toxicology and Pharmacology includes a report on the
establishment of an inventory list of chemicals used in printed paper
and board food contact materials (FCMs) and evaluation of migration
and toxicity properties of some of the included substances
• Printed paper and board are the second most commonly used FCMs
in Europe, superseded only by plastics
• Currently, no harmonized European Union (EU) regulation exists for
this type of FCMs
13
Lead, Cadmium Found in Czech Glassware
• Czech environmental organization, Arnika, analyzed lead in painted
drinking glasses
• Part of its “Let's Eat Toxics Free”
• Two-third of the glasses contained excess lead and
cadmium
• Lead exceeded REACH limit for articles that “may be
placed in the mouth by children” by 80x
• Arnika concluded continued use of heavy metals in painted FCMs is
“unfounded, and, in a sense, even unpardonable”
14
Italy Amends Decree on Food Contact
• Italy's Ministry of Health’s Ministerial Decree No. 142 amends the
1973 Decree on Hygienic Requirements for Packaging, Containers and
Utensils Intended to Come into Contact with Food
• Adds Articles 20 and 21, on regenerated cellulose films:
• Regenerated cellulose films may constitute or be part of finished product
• Identifies three categories of regenerated cellulose films:
• Uncoated regenerated cellulose film;
• Regenerated cellulose film with coating derived from cellulose and
• Regenerated cellulose film with coating consisting of plastics
• Currently in force
15
Montenegro Restricts Chinese Melamine
FCMs
• Order No. 1175, 2016 restricts polyamide, melamine food contact
materials from China and Hong Kong
• Aromatic amines from polyamide: 0.01 ppm
• Formaldehyde from melamine: 15 ppm
• Products can only be imported under certain conditions, including:
• Review of documentation;
• Physical examination of products and
• Sample testing of at least 10% of shipments
• In force since 7 September 2016
16
Food Packaging Forum Dossier on PFAS
• Food Packaging Forum (FPF) article on per- and polyfluoroalkyl
substances (PFASs), covering chemistry, application, regulation,
exposure and health effects of PFASs
• PFASs:
• Are used as surfactants, polymers, coatings and additives in FCMs
• Improve stain and grease repellence of FCM paper and board and non-stick
properties of cookware
• Have been found to be persistent and toxic
• FPF outlines global restrictions and prohibitions Persistent, toxic
17
Uzbekistan Draft Law on Food Safety
• Draft law on Food Safety would:
• Introduce the new term "sanitary and epidemiological
conclusion”
• Establish compliance requirements for food/ materials/
equipment in contact with food
• New document would take place of hygienic certificate
confirming compliance of food with requirements of
Food Safety Law
18
EU Proposes Amendments on Lead in Toys
• European Union notified WTO of Proposal to amend Annex II to
Directive 2009/48/EC on lead
• The proposal would further restrict lead in toys:
• In dry, brittle, powder-like, or pliable toy material: 2.0 ppm
• In liquid/ sticky toy material: 0.5 ppm
• In scraped-off toy material: 23 ppm
• Entry into force postponed to Q3 2018
19
Germany Amends Toy Safety Regulation
• Federal Law Gazette of Germany released Second Regulation
Amending Regulation on the Safety of Toys
• Amends Article 1 of Decree of October 2015
• Requires manufacturers to market toys with instructions, security in German
• Lead in toys must not exceed 0.7 micrograms
• Took effect 14 July 2016
20
EurAsEC Draft Amendment ‘On Safety of Toys’
• The Eurasian Economic Commission (EEC)
Customs Union notified the WTO of Draft
amendments No. 2 to Technical Regulations
of the Customs Union "On Safety of Toys"
(TR CU 008/2011)
• The Technical Regulation is based on the EU’s
Toy Safety Directive
• The Customs Union includes Armenia, Belarus,
Kazakhstan, Kyrgyz Republic and Russia
21
Israel Draft Law on Dangerous Toys
• Israel's Knesset issued a draft law to introduce
penal provisions concerning dangerous toys
• Characteristics of dangerous toys include
potential to cause irritation
• Consequence of possessing dangerous toys:
4 years in prison
• Consequence of producing, importing or selling:
3 years in prison
22
Philippines Bill on Chemicals in Children’s
Products
• Applies to children's toys, school supplies and childcare articles
• Philippines FDA to:
• Prepare list of chemicals in children's products which cause/ may cause
harm, injury or death to children;
• Identify banned/ prohibited chemicals and
• Specify limits for certain chemicals
• The proposed list of chemicals includes:
• Heavy metals,
• Phthalates and
• Bisphenol A (BPA)
23
CPSC Draft Notice on Phthalates
• US CPSC issued a Draft Notice of Proposed Rulemaking on specified
phthalates
• Specified plastics with specified additives would not require testing
for compliance with CPSIA phthalates restrictions
• Four plastics in question:
• Polypropylene (PP);
• Polyethylene (PE);
• High-impact polystyrene (HIPS) and
• Acrylonitrile butadiene styrene (ABS)
24
EC Draft Directive on BPA in toys
• European Commission is considering a Draft Commission Directive
amending Directive 2009/48/EC as regards bisphenol A (BPA)
• The Draft would reduce the migration limit for BPA in toys intended
for children under 3 years or in toys intended to be put in mouth:
• 0.04 mg/l (migration limit) in accordance with the methods laid down in EN
