|

Chemicals QuarterlyQ3 2013

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

3 October 2013

1

|

Welcome to the Chemicals Quarterly!

• The latest proposed, amended and enacted regulations and standards on restricted substances globally

• Broad coverage of products, countries and chemicals

o Each slide is a quick and dirty look

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

2

|

CA launches Safer Consumer Products Program

• On 1 October 2013, DTSC launched California's Safer Consumer Products (SCP) Program

• To kick it off, DTSC posted 2 lists of Candidate Chemicals online

o The Informational Candidate Chemicals List includes chemicals that may be named as Chemicals of Concern if they are identified as part of a product-chemical combination listed as a Priority Product

o The “Initial” Candidate Chemicals Informational List represents the prioritized Candidate Chemicals that will be used for identification of Priority Products

33

|

CA launches Safer Consumer Products Program

• DTSC also posted a Toxics Information Clearinghouse (TIC) website

o The TIC's is a decentralized system for collection, maintenance, and distribution of information on specified chemicals

o The TIC provides a portal to multiple web-based sources of chemical-specific information for hazard traits, toxicity endpoints, and other properties

44

|

WA proposes amendment to CSPA Reporting Rule

• Washington State's Department of Ecology is considering an amendment to its Reporting Rule per the CSPA

• The proposed amendment would add TDCPP to the reporting list of chemicals

• Additionally, the proposed amendment would remove n-butanol from the reporting list

• Ecology expects to adopt the amendment around 16 October 2013, with the first reports due on 28 February 2015

55

|

OR bill on chemicals of concern dies

• Oregon’s House Bill 3162 has died

• The Bill would have required the Oregon Health Authority to maintain list of designated high priority chemicals of concern for children’s health used in children’s products

• The Bill would also have required manufacturers of certain children’s products to notify the authority regarding chemicals on the list

• Democratic Senator Diane Rosenbaum, the majority leader, hopes the Legislature will take up the issue again next session

66

|

House bill to restrict flame retardants in children’s products

• The federal House of Representatives is considering the “Decrease Unsafe Toxins Act”

• H.R. 2934 would amend CPSIA to prohibit flame retardant chemicals in children’s cushioned products, such as high chairs, strollers, infant walkers and booster seats

• The bill defines “flame retardant chemicals” to mean organohalogen or organophosphorous compounds, such as PBDEs

77

|

EC proposes limits for BPA & flame retardants in toys

• In mid-July, the EC notified the WTO of 2 drafts to amend the Safety of Toys Directive

o One would establish a migration limit of 0.1 mg/l of BPA, in accordance with EN 71-10 and EN 71-11

o The other would establish limits of <5 ppm of each of the chlorinated flame retardants, TCEP, TCPP and TDCP, in toys

• The draft Directives are open for comments for 60 days

• If enacted, they will enter into force 18 months after adoption

88

|

ECHA consultation on BPA

• ECHA launched a public consultation to amend the harmonized classification and labeling of BPA, from reproductive toxicity category 2 to reproductive toxicity Category 1B

• The consultation was undertaken in response to a French proposal

• The proposal is focused on the adverse effects on sexual function and fertility, not on developmental toxicity or other hazard classes

• The comment period ends 11 October 2013

99

|

FDA amends BPA regulations

• The US FDA amended 21 CFR 175, to remove provisions for BPA-based epoxy resins as coatings in packaging for infant formula

• The Rule was enacted because these uses have been abandoned by the industry

• The Rule took effect 12 July 2013

1010

|

Philippine bills on toxic chemicals in toys

• The Philippine House and Senate are considering 4 bills to restrict toxic chemicals in toys, school supplies and childcare articles

• HB 62, HB 220 and HB 1920, and SB 1095 were each proposed in July

• The bills call for FDA to create a list of chemicals and substances which cause or may cause harm, injury or death, such as heavy metals, phthalates and BPA

• The bills would also require labeling to disclose and identify chemicals and substances

