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Chemicals QuarterlyQ2 2013

Stacey Bowers, MILSGlobal Regulatory Specialists.bowers@complianceandrisks.com

13 August 2013

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Welcome to the Chemicals Quarterly!

• Get an overview of the latest proposed, amended and enacted regulations and standards on restricted substances globally

• Broad coverage of products, countries and chemicals

o Each slide is a quick and dirty look at a regulation or standard

o If a given slide doesn’t apply to you, the next one may!

o If you have questions at any stage, please email us at AskOurExperts@complianceandrisks.com. We love answering compliance questions…

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EFSA public consultation on BPA

• EFSA announced a public consultation on its updated exposure

assessment of BPA in Europe

• EFSA concluded that diet is the major source of BPA exposure

for all populations

• EFSA evaluated intakes of BPA through food and drink,

and found they were well below the Tolerable Daily Intake

(TDI) of 0.05 mg/kg of body weight (mg/kg bw/day)

• Stakeholders can comment on the draft exposure

assessment from mid-July to mid-September 2013

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OEHHA removes BPA from Prop 65 list

• California’s OEHHA removed BPA from the list of

chemicals known to cause cancer or reproductive

toxicity per Proposition 65

• The chemical was added in April 2013

• On 19 April 2013, the Honorable Raymond M.

Cadei issued a preliminary injunction requiring

OEHHA to delist the chemical in ACC v OEHHA,

et al., pending final resolution of the case

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Feinstein introduces BPA labeling bill

• Senator Dianne Feinstein (D-CA) introduced a federal bill,

S.1124, to create the BPA in Food Packaging Right to Know

Act of 2013

• The bill would require labels on consumer food packaging that

contains BPA

• The bill would also require a safety assessment of

food containers with BPA

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Markey introduces federal BPA ban

• Congressman and Senator-Elect Ed Markey (D-MA) introduced

a federal bill, H.R. 2248, to create the Ban Poisonous Additives

Act of 2013

• The bill would ban reusable food and beverage containers, as

well as food packaging, containing BPA

• The bill would take effect in 180 days; however, the bill would

allow a temporary waiver

• The bill would also require the FDA to reexamine approved

food additives and food contact substances

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Nevada bans BPA

• Nevada enacted AB 354, to ban certain products

containing BPA

• Starting 1 January 2014, bottles and cups to

be filled with liquid or food for consumption

by children under 4 years old are banned

• Starting 1 July 2014, the ban extends to

containers for baby food or infant formula

containing intentionally-added BPA

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Minnesota expands BPA ban

• In May 2013, Minnesota expanded its ban of certain products

containing BPA

• Previously, the law banned BPA in empty bottles or cups

intended to be filled with food or liquid for children under 3

years old

• The ban was expanded to include containers for infant formula,

baby food, or toddler food that contain intentionally-added BPA

• The ban takes effect 1 August 2014

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Maine amends reporting of priority chemicals

• Maine enacted Chapter 232 (S.P 153/ L.D. 373) to amend the Toxic Chemicals in Children’s Products Law

• Previously, companies were required to report when their children’s products contain a priority chemical within 180 days of the chemical being identified

• The amendment requires companies that begin selling after the 180-day reporting period to provide a report within 30 days of the sale

• To date, Maine has identified 3 priority chemicals: BPA, nonylphenol (NP) and nonylphenol ethoxylates (NPEs)

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North Carolina bill to ban BPA, TRIS & phthalates

• North Carolina's General Assembly is considering HB 848, to

protect children from health impacts of toxic chemicals

• The bill would:

o ban children's products containing BPA,

o restrict phthalates – defined as DEHP, DBP, BBP, DINP, DIDP and DnOP – in children's products, with a limit of 1,000 ppm, and

o restrict TRIS – defined as TDCPP or TCEP – in children's products, with a limit of 50 ppm in any component

• Additionally, the bill would establish a list of chemicals of high concern and require alternatives assessments

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Delaware bills on TRIS & other CHCs

• Delaware's House is considering 2 bills, HB 110 and HB 111, on chemicals of high concern in consumer products