71-10:2005 and EN 71-11:2005
25
Children’s Exposure to Chemicals in the US
• Experts from Project Targeting Environmental Neuro-developmental
Risks (Tendr) penned statement calling for actions to eliminate, or
significantly reduce, exposures to chemicals
• Statement lists "prime examples" of chemicals that may affect brain
development, including:
• Organophosphate pesticides,
• PBDE flame retardants,
• Lead,
• Particulate air pollution and
• PCBs
• Regulators ask that businesses "eliminate neuro-developmental
toxicants from their supply chains and products"
26
Toxic Imitation Jewelry in Bangladesh
• Bangladesh's Environment and Social Development Organization
(ESDO) surveyed 67 jewelry items:
• 32 for adult
• 35 for children
• Most of the earrings contained arsenic and lead in high levels and
mercury in medium levels
• In Bangladesh, there are no regulations toxic substances in jewelry
27
CA Proposed Priority Products
• California's (DTSC) proposed to designate certain children’s foam-
padded sleeping products as “Priority Products” under Safer
Consumer Product Regulations (SCPR)
• Nap mats, soft-sided portable cribs, play pens, infant travel beds, bassinets,
portable infant sleepers, bedside sleepers, infant sleep positioners, co-
sleepers and baby/ toddler foam pillows
• Designates TDCPP, TCEP as Chemicals of Concern
• Public comments were accepted through the end of August
• DTSC will hold a public hearing soon
28
MN Amends Chemicals of High Concern List
• Minnesota (MN) Department of Public Health (DPH) updated
Chemicals of High Concern (CHC) list
• Changed “High Production Volume” (HPV) status of certain chemicals;
• Added 66 chemicals to CHC list and
• Removed 28 chemicals from CHC list
• DPH will consider tris (1, 3-dichloro-2-propyl) phosphate (TDCPP),
chemical group of nonylphenols, its ethoxylates as candidate
chemicals
29
OR Proposed Rule on High Priority Chemicals
in Children’s Products
• As part of its Toxic Free Kids Act, the Oregon Health Authority
proposed a rule on Manufacturer Disclosure of High Priority
Chemicals of Concern in Children’s Products
• Specifies Practical Quantification Limit (PQL) for intentionally-added
chemicals
• Establishes manufacturers' disclosure and reporting requirements
• If passed, first reports due 1 January 2018 for products sold in 2017,
containing HPCCH above PQL
• Manufacturers of children’s products with annual worldwide gross
sales of less than $5 million exempt from disclosure requirements
30
Reminder on VT Chemical Reporting
Requirements
• Toy Industry Association (TIA) reminder: chemical reporting for
children’s products sold in Vermont (VT) required beginning 1
January 2017
• Companies must use VT Department of Health’s online reporting
system to notify VT when products contain one/ more chemicals of
high concern to children
• Chemicals may be intentionally added to serve particular function; or
• May be present as contaminants
• TIA to host webinar November 9 to help members, stakeholders
learn to use online tool
31
WA State Considers Chemicals of High
Concern to Children
• Washington State is considering adding phthalates, flame retardants,
perfluorinated chemicals to CHCC list:
• Phthalates DNPP, DEMP, DIBP, DCHP, DIOP;
• Flame retardants DBDPE, dechlorane plus, BTBPE, TCP, SCPP and
• PFOA-related substances
• Chemicals in children’s cosmetics are particularly under the
microscope:
• Personal Care Products Council (PCPC) requested WA Department of Ecology
consider removing certain parabens
• American Chemistry Council (ACC) requested delisting phthalic anhydride
(aids in production of plasticizers)
• Ecology not considering ACC requests to delist formaldehyde or
octamethylcyclotetrasiloxane (D4)
32
WA State Updates Reporting Rule
• Washington State Ecology updated its Children’s Safe Products –
Reporting Rule
• House Bill (HB) 2545 passed, identified 6 flame retardants to be
considered for inclusion on Chemicals of High Concern to Children
(CHCC) list:
• Triphenyl phosphate (TPP);
• Tris (1-chloro-2-propyl) phosphate (TCPP);
• Bis (2-ethylhexyl)-2,3,4,5-tetrabromophthalate (TBPH);
• (2-ethylhexyl)-2,3,4,5-tetrabromobenzoate (TBB);
• Isopropylated triphenyl phosphate (IPTPP); and
• Bis(chloromethyl) propane-1,3-diyltetrakis (2-chloroethyl) bisphosphate (V6)
• These 6 will be evaluated against CHCC criteria, may be added to CHCC
list
33
Wal-Mart Requests Removal of Chemicals
• Wal-Mart asking suppliers to remove formaldehyde, triclosan and 6
other substances from products
• Per Wal-Mart, manufacturers must list targeted ingredients on
packaging by 2018 and work to find alternatives
• Affects ~90,000 items made by 700 manufacturers
• So far, suppliers removed 95% of chemicals on list of products sold in U.S.
• Chemicals on list include:
• Toluene (used in paint thinners, nail polish, fragrances)
• Diethyl phthalate (plasticizer in cosmetics, insecticides, aspirin)
• NPE (surfactants in industrial applications, products like laundry detergent)
• Butylparabens (preservative in cosmetics)
• Propylparaben (preservative)
34
US Rule on Triclosan & Triclocarbon
• US FDA issued a final rule on safety and effectiveness of antibacterial
soaps
• FDA removed triclosan, triclocarbon from OTC hand and body washes
• The final rule applies to consumer antiseptic wash products intended for use
with water and rinsed off after use.