1111

|

EPA delays phthalates report pending CPSC report

• According Plastics Today, EPA is delaying its review of phthalates, until a separate review is completed by CPSC

• The EPA review would be conduced per its DfE program

o The program helps consumers, businesses and institutional buyers identify products that are safer for the environment

• The CPSC review is being conducted by the Chronic Hazard Advisory Panel (CHAP), as established by CPSIA

o The CHAP is studying effects on children’s health from phthalates and phthalate alternatives in toys and childcare articles

1212

|

Environment Canada calls for phthalate data

• Environment Canada issued a notice calling for data on the use of several phthalates, including BBP, DBP, DEHP and DNOP, in 2012

• The notice applies to anyone who manufactured, imported or used a listed substance, at a total quantity greater than 100 kg, at a concentration >0.001% by weight, during the calendar year

o The notice applies to substances whether alone, in a mixture or in a product, or in a manufactured item, including products for children under 6, food contact articles, clothing and other consumer products

• Data must be provided by 13 November 2013

1313

|

South Korean notice on toxic substances in children’s products

• On 28 September, South Korea's Ministry of Environment enacted Notice No. 2012-195, establishing restrictions on toxic substances in children's products, as follows:o DNOP:

Transition due to oral exposure: ≤ 9.90×10/cm2/min, Transition due to dermal exposure: ≤5.50×10/cm2/min

o DINP: Transition due to oral exposure: ≤ 4.01×10/cm2/min Transition due to dermal exposure: ≤2.20 x 10/cm2/min

o NP: ≤0.1%

o TBT compounds: ≤0.1%

o The Notice will take force in one year

1414

|

ECHA issues final report on DIDP & DINP

• ECHA has reviewed the scientific evidence on the risks posed by articles containing DINP and DIDP

• Currently, these phthalates cannot be used in toys and childcare articles which can be placed in the mouth by children

• ECHA asserts, if the restriction were lifted, a risk from the mouthing of toys and childcare articles with DINP and DIDP cannot be excluded

• ECHA therefore concludes there is no evidence that would justify a re-examination of the existing restriction

1515

|

TIA survey about proposed lead restrictions in Canada

• The US TIA is surveying its members on a proposed expansion of Canada’s restrictions on lead in toys

• Under the proposal, the 90 ppm limit on lead in toys for children three and under would expand to toys for children 14 and under

• TIA’s survey asks whether the proposed expansion would:

o increase testing costs; o force members to stop selling toys in Canada; or o reduce the number of toys that they sell in Canada

• The survey is open through 7 October 2013

1616

|

EU amends restrictions on barium in toys

• The EU amended the Toy Safety Directive, to further restrict migration limits for barium in toys

• The amendments were undertaken after a review by SCHER

• The amended limits are as follows:

o 1,500 ppm in dry, brittle, powder-like or pliable toy materialo 375 ppm in liquid or sticky toy materialo 18,750 in scraped-off toy material

• These limits are also reflected in EN 71-3:2013, which has been “harmonized” per the Directive

1717

|

ECHA called for info on cadmium in plastics

• ECHA called for information on the use of cadmium and cadmium compounds, in particular cadmium-based pigments in plastic materials

• The survey is intended to assess the need for expanding the current restriction on cadmium, to cover plastics that have not yet been restricted per REACH

• The comment period ended 29 August 2013

1818

|

Denmark to enforce chemical restrictions

• The Danish Minister of Environment has committed to spend 20 million DKK on enforcement in the next three years

• Under its “Chemistry Control – Clean childhood” program, the Minister will inspect container ships filled with imported products

• Inspections will focus on consumer products, including toys, children’s apparel and electronic products

• The aim of the Program is to raise awareness of SVHCs

1919

|

ECHA calls for comments on NPs, NPEs & NMP

• On 19 September 2013, ECHA initiated a public consultation for the restriction of NPs, NPEs and NMP