• HB 110 would restrict TRIS – defined as TDCPP or TCEP – in children's products or residential upholstered furniture, with a limit of 50 ppm in any component starting 1 July 2014

• Starting 1 July 2015, the bill would ban children's products or residential upholstered furniture containing flame retardants that are chemicals of high concern

• HB 111 would establish a list of between 50-100 chemicals of high concern by 1 January 2014

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Maryland bans TCEP

• Maryland enacted HB 99, to ban the import, sale, or offering of child care products containing TCEP

• The law applies to child care products, defined to mean consumer products intended for children under 3, including baby products, toys, car seats, nursing pillows, crib mattresses and strollers

• The law establishes a limit of 1% of TCEP by mass in child care products

• The law takes effect 1 October 2013

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Vermont bans TCEP, TCPP & TDCPP

• Vermont enacted Act No. 85 (SB 81), to ban children’s products and residential upholstered furniture containing TCEP, TCPP and TDCPP

• The Act restricts the manufacture, distribution or sale of children’s products or residential upholstered furniture containing TCEP, TCPP or TDCPP in excess of 0.1% by weight in, any product componento Note: For select audio, video and computer equipment, these

thresholds should be applied to individual articles, not components, consistent with the EU’s REACH

• The Act takes effect 1 January 2014

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Michigan bills on chemicals of concern

• Michigan is considering HB 4795, SB 399 and SB 400, to compile a list of chemicals that are identified to be:o Carcinogens, reproductive or developmental toxicants,o Endocrine or hormone disruptors, o Persistent, bioaccumulative and toxic, oro Very persistent and very bioaccumulative

• Per the bills, the list would be required by 1 July 2014

• The bills would also provide for the state to participate in an interstate chemicals information clearinghouse, to collaborate on collection and dissemination of information on chemical hazards and on assessment of alternatives

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Connecticut bill on chemicals of high concern

• Connecticut’s General Assembly is considering HB 6526, on children’s products and chemicals of high concern

• The bill would require the creation and maintenance of a list of priority chemicals of high concern to children

• One year after its passage, the bill would require manufacturers to disclose intentionally-added priority chemicals in their children’s products

• Two years after its passage, the bill would require manufacturers to submit a Priority Innovation Plan for removal of the priority chemical from their children’s products

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New York State bills on chemicals of high concern

• The New York Assembly is considering A 6328/ S 4614, to establish lists of chemicals of high concern, based upon Maine’s list

• The bills would require publication of lists of priority chemicals and CHCs within 180 days of publication

• The bills would also require manufacturers to report on intentionally-added priority chemicals in children’s products within 12 months

• Starting 1 January 2018, the bills would ban the sale of children’s products containing priority chemicals that have been listed for at least one year

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Florida bills on chemicals of high concern die

• The Florida legislature adjourned without passing either HB 773 or SB 1154

• Each of the bills would have established a state list of chemicals of high concern

• The bills are now dead, as Florida does not allow bills to be carried over into the next legislative session

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EHN reports on CHCCs reports to Washington

• Environmental Health News (EHN) assessed filings of 59 brands and retailers, as per Washington state’s Children’s Safe Product Act

• Cobalt was the most-commonly reported CHCC, in over 1,200 products in 40 categories, including plastic blocks, ride-on toys and bibs

• Other commonly-reported substances included:o ethylene glycol, o antimony, o molybdenum, o methyl ethyl ketone, o BPA and o parabens

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Danish postpones phthalate ban until 2015

• In November 2012, Denmark banned DEHP, DBP, BBP, and

DIBP in indoor articles intended for direct contact with the skin

or mucous membranes, starting December 2013

• After a survey of actual use of these phthalates, the ban has

been postponed until 2015

• The Ministry of Environment may also enact labeling

requirements for phthalates in indoor articles

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Vietnam proposes restrictions on lead & cadmium in food contact

• Vietnam has proposed a technical regulation on the safety of

glass, ceramic and enameled food packaging

• The proposal would establish restrictions on lead and cadmium

in food packaging

• The proposal would also establish a test method for

determining compliance

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GSO final draft regulation on food contact plastics