35
US Bills on Endocrine-disrupting Chemicals
• Senator Dianne Feinstein (D-CA) introduced two bills concerning
endocrine-disrupting chemicals (EDCs)
• Personal Care Products Safety Act
• BPA in Food Packaging Right to Know Act
• Feinstein compares European Union's regulation
of EDCs to US legislation
• To "address the health effects caused by endocrine-disrupting
chemicals through updated federal safety oversight"
36
Danish Retailer to Eliminate Toxins
• Danish retailer, Coop, plans to phase out 12 substances/groups of chemicals
from private label products by end of 2017
• “Dirty dozen” includes:
• Bisphenol A (BPA);
• Fluorinated compounds;
• Pesticides;
• PVC and phthalates;
• Chemicals in textiles;
• Substances identified as SVHCs;
• Allergenic scented substances, preservatives;
• Tricoslan and
• Preservative methylisothiazolinone (MI)
• Has stopped selling some products, such as Colgate Total toothpaste, which
contains triclosan, Huggies baby wipes, which contain MI
37
Europe Amends REACH Skin Sensitivity
Testing
• European Commission (EC) Commission Regulation (EU) 2016/1688
amending Annex VII to REACH as regards skin sensitisation
• Alternative in chemico / in vitro test methods for skin sensitization
• Test methods may allow assessment of skin sensitisation without need for in
vivo testing
• Goal to reduce animal testing
38
Philippines Circular on Zinc Oxide
• Philippines Food and Drug Administration (FDA) Circular No. 2016-
009, Reiteration on the Classification of Diaper Rash Creams/
Lotions/Ointments/Powders and Other Products Containing Zinc
Oxide
• Diaper rash creams, ointments, etc., containing zinc oxide may be
considered cosmetics or drugs, dependent upon claims to prevent or
treat disease
• FDA recommends manufacturers, distributors, importers, sellers
secure authorizations prior to sale
39
EPA Issues National Rule on Formaldehyde
• US EPA issued a final rule regarding exposure to formaldehyde from
wood products
• Products include: hardwood plywood; medium-density fiberboard;
particleboard; household, other finished goods containing these products
• Testing requirements to ensure compliance
• Requirements for labeling, recordkeeping and enforcement provisions
• Rule is based on California Air Resources Board (ARB) regulation
• Takes force in one year
40
Turkey Notification on Hazardous Substances
• Turkey's Ministry of Economy enacted Notification Number: 29699 on
Control of Import Inspection & Notification of Some Consumer
Products (Product Safety & Inspection: 2016/25)
• Consumer products, test parameters listed, including:
• Art materials: To be tested for azo dyes, heavy metals, phthalates
• Gloves: To be tested for cadmium, dioctyltin
• Jewelry: To be tested for cadmium, nickel
• Phone cases: To be tested for azo dyes, cadmium
• Sanitary products: To be tested for azo dyes, dioctyltin
• Watches: To be tested for azo dyes, cadmium, nickel
41
Vietnam Guidance on Azo Dyes &
Formaldehyde
• Vietnam's Ministry of Industry and Trade reminds industry that
textiles products are subject to Circular No. 37/2015/TT-BCT starting
1 July 2016
• Azo dyes: 30 ppm
• Formaldehyde:
• Textile products for children under 36 months of age: 30 ppm
• Textile products in direct contact with skin: 75 ppm
• Textile products without direct contact with skin: 300 ppm
42
Indonesia Regulation on Hazardous
Substances in Baby Clothes
• Indonesia enacted No. 47 / M-IND / PER / 7/2016, on azo dyes,
formaldehyde and heavy metals from the fabrics used for baby
clothes
• Establishes conformity assessment procedures to ensure compliance
with Indonesian restrictions on azodyes, formaldehyde and heavy
metals in fabrics for baby clothes
43
REACH Footwear Guideline Updated
• PD CEN/TR 16417:2016, Footwear Industry Guideline for Substances
of Very High Concern (Annex XIV of REACH), Standard
• Supersedes PD CEN/TR 16417:2012
• Provides guidelines on usage, presence of substances of very high concern
(SVHC), apply to footwear
44
European Union Decision on Footwear
Ecolabel
• Establishing the Ecological Criteria for the Award of the European
Union (EU) Ecolabel for Footwear, Decision No. 1349/2016/EU
• Criteria for awarding EU Ecolabel to footwear includes:
• Volatile organic compounds (VOCs);
• Hazardous substances in product/ components and
• Restricted Substances List (RSL)
45
EU Considers Restrictions on CMRs in Textiles
• EC proposed fast-track restriction of 286 carcinogenic, mutagenic,
reprotoxic (CMR) substances in textiles in two phases
• First phase scope limited to articles coming into direct contact with skin
• Wider scope to be considered in second phase, may include:
• Floor coverings;
• Carpets;
• Upholstery;
• Clothing accessories and
• Leather articles
• REACH Committee determines which substances to
restrict
46
Eurasian Economic Commission Proposes
Regulation of Textiles
• Customs Union seeks to clarify, simplify textiles, light industry goods
certifications, conformity assessment procedures
• New standards set for substances in textiles, light industry products made of
polyvinyl chloride (PVC), polyurethane
• Cadmium;
• Chloroethyl;
• Toluene diisocyanate and
• Zinc
• Migration controls of substances from inner surface of footwear
• Effective one year after each member country signs
• Once in place manufacturers only need to declare if articles contain
harmful substances
47
China National Standard for Juvenile Textiles
• SAC implemented GB 31701-2015, Safety Technical Code for Infants’
and Children’s Textile Products
• Limits on 6 plasticizers, lead and cadmium
• Implemented 1 June 2016
• 2-year transition period for compliance
48
Canada Nanotechnology Bill
• Canada House of Commons first reading of Act to amend the
Canadian Environmental Protection Act, 1999 (CEPA)
(nanotechnology) (C-287)
• Would implement investigation, assessment procedures of nanomaterials
• Mandates risk assessment process to identify potential benefits, risks of
nanotechnologies before nanoproducts enter market
• Create national inventory regarding nanotechnology, using information
collected under CEPA and “any other information to which the Ministers have
access”
49
US Reports on Conflict Minerals
• More than 1,200 companies filed conflict mineral reports due to U.S.
Securities and Exchange Commission by June 2016
• More than 70% unable to determine results
• U.S.-listed companies required to investigate supply chain for tin,
tantalum, tungsten, gold, under 2010 Dodd-Frank Act rule, meant to
stop mining revenue to militia groups in Democratic Republic of the
Congo, adjacent countries
• UN says rebels still profiting, despite laws
50
US Bill on Conflict Materials
• United States (US) House Financial Services Committee amended bill
to repeal US's conflict minerals reporting rule, HR 5983, Financial
CHOICE [Creating hope and opportunity for investors, consumers and
