1

Chemicals QuarterlyQ3 2016

Presented by Stacey Bowers, MILS26 October 2016

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

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

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

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

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

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

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

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

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

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

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

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

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”

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

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

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

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

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

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

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’sToy Safety Directive

• The Customs Union includes Armenia, Belarus, Kazakhstan, Kyrgyz Republic and Russia

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

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)

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)

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

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"

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

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

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

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

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

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)

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

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)

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.

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"

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

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

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

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

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

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

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

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

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)

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

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

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

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”

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

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

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

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

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

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

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

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

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

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

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

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

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

63

Enjoyed what you’ve read?

Click here to check out our full list of on-demand webinars!