• The GCC Standardization Organization (GSO) issued a final

draft regulation on plastic food packages

• The regulation would establish general requirements for plastic

food packages, including an overall migration limit

• The regulation would also establish restrictions on:

o VCM in PVC

o styrene in polystyrene

o acrylonitrile monomer

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Health Canada guide to children’s jewelry safety

• Health Canada issued a new Industry Guide to Children’s

Jewellery, summarizing the safety requirements for children’s

jewelry

• The Guide explains Canada’s lead restrictions in children’s

jewelry and specifies the analytical test methods to be used

• Additionally, the Guide outlines Health

Canada’s proposed guidelines for cadmium

in children’s jewelry

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ASTM publishes safety standard on adult jewelry

• ASTM published ASTM F2999:2013, Standard Consumer

Safety Specification for Adult Jewelry

• The standard establishes safety requirements and test methods for adult jewelry, including:

o lead in base materials,

o heavy metals in surface coatings, and

o cadmium in substrates

• This standard applies to jewelry items not subject to ASTM

F2923:2011, Children’s Jewelry Safety Standard

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GAO reports on EPA’s chemical control efforts

• The US Government Accountability Office (GAO) evaluated EPA’s efforts to strengthen chemical management per TSCA

• This report outlines EPA’s challenges with: o obtaining adequate information on chemical toxicity and exposure;o banning or limiting chemicals ando disclosing data and managing confidentiality

• GAO reports EPA has made progress implementing its approach

• GAO recommended EPA require companies to provide chemical data they submitted to foreign governments, reassert confidentiality claims and other strategies

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Congress bill to amend TSCA

• The late Senator Frank Lautenberg (D-NJ) proposed the federal bill S.696, the Safe Chemicals Act of 2013

• The bill would amend TSCA to:o protect the health of children, workers, consumers, and the public

and to protect the environment from harmful exposures to chemical substances;

o promote the use of safer alternatives;o require chemicals in commerce to meet a risk-based safety

standard that protects vulnerable and affected populations and the environment;

o require companies to provide sufficient health and environmental information for chemical substances; and

o other requirements

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Oregon urges Congress to modernize TSCA

• Oregon’s Legislative Assembly issued LC 4041, urging the federal Congress to modernize TSCA

• LC 4041 asks Congress to:o phase out persistent, bioaccumulative and toxic chemicals

whenever possible;o assess all chemicals against a health standard that protects the

environment and all people, especially vulnerable populations; ando preserve states' rights to regulate chemicals and provide

resources for implementation of chemical regulations at the state level

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IC2 draft Guidance for Alternatives Assessment

• The Interstate Chemicals Clearinghouse (IC2) announced a draft Guidance for Alternatives Assessment and Risk Reduction for public review

• The draft outlines a process for Alternatives Assessment (AA), defined as: o identifying and comparing potential chemical and nonchemical

alternatives that can be used as substitutes to replace chemicals or technologies of high concern

• The draft is intended to enable member states to standardize the AA process and share AA results

• Comments were received from stakeholders including AAFA, Hewlett-Packard, NWF, TIA, and UMass

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ZDHC Joint Roadmap, Version 2

• The Zero Discharge of Hazardous Chemicals Programme (ZDHC) Group released Version 2 of its Joint Roadmap

• The Roadmap outlines a strategy to achieve zero discharge of hazardous chemicals in the global apparel and footwear industry by 2020

• Version 2 presents a long-term vision, 2015 milestones and 2020 goals

• The initiative is led by stakeholders including adidas, Esprit, H&M, Inditex, Levi Strauss & Co.,M&S, New Balance, NIKE, PUMA and others

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ECHA supports restriction on chromium (VI) in leather

• During its 18th meeting, ECHA's Committee for Socio-Economic Analysis (SEAC) supported a Danish proposal to restrict chromium (VI) in leather articles

• SEAC confirmed, the proposed restriction is the most appropriate EU-wide measure to address risks from chromium (VI) in leather

• The proposed restriction may result in a limit of 3 ppm chromium (VI) in leather articles, as per EN ISO 17075:2007