entrepreneurs] Act
• Would repeal section requiring due diligence, reporting on whether
sourcing of conflict minerals supports armed groups in Democratic
Republic of Congo (DRC), or neighboring countries
51
Denmark Flame Retardant Categories
• Danish Environmental Protection Agency (MST) issued a Category
approach for selected brominated flame retardants
• Grouped BFRs found in 2014 MST survey on 67 brominated flame retardants
• (Q)SAR predictions of environmental, health effects within initial groups
generated, investigated
• 61 BFRs need further investigation
• Aim is to address groups of BFRs in regulations
52
Canada amends Prohibition Regulations
• Prohibition Regulations, 2012, amended to prohibit:
• Hexabromocyclododecane (HBCD);
• Perfluorooctanoic acid, salts, precursors (PFOA);
• Long-chain perfluorocarboxylic acids, salts, precursors (LC-PFCAs);
• Polybrominated diphenyl ethers (PBDEs) and
• Perfluorooctane sulfonate, salts, precursors (PFOS)
• Permitted uses include:
• Adhesives and coatings for aircraft refinishing and
• Semiconductor manufacturing process
53
Eurasian Economic Commission Proposes
RoHS-like Legislation
• Eurasian Economic Commission (EEC) approved draft technical
regulations of Eurasian Economic Union (EAEC) "On Restrictions on
the Use of Hazardous Substances in electrical and electronics
products“
• Would restrict lead, mercury, cadmium, hexavalent chromium,
polybrominated biphenyls, PBDEs in EEE
• In alignment with international practice, including EU’s RoHS 2
• Will be considered November 2016
54
Singapore Enacts RoHS Legislation
• Singapore Ministry of the Environment and Water Resources approved
Order 263/2016
• Adds restrictions for six hazardous substances in electrical and electronic
equipment:
• Cadmium (0.01%)
• Hexavalent Chromium (0.1%)
• Lead (0.1%)
• Mercury (0.1%)
• Polybrominated biphenyls (PBB) (0.1%)
• Polybrominated diphenyl ethers (PBDE) (0.1%)
• Products covered: Mobile phones, laptops, refrigerators, air conditioners,
televisions, washing machines
• Batteries, products designed for industrial use excluded
• Enters force 1 June 2017
55
New Zealand Bans Products Containing
Asbestos
• New Zealand Environment Minister prohibited the import of
products containing asbestos
• Inventory from 2014 shows asbestos no longer imported for use in buildings
or where public exposure likely; still imported for specialist products, such as
gaskets, seals and brake linings
• Permits issued if no alternative product available/if alternative
disproportionately expensive, in which case, importer must show risk of
asbestos exposure can be safely managed
• Effective 1 October 2016
56
New Zealand Proposes POPs Legislation
• New Zealand Environmental Protection Authority (EPA) proposed
legislation to comply with international obligations regarding
Persistent Organic Pollutants (POPs)
• Would ensure compliance with Stockholm, Rotterdam Conventions
• All but two of proposed additions to POPs list no longer in New
Zealand, not approved under legislation, or being phased out
• Submissions close 27 October 2016
57
Commentary on Ecuador Battery Regulation
• Ecuador’s Ministry of Industry and Productivity (MIPRO) approved
Resolution 16227, First Revision of Ecuadorian Technical Regulation
(RTE) 105 on batteries
• Content limits of 0.0005% mercury, 0.002% cadmium by weight remain
• RTE 105 (R):
• Provides more options for meeting product requirements;
• Adds more options for test methods to prove conformity and
• Adds more documentation for certification
• Takes effect 28 December 2016
58
CA Adopts Prop 65 rule on ‘Clear &
Reasonable Warnings’
• CA OAL approved adoption of amendments to “ Clear and
Reasonable Warnings” for Proposition 65
• Clear, reasonable warning requirements; general provisions
• Interested parties may request lead agency adopt specific product, chemical,
or area exposure warning, or may request guidance from lead agency
• Stakeholders not required to provide separate warnings to each exposed
individual
• Party to court-ordered settlement/ final judgment deemed to be providing
“clear and reasonable” warning if compliant with order/ judgment
• Operative 30 August 2018; in interim, businesses may comply with
current or new regulation
59
CA BPA Emergency Regulation Extended
• California's OAL extended the emergency regulations on Proposition
65 warnings for bisphenol A (BPA) in canned, bottled food, drink by
90 days
• Takes effect 17 October 2016
60
Recent CA Prop 65 Settlements
• Audio listening devices: 1,000 ppm di(2-ethylhexyl) phthalate (DEHP)
• USB cords: 1,000 ppm of diisononyl phthalate (DINP)
• Vinyl Zippered Mattress Protectors: 1,000 ppm of DEHP
• Strainers: 1,000 ppm of DEHP and di-n-butyl phthalate (DBP)
• Exercise mats: 1,000 ppm of DINP and DEHP
61
Recent Prop 65 Chemical Listings
• Chemicals listed in Q3 to cause cancer are:
• Bromodichloroacetic acid (CAS No. 71133-14-7)
• 1-bromopropane (CAS No. 106-94-5)
• Furfuryl alcohol (CAS No. 98-00-0)
• Office of Environmental Health Hazard Assessment (OEHHA) intends
to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate
(PFOS) as known to cause reproductive toxicity
62
63
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EPA's Quick Accomplishments Under Amended TSCA

  • 1. Chemicals Quarterly Q3 2016 Presented by Stacey Bowers, MILS 26 October 2016 1
  • 2. EPA’s ‘Quick Zccomplishments’ per TSCA • In June 2016, President Obama enacted the Frank R. Lautenberg Chemical Safety for the 21st Century Act to update the Toxic Substances Control Act (TSCA) • Since then, EPA has: • Issued a plan outlining the first year of implementation; • Completed first determinations on 7 premanufacture notices; • Held public meetings on processes around fees and prioritization and evaluation of chemicals; • Prohibited 5 mercury compounds from export (1/1/20); • Established a Science Advisory Committee on Chemicals (SACC) to provide consultation on scientific, technical aspects on risk evaluations, methodologies, pollution prevention measures/ approaches 2
  • 3. EWG Suggests TSCA Chemicals • In July 2016, Environmental Working Group (EWG) suggested several chemicals for inclusion among the first 10 chemicals evaluated by the EPA under the amended TSCA: • Asbestos, • Bisphenol A, • Phthalates and • Various flame retardants • EPA’s list of 10 chemicals must be released by 22 December 2016 3
  • 4. NGO Petitions Against Ortho-phthalates • In May 2016 several NGOs filed a petition against ortho-phthalates as food additives with the FDA • Filed by organizations including: • Breast Cancer Fund; • Center for Environmental Health; • Center for Food Safety; • Earthjustice; • Environmental Defense Fund and • Learning Disabilities Association of America • Before comment period closed, over 160K comments received 4