• The consultation follows submissions by Sweden and The Netherlands

o The Swedish report proposed a restriction on textile articles that can be washed in water, if they contain NPs or NPEs exceeding 100 mg of the substance per kg of textile

• Comments must be received by 18 March 2014

2020

|

OECD survey on risk of chemicals to children's health

• OECD presented a report on methodologies and tools used to assess risk of chemicals to children's health

• The report is based on a survey of governments, universities, and industry and international organizations from countries including the EU, Australia, Italy, Denmark, Turkey and South Korea

• It covers: o definitions of terms, o hazard and exposure assessments, o risk characterization, o cohort studies and o combined exposure to multiple chemicals

2121

|

ECHA considers 7 SVHCs under REACH

• In response to dossiers submitted by Austria, Germany, the Netherlands and Sweden, ECHA is considering 7 possible SVHCs, including:

o Cadmium sulphideo DHPo C.I. Direct Red 28o C.I. Direct Black 38o Lead di(acetate)o Trixylyl Phosphate

• Comments must be received by 17 October 2013

2222

|

ECHA updates its chemical Navigator tool

• The Navigator is intended for stakeholders, including manufacturers, importers and producers of articles

• During a Navigator session the user answers a series of questions:

o whether the user manufactures or imports the substance, o at what tonnage, ando for what use

• The tool helps determine possible obligations under the REACH and CLP regulations

2323

|

Auto industry petitions ECHA on SVHCs & nanomaterials

• The auto industry has written ECHA requesting chemicals listed as SVHCs and nanomaterials be given unique substance identifiers

• The European Automobile Manufacturers Association (ACEA) and European Association of Automobile Suppliers (CLEPA) assert, variable naming of chemicals is impeding industry’s ability to comply with REACH

• The organizations urge ECHA to include a unique identifier, such as a CAS or EC number, to help to differentiate them from the bulk forms of materials

2424

|

Indian Ministry calls for “REACH-like legislation”

• C&R data partner, Chemical Watch, reports that India’s Ministry of Chemicals and Fertilizers is calling for “REACH-like legislation”

• A draft national chemical policy was issued in March, with responses due by end April

• The draft policy calls for consolidation of existing legislation and addressing:

o registration of substances;o a national inventory;o restricting and prohibiting substances

2525

|

OECD addresses manufactured nanomaterials

• OECD issued a Recommendation on safety of manufactured nanomaterials

o Manufactured nanomaterials are chemical particles that exhibit new characteristics, in contrast to the same material without nanoscale features

• OECD advised Member Countries to apply existing international and national chemical regulatory frameworks to manufactured nanomaterials

• It also advised use of the OECD Test Guidelines for the Safety Testing of Chemicals

2626

|

Oeko-Institut reports on 7 RoHS exemption requests

• The Oeko-Institute has launched a consultation to review 5 exemption requests under RoHS

• The exemptions relate to: • Cadmium in LEDs• Cadmium in light control materials • Lead in PVC in electrochemical sensors• Lead in solder in heart-lung machines• Mercury in electrical connectors

• The consultation ends on 11 November 2013

• C&R data partner, Paul Goodman, from ERA Technology Ltd, is monitoring the consultations closely

2727

|

RoHS2 labeling causes confusion

• C&R data partner, Leigh Holloway, from eco3, reports the new labeling requirements per RoHS2 (aka the RoHS Recast) have caused confusion within the E&E industry

• Under the first incarnation of RoHS, industry used “ad-hoc” symbols and verbiage to demonstrate compliance

• With the Recast, the CE Mark is the only permitted RoHS compliance mark

2828

|

IEC updates database on material declaration

• The IEC updated its IEC 62474 database on material declaration in electrotechnical industry

• The database is intended to be consulted in tandem with IEC 62474, on material declaration of products in the electrotechnical industry

• The database specifies:

o what substances, substance groups and material classes that need to be included in material declarations; and

o to software developers, specifications on the data format for the exchange of material declaration data