• The proposed restriction is expected to enter into force in early 2015

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Informal agreement on revised EU Batteries Directive

• The EU Council and Parliament have reached informal agreement on the revision of the EU's Batteries Directive

• The revised Directive expands the ban of portable batteries and accumulators containing more than 0.002% cadmium to include portable batteries and accumulators containing cadmium intended for use in cordless power tools

• The revised Directive also bans button cells with mercury content of less than 2% by weight

• Formal approval is expected in September 2013, followed by an 18-month implementation period

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China proposes revised toy safety standards

• SAC has proposed revisions to the Chinese toy safety standard, GB 6675, to be harmonized with the latest revisions of ISO 8124

• Additionally, SAC proposes to break the standard into four

separate standards, including:o GB 6675.4, Safety of Toys, Part 4: Migration

of Certain Elements

• The proposed standards are open for comment through 31 August 2013

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CEN publishes new & amended toy standards

• The European Committee for Standardization (CEN) amended EN 71-3:2013, on migration of certain elements in toys

o The standard includes new limits on barium in toys

• CEN also published a new standard, EN 71-12:2013, on N-nitrosamines and N-nitrosatable substances in toys

• The European Commission has “harmonized” both standards, per the EU’s Toy Safety Directive

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EU considers expanded restrictions on PAHs

• The EU's REACH Committee is considering expanding restrictions on polyaromatic hydrocarbons (PAHs) per REACH

• The proposals would restrict Benzo[a]pyrene, Benzo[e]pyrene, Benzo[a]anthracene, Chrysen, Benzo[b]fluoranthene, Benzo[j]fluoranthene, Benzo[k]fluoranthene and Dibenzo[a,h]anthracene,o with a limit of 1 ppm in products such as:

sports equipment, like bicycles, golf clubs and racquets;

household utensils and tools;

clothing and accessories; ando 0.5 ppm in toys and childcare articles

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Minnesota bans formaldehyde in children’s products

• Minnesota’s Governor enacted Chapter 58 (HF 458), to ban formaldehyde in children’s products

• The law applies to children’s products, defined to mean products to be applied or introduced into a the body of a child under 8, including food, beverages, toys, and medical devices

• The law prohibits the sale of children’s products containing intentionally-added formaldehyde

• The prohibition takes effect 1 August 2014

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EPA proposes formaldehyde emissions standards

• The US EPA is seeking public comment on proposed rules to restrict formaldehyde

• The first proposal, the Formaldehyde Standards for Composite Wood Products Act, would establish formaldehyde emission standards for domestic and imported wood products, including hardwood plywood, MDF, and particleboard

• The second contains a framework for a Third-Party Certification Program to ensure compliance with emission standards

• The proposed rules were open for public comment through 9 August 2013

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Revised China RoHS likely

• The revised version of China’s Management Methods for the Control of Pollution by Electrical and Electronic Products (China RoHS) is likely to be enacted in fall 2013

• The new measures are expected to involve a significant change in scope, from a focus on information technology products to electrical and electronic products generally

• The timetable was revealed by the Ministry of Industry and Information Technology (MIIT) at a quality management conference in Beijing in June 2013

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Norway amends PFOA ban to include consumer products

• The Norwegian Ministry of Environment amended its prohibition on perfluorooctanoic acid (PFOA) and salts and esters of PFOA to include in consumer products, textiles and other products

• The law established new limits of: o 0.001% PFOA in a mixture, o 1 microgram/ square meter in textiles, ando 0.1% in component parts

• The new limits take effect 1 June 2014

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Norway’s KLIF guide to chemical legislation

• Norway's Climate and Pollution Agency (KLIF) prepared a guide to chemicals legislation

• The guide leads importers through their obligations, step-by-step

• The guide covers chemicals in consumer products, including apparel, electrical products, furniture, and toys

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EPA includes 109 chemicals in 2nd endocrine list

• EPA published a second list of chemicals to be included in its Endocrine Disruptor Screening Program (EDSP)

• The list contains 109 chemicals, including 68 commercial chemicals and 41 pesticide active ingredients