  • 5. US Considers BPA in Food Contact Materials • US federal House and Senate bills, H.R. 6269 and S.3412, Ban Poisonous Additives Act of 2016 • Bisphenol A (BPA) treated as adulterating food/ beverages • Food/ beverage containers composed of BPA, or that can release BPA, shall be treated as containing poisonous/ deleterious substance which may render contents injurious to health • Apply to reusable food containers, food containers packed with food 5
  • 6. US Issues Final Rule on GRAS • US FDA issued a final rule “detailing the criteria for concluding that the use of a substance in human or animal food is ‘generally recognized as safe’ (GRAS)” • GRAS substances do not require pre-market approval by FDA • The Rule: • Specifies “types of scientific evidence that can be used to demonstrate safety” • Details a voluntary notification procedure; however, FDA encourages companies to inform agency of GRAS conclusions to aid FDA’s food safety monitoring efforts • The Rule became effective 17 October 2016 6
  • 7. FDA perchlorate decision delayed • Several NGOs petitioned FDA to ban potassium perchlorate and sodium perchlorate monohydrate in food packaging • Natural Resources Defense Council (NRDC), • Center for Food Safety, • Breast Cancer Fund and • 3 more • As FDA did not respond within the allotted time, the NGOs filed suit for failing to act • Joint motion to postpone final decision until March 2017 • Time to analyze data, literature; consult with experts 7
  • 8. MERCOSUR Proposes Food Contact Amendment • MERCOSUR proposes to revise GMC Resolution No. 32/07, "Positive List of Additives for Plastic Materials Intended for the Manufacture of Packages and Equipment in Contact with Foods” • Requires manufacturers, importers to know full composition of products and make details available to customers, authorities • Additional issues: • How to define polymeric coatings; • Whether or not revised list of additives should apply to polymeric coating used in direct contact with food and • Whether printing inks or ion exchange resins will be covered • Final Resolution 03/13 expected in 2017 8
  • 9. EU Parliament Prepares FCM Report • European Parliament's (EP) Committee on Environment, Public Health and Food Safety (ENVI) adopted a draft report "Implementation of the FCMs Regulation ((EC) 1935/2004)" • “[A]doption of specific EU measures for non-harmonised materials" recommended, with FCMs constituting “a particular risk to human health” given priority • Additional improvements recommended for risk assessment; traceability; enforcement and controls • A vote is anticipated by EP October 2016 9
  • 10. EC Amends Regulation on Food Contact Plastics • Commission Regulation (EU) 2016/1416 amends Regulation (EU) No 10/2011 on plastic FCMs • Among the revisions: • Establishes migration limits for heavy metals, including: • Aluminum: 1 ppm • Barium: 1 ppm • Cobalt: 0.05 ppm • Copper: 5 ppm • Iron: 48 ppm • Detection limit of 0.01 ppm, unless otherwise specified • Plastic FCMs complying with Regulation (EU) No 10/2011 may be placed on market until 14 September 2017 until sold 10
  • 11. EC Works on Food Contact Materials Legislation • Experts are providing EU Commission with formal opinions to shape food contact materials (FCMs) legislation • Topics discussed include: • Bisphenol A (BPA), • Plastics recycling, • Risk assessment of FCMs, • Mineral oil hydrocarbons (MOHs) in FCMs and • Migration in plastic baby bottles 11
  • 12. EU Reference Laboratory Reports on FCMs • European Commission’s (EC) Joint Research Centre’s (JRC) EU Reference Laboratory for food contact materials (EURL-FCM) issued its 2015 annual report of • EURL-FCM’s work program “aims to contribute to a high level of health, ensuring a high level of protection for consumers and the environment, while favoring competitiveness and creation of jobs” • EURL-FCM’s deliverables of 2015 include: • Descriptions on identification of polymers in multilayer films in FCMs; • Method to determine metals released from food contact plastics and • National Reference Laboratory (NRL) expert events on ceramics, compliance of kitchenware 12
  • 13. Report on Paper & Board FCMs in EU • Regulatory Toxicology and Pharmacology includes a report on the establishment of an inventory list of chemicals used in printed paper and board food contact materials (FCMs) and evaluation of migration and toxicity properties of some of the included substances • Printed paper and board are the second most commonly used FCMs in Europe, superseded only by plastics • Currently, no harmonized European Union (EU) regulation exists for this type of FCMs 13
  • 14. Lead, Cadmium Found in Czech Glassware • Czech environmental organization, Arnika, analyzed lead in painted drinking glasses • Part of its “Let's Eat Toxics Free” • Two-third of the glasses contained excess lead and cadmium • Lead exceeded REACH limit for articles that “may be placed in the mouth by children” by 80x • Arnika concluded continued use of heavy metals in painted FCMs is “unfounded, and, in a sense, even unpardonable” 14
  • 15. Italy Amends Decree on Food Contact • Italy's Ministry of Health’s Ministerial Decree No. 142 amends the 1973 Decree on Hygienic Requirements for Packaging, Containers and Utensils Intended to Come into Contact with Food • Adds Articles 20 and 21, on regenerated cellulose films: • Regenerated cellulose films may constitute or be part of finished product • Identifies three categories of regenerated cellulose films: • Uncoated regenerated cellulose film; • Regenerated cellulose film with coating derived from cellulose and • Regenerated cellulose film with coating consisting of plastics • Currently in force 15
  • 16. Montenegro Restricts Chinese Melamine FCMs • Order No. 1175, 2016 restricts polyamide, melamine food contact materials from China and Hong Kong • Aromatic amines from polyamide: 0.01 ppm • Formaldehyde from melamine: 15 ppm • Products can only be imported under certain conditions, including: • Review of documentation; • Physical examination of products and • Sample testing of at least 10% of shipments • In force since 7 September 2016 16
  • 17. Food Packaging Forum Dossier on PFAS • Food Packaging Forum (FPF) article on per- and polyfluoroalkyl substances (PFASs), covering chemistry, application, regulation, exposure and health effects of PFASs • PFASs: • Are used as surfactants, polymers, coatings and additives in FCMs • Improve stain and grease repellence of FCM paper and board and non-stick properties of cookware • Have been found to be persistent and toxic • FPF outlines global restrictions and prohibitions Persistent, toxic 17
  • 18. Uzbekistan Draft Law on Food Safety • Draft law on Food Safety would: • Introduce the new term "sanitary and epidemiological conclusion” • Establish compliance requirements for food/ materials/ equipment in contact with food • New document would take place of hygienic certificate confirming compliance of food with requirements of Food Safety Law 18