2929

|

South Africa phases out PCBs

• South Africa issued a Notice to phase out PCB materials and PCB-contaminated materials

• Per the Notice, it is prohibited to:

o use, process or produce PCB materials or PCB-contaminated materials;

o import PCB materials or PCB-contaminated materials or PCB waste into the Republic of South Africa, or export PCB materials or PCB-contaminated materials from South Africa; or

o sell PCB materials or PCB-contaminated materials in South Africa

3030

|

EPA expands Safer Chemical Ingredients List

• EPA added 130 chemicals to its Safer Chemical Ingredients List

o Included are 119 chemicals used in commercial and consumer cleaning products

• The List serves as a guide for DfE-labeled products, which must meet rigorous, scientific standards for protecting human health and the environment

• It also serves as a resource for:

o manufacturers making safer products; o health and environmental advocates encouraging

safer chemicals; and o consumers seeking safer products

3131

|

EPA extends deadline for comments on formaldehyde in wood

• In June, EPA issued a proposed rule to establish formaldehyde emissions standards for composite wood products, per TSCA

• The proposed standards are identical to those in place in California

• In August, EPA extended the comment period to 9 October 2013

• EPA has received 16 comments, from stakeholders such as the AAP, CEA, Georgia-Pacific & IKEA

3232

|

CA ARB proposes amendments to VOC requirements

• The California ARB proposed amendments to several of its regulations on VOCs, including:

o Antiperspirants and Deodorants Regulationo Consumer Product Regulationo Aerosol Coating Products Regulation

• The proposed amendments would lower the impacts VOC emissions have on formation of ground-level ozone

• If fully implemented, VOC emissions would be reduced by about 4 tons per day statewide

3333

|

No movement on proposed TSCA amendments

• In April 2013, the late Senator Frank Lautenberg (D-NJ) proposed two bills to amend TSCA, S.696 and S.1009

• The bills would amend TSCA to:

o protect the health of the public and the environment from chemical substances;

o promote safer alternatives;o require chemicals to meet a risk-based safety standard; ando require companies to provide health and environmental

information for chemical substances

• The bills have not moved since they were proposed

3434

|

EPA SNUR on LCPFAC chemicals for use in carpets

• EPA issued a SNUR, per TSCA, to report all new uses and imports of carpets containing long-chain perfluoroalkyl carboxylic (LCPFAC) chemicals

• The Rule requires manufacturers, importers or processors of any LCPFACs for use in carpets to notify EPA at least 90 days in advance

• This notification period is designed to allow the agency to limit these chemicals, due to risk to humans, animals and the environment

3535

|

Russia amends its restrictions on ODS

• In July, the Russian Federal Assembly adopted Law No. 226-FZ amending the law on environmental protection

• The Law will significantly increase control over the production, use and disposal of ozone depleting substances (ODS)

• The Law enters into force on 1 January 2014

3636

|

AAFA publishes 13th edition of its RSL

• AAFA has revised its RSL to the 13th edition, in conjunction with the International Product Safety & Restricted Substances Conference in Jakarta, Indonesia

• The RSL covers restricted substances in apparel, footwear and home textiles, providing the industry with "...clear and concise information on the newest developments in global product safety and chemical management standards”

• The RSL was updated to reflect changes spurred by REACH, as well as other US state and global regulations.

3737

|

AFIRM revises Restricted Substances Guidance

• The Apparel and Footwear International RSL Management (AFIRM) Group issued Version 2 of its Restricted Substance Guidance

• The Guidance is a review of all AFIRM brand RSLs

o AFIRM members include Adidas, Carhartt, Gap, Gymboree, J. Crew and other leading brands

• The Guidance assists and guides supply-chain participants with product quality and safety, andreduced environmental impact

3838

|

EU’s Biocidal Products Regulation takes force

• The EU’s Biocidal Products Regulation took force 1 September 2013

• The Regulation concerns biocidal products, used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of active substances within

• All biocidal products require an authorization before they can be placed on the market, and the active substances contained within must be previously approved