• EPA began a 30-day public comment period on the Information Collection Request (IRC), to evaluate the implications of imposing data requests for these chemicals

• EPA is expected to issue orders requesting screening data under the Program as early as September 2013

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South Korea enacts K-REACH

• On 22 May 2013, the South Korean government published the law on the Registration and Evaluation of Chemicals (commonly known as “K-REACH”)

• K-REACH is intended to:o prescribe the process for chemical registration, evaluation,

assessment of hazards and risks of chemical substances and products containing hazardous chemical substances, and

o protect public health and the environment

• The law takes effect 1 January 2015

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Germany’s UBA to crack down on REACH infringements

• Germany’s Federal Environment Agency (UBA) has announced new Chemicals Regulations Sanctions

• Companies who violate EU REACH reporting requirements under could face fines of up to €50,000

• For breaches in regulations that endanger life, those responsible could face up to 5 years in prison

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List of SVHCs under REACH now totals 144

• In June 2013, ECHA added a number of chemicals to its Candidate List of Substances of Very High Concern for Authorisation, per REACH

• Newly-added SVHCs include:o Cadmiumo Cadmium oxideo Ammonium pentadecafluorooctanoate (APFO)o Pentadecafluorooctanoic acid (PFOA)o Dipentyl phthalate (DPP)o 4-Nonylphenol, branched and linear, ethoxylated

• The List of SVHCs now totals 144

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California Governor proposes Prop 65 reforms

• California Governor Brown proposed reforms to strengthen and restore the intent of Proposition 65

• The aims of the reform are to:o Cap or limit attorney’s fees in Prop 65 caseso Require stronger demonstration by plaintiffs that they have

information to support claimso Require greater disclosure of plaintiff’s informationo Set limits on the amount of money that can go into settlement

funds, in lieu of penaltieso Provide the state with the ability to adjust the level at which

Prop 65 warnings are needed for chemicals that cause reproductive harm

o Require more useful information to the public on exposure and risk

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Prop 65 60-day notices in Q2 2013

• California’s Attorney General received 247 60-day notices in Q2 2013

• DEHP was the most-notified chemical, with 108 notices

• Lead and lead compounds were the second-most notified chemical, with 72 notices

• TDCPP was third-most notified, with 57 notices

• The product most notified against was upholstered and stuffed seating and resting products allegedly containing TDCPP, TCEP and/ or DEHP, with 69 notices

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Prop 65 settlements in Q2 2013

• Sunglasses: 1,000 ppm DEHP

• Vinyl/ PVC rainwear: 1,000 ppm DEHP

• Vinyl/ PVC pillows: 1,000 ppm DEHP and 1.0 microgram lead per cm2 and 100 ppm lead

• Kitchen tools: 1,000 ppm each of DEHP or lead

• Vinyl/ PVC hand tool grips: 1,000 ppm each of DEHP or DBP and 1.0 microgram lead per cm2 and 100 ppm lead in each accessible part

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Recalls in Q2 2013

• CPSC announced 82 product recalls; none of these was due to chemical hazards

• The EU announced 75 RAPEX notifications due to chemical risk, including:• T-shirts containing azo dyes• Climbing gloves containing chromium (VI)• Ice skates containing chromium (VI)• Sandals and shoes containing chromium (VI)• Dolls containing DEHP• Stationery containing DEHP• False nails containing DBP• Pants containing nickel• Work gloves containing nitrobenzene

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Recalls in Q2 2013

• Health Canada announced 4 recalls due to chemical hazards:o children’s balloon blowing kitso espresso makers containing leado heating/ cooling mats for dogs and cats,

containing diethylene glycol which can be released from the mat if it is damaged

o hot drink makers containing lead

• Australia’s ACCC announced 69 recalls; none of these was due to chemical hazards

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Questions?

• Need details about the chemical bills, regulations and standards outlined in this webinar?

• Contact Stacey to:o share your own updates;o register for the next Chemicals Quarterly webinar; o sign up for a free trial of C2P; oro schedule a “needs assessment”!

s.bowers@complianceandrisks.com

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