  • 19. EU Proposes Amendments on Lead in Toys • European Union notified WTO of Proposal to amend Annex II to Directive 2009/48/EC on lead • The proposal would further restrict lead in toys: • In dry, brittle, powder-like, or pliable toy material: 2.0 ppm • In liquid/ sticky toy material: 0.5 ppm • In scraped-off toy material: 23 ppm • Entry into force postponed to Q3 2018 19
  • 20. Germany Amends Toy Safety Regulation • Federal Law Gazette of Germany released Second Regulation Amending Regulation on the Safety of Toys • Amends Article 1 of Decree of October 2015 • Requires manufacturers to market toys with instructions, security in German • Lead in toys must not exceed 0.7 micrograms • Took effect 14 July 2016 20
  • 21. EurAsEC Draft Amendment ‘On Safety of Toys’ • The Eurasian Economic Commission (EEC) Customs Union notified the WTO of Draft amendments No. 2 to Technical Regulations of the Customs Union "On Safety of Toys" (TR CU 008/2011) • The Technical Regulation is based on the EU’s Toy Safety Directive • The Customs Union includes Armenia, Belarus, Kazakhstan, Kyrgyz Republic and Russia 21
  • 22. Israel Draft Law on Dangerous Toys • Israel's Knesset issued a draft law to introduce penal provisions concerning dangerous toys • Characteristics of dangerous toys include potential to cause irritation • Consequence of possessing dangerous toys: 4 years in prison • Consequence of producing, importing or selling: 3 years in prison 22
  • 23. Philippines Bill on Chemicals in Children’s Products • Applies to children's toys, school supplies and childcare articles • Philippines FDA to: • Prepare list of chemicals in children's products which cause/ may cause harm, injury or death to children; • Identify banned/ prohibited chemicals and • Specify limits for certain chemicals • The proposed list of chemicals includes: • Heavy metals, • Phthalates and • Bisphenol A (BPA) 23
  • 24. CPSC Draft Notice on Phthalates • US CPSC issued a Draft Notice of Proposed Rulemaking on specified phthalates • Specified plastics with specified additives would not require testing for compliance with CPSIA phthalates restrictions • Four plastics in question: • Polypropylene (PP); • Polyethylene (PE); • High-impact polystyrene (HIPS) and • Acrylonitrile butadiene styrene (ABS) 24
  • 25. EC Draft Directive on BPA in toys • European Commission is considering a Draft Commission Directive amending Directive 2009/48/EC as regards bisphenol A (BPA) • The Draft would reduce the migration limit for BPA in toys intended for children under 3 years or in toys intended to be put in mouth: • 0.04 mg/l (migration limit) in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005 25
  • 26. Children’s Exposure to Chemicals in the US • Experts from Project Targeting Environmental Neuro-developmental Risks (Tendr) penned statement calling for actions to eliminate, or significantly reduce, exposures to chemicals • Statement lists "prime examples" of chemicals that may affect brain development, including: • Organophosphate pesticides, • PBDE flame retardants, • Lead, • Particulate air pollution and • PCBs • Regulators ask that businesses "eliminate neuro-developmental toxicants from their supply chains and products" 26
  • 27. Toxic Imitation Jewelry in Bangladesh • Bangladesh's Environment and Social Development Organization (ESDO) surveyed 67 jewelry items: • 32 for adult • 35 for children • Most of the earrings contained arsenic and lead in high levels and mercury in medium levels • In Bangladesh, there are no regulations toxic substances in jewelry 27
  • 28. CA Proposed Priority Products • California's (DTSC) proposed to designate certain children’s foam- padded sleeping products as “Priority Products” under Safer Consumer Product Regulations (SCPR) • Nap mats, soft-sided portable cribs, play pens, infant travel beds, bassinets, portable infant sleepers, bedside sleepers, infant sleep positioners, co- sleepers and baby/ toddler foam pillows • Designates TDCPP, TCEP as Chemicals of Concern • Public comments were accepted through the end of August • DTSC will hold a public hearing soon 28
  • 29. MN Amends Chemicals of High Concern List • Minnesota (MN) Department of Public Health (DPH) updated Chemicals of High Concern (CHC) list • Changed “High Production Volume” (HPV) status of certain chemicals; • Added 66 chemicals to CHC list and • Removed 28 chemicals from CHC list • DPH will consider tris (1, 3-dichloro-2-propyl) phosphate (TDCPP), chemical group of nonylphenols, its ethoxylates as candidate chemicals 29
  • 30. OR Proposed Rule on High Priority Chemicals in Children’s Products • As part of its Toxic Free Kids Act, the Oregon Health Authority proposed a rule on Manufacturer Disclosure of High Priority Chemicals of Concern in Children’s Products • Specifies Practical Quantification Limit (PQL) for intentionally-added chemicals • Establishes manufacturers' disclosure and reporting requirements • If passed, first reports due 1 January 2018 for products sold in 2017, containing HPCCH above PQL • Manufacturers of children’s products with annual worldwide gross sales of less than $5 million exempt from disclosure requirements 30
  • 31. Reminder on VT Chemical Reporting Requirements • Toy Industry Association (TIA) reminder: chemical reporting for children’s products sold in Vermont (VT) required beginning 1 January 2017 • Companies must use VT Department of Health’s online reporting system to notify VT when products contain one/ more chemicals of high concern to children • Chemicals may be intentionally added to serve particular function; or • May be present as contaminants • TIA to host webinar November 9 to help members, stakeholders learn to use online tool 31
  • 32. WA State Considers Chemicals of High Concern to Children • Washington State is considering adding phthalates, flame retardants, perfluorinated chemicals to CHCC list: • Phthalates DNPP, DEMP, DIBP, DCHP, DIOP; • Flame retardants DBDPE, dechlorane plus, BTBPE, TCP, SCPP and • PFOA-related substances • Chemicals in children’s cosmetics are particularly under the microscope: • Personal Care Products Council (PCPC) requested WA Department of Ecology consider removing certain parabens • American Chemistry Council (ACC) requested delisting phthalic anhydride (aids in production of plasticizers) • Ecology not considering ACC requests to delist formaldehyde or octamethylcyclotetrasiloxane (D4) 32