• The Regulation also aims to harmonize the market at the EU level

3939

|

Prop 65 settlements on flame retardants

• In September 2013, two Proposition 65 settlements were reached on TDCPP, TCEP, and TDBPP in children’s products

o Car seats with foam paddingo Changing pads with polyurethane foam

• Each calls for “no detectable amount," measured as 25 ppm each of TDCPP, TCEP, and/ or TDBPP in any material, component, or constituent of the product

• The car seat settlement provides for warning labeling through 31 December 2013

4040

|

Prop 65 settlements on flame retardants

• This comes after an April 2013 settlement, restricting flame retardants in foam-cushioned pads for children and infants, such as rest mats

• This settlement restricts any covered product in which the polyurethane foam has been treated with TDCPP

• Further, starting in June, it restricts any covered product in which the polyurethane foam has been treated with one of a series of chemical flame retardants, including TDCPP, TCEP, TCPP, PentaBDE, OctaBDE and DecaBDE

• Labeling is not allowed in this settlement

4141

|

CEH actions against cocamide DEA in cosmetics

• CEH testing found cocamide DEA, a cancer-causing chemical, in 98 shampoos, soaps and other personal care products

o Many tested products contained <10,000 ppm cocamide DEA, with one containing <20,000 ppm

• Per California Proposition 65, the organization filed a lawsuit against four retailers selling products containing cocamide DEA

• The organization also sent legal notices to more than 100 other companies that produce and/ or sell products containing the chemical

4242

|

OEHHA lists chemicals under Prop 65 consideration

• California’s OEHHA published a “tracking table” of chemicals under consideration for the Proposition 65 list

• The table lists:

o the chemicals, o the endpoint (toxic effect), o the authoritative body, o the basis for the possible listing, o the status of the chemical on the Prop 65 list, and o the next step in the listing process

• OEHHA will update the list on a regular basis

4343

|

CA Prop 65 reforms tabled until 2014

• The Sacramento Business Journal reports negotiations to reform California Proposition 65 have stalled

• Business leaders, environmentalists, attorneys, consumer organizations and state agencies hoped to introduce proposed amendments in the California Legislature before the midterm recess on 13 September

• Stakeholders disagreed over reforms, including “safe harbor” levels

• Meanwhile, the Legislature is still considering AB 227, to provide a 14-day grace period for violations of Prop 65 warnings

4444

|

CA Prop 65 60-day notices in Q3 2013

• California’s Attorney General received 248 60-day notices

• Chemicals

o DEHP was the most-notified chemical, with 111 noticeso Lead and lead compounds were the second-most notified

chemical, with 86 noticeso TDCPP was third-most notified, with 23 notices

• Products

o Personal care products, such as shampoo, soaps, shower gels and bath gels, were most-notified, with 97 notices

o Upholstered furniture was second-most-notified, with 56 noticeso Eyewear, including sunglasses, were third-most-notified, with 32

notices

4545

|

Recalls in Q3 2013

• CPSC announced 69 product recalls; 2 were due to chemical hazards:

o Youth beds, due to excess lead in painto Outdoor furniture, due to excess lead in paint

• The EU announced 553 RAPEX notifications; 255 were due to chemical risk, including:

o Plastic tolls excess DEHPo Jewelry containing excess nickelo Footwear containing excess chromium (VI)o False nails containing DBP

4646

|

Recalls in Q3 2013

• Health Canada announced 65 consumer product recalls; 4 were due to chemical hazards, including:

o Reed diffusers which pose a high level of toxicity through inhalation

o Air horns, which do not have mandatory consumer chemical product labeling

• ACCC announced 53 consumer product recalls; none were due to chemical hazards

4747

| 48

Enjoyed what you read? Sign up now for a free live webinar update on

Chemicals Quarterly, Q4!

www.complianceandrisks.com

Have you got a compliance question? Why don’t you email

askourexperts@complianceandrisks.com for free?!

|49 49