  • 33. WA State Updates Reporting Rule • Washington State Ecology updated its Children’s Safe Products – Reporting Rule • House Bill (HB) 2545 passed, identified 6 flame retardants to be considered for inclusion on Chemicals of High Concern to Children (CHCC) list: • Triphenyl phosphate (TPP); • Tris (1-chloro-2-propyl) phosphate (TCPP); • Bis (2-ethylhexyl)-2,3,4,5-tetrabromophthalate (TBPH); • (2-ethylhexyl)-2,3,4,5-tetrabromobenzoate (TBB); • Isopropylated triphenyl phosphate (IPTPP); and • Bis(chloromethyl) propane-1,3-diyltetrakis (2-chloroethyl) bisphosphate (V6) • These 6 will be evaluated against CHCC criteria, may be added to CHCC list 33
  • 34. Wal-Mart Requests Removal of Chemicals • Wal-Mart asking suppliers to remove formaldehyde, triclosan and 6 other substances from products • Per Wal-Mart, manufacturers must list targeted ingredients on packaging by 2018 and work to find alternatives • Affects ~90,000 items made by 700 manufacturers • So far, suppliers removed 95% of chemicals on list of products sold in U.S. • Chemicals on list include: • Toluene (used in paint thinners, nail polish, fragrances) • Diethyl phthalate (plasticizer in cosmetics, insecticides, aspirin) • NPE (surfactants in industrial applications, products like laundry detergent) • Butylparabens (preservative in cosmetics) • Propylparaben (preservative) 34
  • 35. US Rule on Triclosan & Triclocarbon • US FDA issued a final rule on safety and effectiveness of antibacterial soaps • FDA removed triclosan, triclocarbon from OTC hand and body washes • The final rule applies to consumer antiseptic wash products intended for use with water and rinsed off after use. 35
  • 36. US Bills on Endocrine-disrupting Chemicals • Senator Dianne Feinstein (D-CA) introduced two bills concerning endocrine-disrupting chemicals (EDCs) • Personal Care Products Safety Act • BPA in Food Packaging Right to Know Act • Feinstein compares European Union's regulation of EDCs to US legislation • To "address the health effects caused by endocrine-disrupting chemicals through updated federal safety oversight" 36
  • 37. Danish Retailer to Eliminate Toxins • Danish retailer, Coop, plans to phase out 12 substances/groups of chemicals from private label products by end of 2017 • “Dirty dozen” includes: • Bisphenol A (BPA); • Fluorinated compounds; • Pesticides; • PVC and phthalates; • Chemicals in textiles; • Substances identified as SVHCs; • Allergenic scented substances, preservatives; • Tricoslan and • Preservative methylisothiazolinone (MI) • Has stopped selling some products, such as Colgate Total toothpaste, which contains triclosan, Huggies baby wipes, which contain MI 37
  • 38. Europe Amends REACH Skin Sensitivity Testing • European Commission (EC) Commission Regulation (EU) 2016/1688 amending Annex VII to REACH as regards skin sensitisation • Alternative in chemico / in vitro test methods for skin sensitization • Test methods may allow assessment of skin sensitisation without need for in vivo testing • Goal to reduce animal testing 38
  • 39. Philippines Circular on Zinc Oxide • Philippines Food and Drug Administration (FDA) Circular No. 2016- 009, Reiteration on the Classification of Diaper Rash Creams/ Lotions/Ointments/Powders and Other Products Containing Zinc Oxide • Diaper rash creams, ointments, etc., containing zinc oxide may be considered cosmetics or drugs, dependent upon claims to prevent or treat disease • FDA recommends manufacturers, distributors, importers, sellers secure authorizations prior to sale 39
  • 40. EPA Issues National Rule on Formaldehyde • US EPA issued a final rule regarding exposure to formaldehyde from wood products • Products include: hardwood plywood; medium-density fiberboard; particleboard; household, other finished goods containing these products • Testing requirements to ensure compliance • Requirements for labeling, recordkeeping and enforcement provisions • Rule is based on California Air Resources Board (ARB) regulation • Takes force in one year 40
  • 41. Turkey Notification on Hazardous Substances • Turkey's Ministry of Economy enacted Notification Number: 29699 on Control of Import Inspection & Notification of Some Consumer Products (Product Safety & Inspection: 2016/25) • Consumer products, test parameters listed, including: • Art materials: To be tested for azo dyes, heavy metals, phthalates • Gloves: To be tested for cadmium, dioctyltin • Jewelry: To be tested for cadmium, nickel • Phone cases: To be tested for azo dyes, cadmium • Sanitary products: To be tested for azo dyes, dioctyltin • Watches: To be tested for azo dyes, cadmium, nickel 41
  • 42. Vietnam Guidance on Azo Dyes & Formaldehyde • Vietnam's Ministry of Industry and Trade reminds industry that textiles products are subject to Circular No. 37/2015/TT-BCT starting 1 July 2016 • Azo dyes: 30 ppm • Formaldehyde: • Textile products for children under 36 months of age: 30 ppm • Textile products in direct contact with skin: 75 ppm • Textile products without direct contact with skin: 300 ppm 42
  • 43. Indonesia Regulation on Hazardous Substances in Baby Clothes • Indonesia enacted No. 47 / M-IND / PER / 7/2016, on azo dyes, formaldehyde and heavy metals from the fabrics used for baby clothes • Establishes conformity assessment procedures to ensure compliance with Indonesian restrictions on azodyes, formaldehyde and heavy metals in fabrics for baby clothes 43
  • 44. REACH Footwear Guideline Updated • PD CEN/TR 16417:2016, Footwear Industry Guideline for Substances of Very High Concern (Annex XIV of REACH), Standard • Supersedes PD CEN/TR 16417:2012 • Provides guidelines on usage, presence of substances of very high concern (SVHC), apply to footwear 44
  • 45. European Union Decision on Footwear Ecolabel • Establishing the Ecological Criteria for the Award of the European Union (EU) Ecolabel for Footwear, Decision No. 1349/2016/EU • Criteria for awarding EU Ecolabel to footwear includes: • Volatile organic compounds (VOCs); • Hazardous substances in product/ components and • Restricted Substances List (RSL) 45
  • 46. EU Considers Restrictions on CMRs in Textiles • EC proposed fast-track restriction of 286 carcinogenic, mutagenic, reprotoxic (CMR) substances in textiles in two phases • First phase scope limited to articles coming into direct contact with skin • Wider scope to be considered in second phase, may include: • Floor coverings; • Carpets; • Upholstery; • Clothing accessories and • Leather articles • REACH Committee determines which substances to restrict 46
  • 47. Eurasian Economic Commission Proposes Regulation of Textiles • Customs Union seeks to clarify, simplify textiles, light industry goods certifications, conformity assessment procedures • New standards set for substances in textiles, light industry products made of polyvinyl chloride (PVC), polyurethane • Cadmium; • Chloroethyl; • Toluene diisocyanate and • Zinc • Migration controls of substances from inner surface of footwear • Effective one year after each member country signs • Once in place manufacturers only need to declare if articles contain harmful substances 47
  • 48. China National Standard for Juvenile Textiles • SAC implemented GB 31701-2015, Safety Technical Code for Infants’ and Children’s Textile Products • Limits on 6 plasticizers, lead and cadmium • Implemented 1 June 2016 • 2-year transition period for compliance 48
  • 49. Canada Nanotechnology Bill • Canada House of Commons first reading of Act to amend the Canadian Environmental Protection Act, 1999 (CEPA) (nanotechnology) (C-287) • Would implement investigation, assessment procedures of nanomaterials • Mandates risk assessment process to identify potential benefits, risks of nanotechnologies before nanoproducts enter market • Create national inventory regarding nanotechnology, using information collected under CEPA and “any other information to which the Ministers have access” 49
  • 50. US Reports on Conflict Minerals • More than 1,200 companies filed conflict mineral reports due to U.S. Securities and Exchange Commission by June 2016 • More than 70% unable to determine results • U.S.-listed companies required to investigate supply chain for tin, tantalum, tungsten, gold, under 2010 Dodd-Frank Act rule, meant to stop mining revenue to militia groups in Democratic Republic of the Congo, adjacent countries • UN says rebels still profiting, despite laws 50
  • 51. US Bill on Conflict Materials • United States (US) House Financial Services Committee amended bill to repeal US's conflict minerals reporting rule, HR 5983, Financial CHOICE [Creating hope and opportunity for investors, consumers and entrepreneurs] Act • Would repeal section requiring due diligence, reporting on whether sourcing of conflict minerals supports armed groups in Democratic Republic of Congo (DRC), or neighboring countries 51
  • 52. Denmark Flame Retardant Categories • Danish Environmental Protection Agency (MST) issued a Category approach for selected brominated flame retardants • Grouped BFRs found in 2014 MST survey on 67 brominated flame retardants • (Q)SAR predictions of environmental, health effects within initial groups generated, investigated • 61 BFRs need further investigation • Aim is to address groups of BFRs in regulations 52
  • 53. Canada amends Prohibition Regulations • Prohibition Regulations, 2012, amended to prohibit: • Hexabromocyclododecane (HBCD); • Perfluorooctanoic acid, salts, precursors (PFOA); • Long-chain perfluorocarboxylic acids, salts, precursors (LC-PFCAs); • Polybrominated diphenyl ethers (PBDEs) and • Perfluorooctane sulfonate, salts, precursors (PFOS) • Permitted uses include: • Adhesives and coatings for aircraft refinishing and • Semiconductor manufacturing process 53
  • 54. Eurasian Economic Commission Proposes RoHS-like Legislation • Eurasian Economic Commission (EEC) approved draft technical regulations of Eurasian Economic Union (EAEC) "On Restrictions on the Use of Hazardous Substances in electrical and electronics products“ • Would restrict lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, PBDEs in EEE • In alignment with international practice, including EU’s RoHS 2 • Will be considered November 2016 54
  • 55. Singapore Enacts RoHS Legislation • Singapore Ministry of the Environment and Water Resources approved Order 263/2016 • Adds restrictions for six hazardous substances in electrical and electronic equipment: • Cadmium (0.01%) • Hexavalent Chromium (0.1%) • Lead (0.1%) • Mercury (0.1%) • Polybrominated biphenyls (PBB) (0.1%) • Polybrominated diphenyl ethers (PBDE) (0.1%) • Products covered: Mobile phones, laptops, refrigerators, air conditioners, televisions, washing machines • Batteries, products designed for industrial use excluded • Enters force 1 June 2017 55
  • 56. New Zealand Bans Products Containing Asbestos • New Zealand Environment Minister prohibited the import of products containing asbestos • Inventory from 2014 shows asbestos no longer imported for use in buildings or where public exposure likely; still imported for specialist products, such as gaskets, seals and brake linings • Permits issued if no alternative product available/if alternative disproportionately expensive, in which case, importer must show risk of asbestos exposure can be safely managed • Effective 1 October 2016 56
  • 57. New Zealand Proposes POPs Legislation • New Zealand Environmental Protection Authority (EPA) proposed legislation to comply with international obligations regarding Persistent Organic Pollutants (POPs) • Would ensure compliance with Stockholm, Rotterdam Conventions • All but two of proposed additions to POPs list no longer in New Zealand, not approved under legislation, or being phased out • Submissions close 27 October 2016 57
  • 58. Commentary on Ecuador Battery Regulation • Ecuador’s Ministry of Industry and Productivity (MIPRO) approved Resolution 16227, First Revision of Ecuadorian Technical Regulation (RTE) 105 on batteries • Content limits of 0.0005% mercury, 0.002% cadmium by weight remain • RTE 105 (R): • Provides more options for meeting product requirements; • Adds more options for test methods to prove conformity and • Adds more documentation for certification • Takes effect 28 December 2016 58
  • 59. CA Adopts Prop 65 rule on ‘Clear & Reasonable Warnings’ • CA OAL approved adoption of amendments to “ Clear and Reasonable Warnings” for Proposition 65 • Clear, reasonable warning requirements; general provisions • Interested parties may request lead agency adopt specific product, chemical, or area exposure warning, or may request guidance from lead agency • Stakeholders not required to provide separate warnings to each exposed individual • Party to court-ordered settlement/ final judgment deemed to be providing “clear and reasonable” warning if compliant with order/ judgment • Operative 30 August 2018; in interim, businesses may comply with current or new regulation 59
  • 60. CA BPA Emergency Regulation Extended • California's OAL extended the emergency regulations on Proposition 65 warnings for bisphenol A (BPA) in canned, bottled food, drink by 90 days • Takes effect 17 October 2016 60
  • 61. Recent CA Prop 65 Settlements • Audio listening devices: 1,000 ppm di(2-ethylhexyl) phthalate (DEHP) • USB cords: 1,000 ppm of diisononyl phthalate (DINP) • Vinyl Zippered Mattress Protectors: 1,000 ppm of DEHP • Strainers: 1,000 ppm of DEHP and di-n-butyl phthalate (DBP) • Exercise mats: 1,000 ppm of DINP and DEHP 61
  • 62. Recent Prop 65 Chemical Listings • Chemicals listed in Q3 to cause cancer are: • Bromodichloroacetic acid (CAS No. 71133-14-7) • 1-bromopropane (CAS No. 106-94-5) • Furfuryl alcohol (CAS No. 98-00-0) • Office of Environmental Health Hazard Assessment (OEHHA) intends to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) as known to cause reproductive toxicity 62
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