1

Chemicals QuarterlyQ1 2014

Presented by Stacey Bowers, MILS

Email: s.bowers@complianceandrisks.com 29 April 2014

2

Vermont bills on chemicals of high concern

• S.239, An act relating to the regulation of toxic substances– Department of Health to identify and publish a list of chemicals of high

concern– Manufacturer notification and replacement of chemicals

• H.744, An act relating to the regulation of toxic substances– Toxic chemical identification and reduction program– Secretary of Natural Resources would be authorized to designate a

chemical of high concern as a priority chemical– Children’s products containing a priority chemical would be prohibited

from sale

3

Connecticut bills on chemicals of concern

• HB 5036, An Act Concerning Children’s products and chemicals of high concern

• SB 126, An Act Concerning Children’s exposure to chemicals• Commissioner of Public Health to identify chemicals of high concern

to children• The list would include chemicals that meet

the following criteria:– Biomonitoring studies– Chemicals found to be present in household – Chemicals listed in other states

4

Massachusetts bill on chemicals of concern

• HB 235, An Act for healthy families and businesses• Would require recommendations for chemical substances to be

designated as priority chemical substances, and comments relative to chemical action plans, safer alternatives assessment report and creation of a chemical list

• The list would rely on other published authoritative lists• The bill would reduce the presence of priority chemical substances

in consumer products and the workplace by promoting safer alternatives to such substances

5

Oregon bill on high priority chemicals

• SB 1569 A Bill for an Act Relating to high priority chemicals of concern for children’s health

• The bill would require the Oregon Health Authority to establish and maintain a list of designated high priority chemicals of concern for children's health used in children's products

• The bill would also require manufacturers of certain children's products to provide notice to the Authority regarding chemicals on the list

6

Idaho Resolution on chemicals of concern

• Idaho's Legislature issued a Concurrent Resolution encouraging companies to avoid substances likely to be harmful and substitute safer alternatives whenever feasible in household products, especially those likely to be used by pregnant women and children

• The Resolution defines those substances to include phthalates, mercury, perfluorinated compounds, bisphenol A (BPA) and the flame retardant tetrabromobisphenol A

• It commends those Idaho companies voluntarily disclosing, reducing or avoiding entirely substances likely to be harmful

7

New York bills to restrict chemicals in children's products

• A 626, Creates the toxics information clearinghouse– Publicly-accessible website, to list substances hazardous to public

health, safety or the environment that have been identified or listed as a hazardous waste in regulations

• A 6328/S 4614, Relates to regulation of toxic chemicals in children's products – Prohibit the distribution, sale or offer of a children's product containing a

priority chemical that has been listed for at least one year

8

Washington Toxics Coalition report

• The Washington Toxics Coalition issued a report summarizing manufacturers' reports to the state’s Department of Ecology– There were 4,605 reports of Chemicals of High Concern to Children– A total of 78 companies reported products containing harmful chemicals– A total of 49 chemicals were reported including

formaldehyde, bisphenol A, parabens, phthalates, heavy metals, and industrial solvents

9

New EU toy standard

• EN 71-13:2014, Safety of toys - Part 13: Olfactory board games, cosmetic kits and gustative games.

• Specifies requirements on the use of substances and mixtures and in some cases on their amounts and concentrations

• These substances and mixtures are:– those classified as dangerous by the EC-legislation applying to

dangerous substances, and dangerous mixtures;– substances and mixtures which in excessive amounts could harm the

health of the children using them and which are not classified as dangerous by the above mentioned legislation; and

– any other chemical substance(s) and mixture(s) delivered with the set.

• Specifies allergenic fragrances which are prohibited in toys

10

EU votes to establish new toy restrictions

• European Commission (EC) has voted in favor of establishing new chemical restrictions for toys

• The proposals would establish limits of:– mg/l of BPA, in accordance with EN 71-10:2005 and EN 71-11:2005;– 5 ppm (content limit) each of TCEP, TCPP and TDCP

• Toys intended for use by children under 36 months or in other toys intended to be placed in the mouth

• Nickel classified as "CMR 2“• Restriction on its use to toys and toy components made of stainless

steel or toy components which are intended to conduct an electric current

11

Arizona considers restrictions on BPA

• SB 1376, Relating to Products Containing Bisphenol A• The bill would prohibit the sale or distribution of any "child container"

that contains BPA, starting 1 January 2016• “Child container" to mean an empty baby bottle or spill proof cup

that the manufacturer intends to be used primarily by a person who is five years of age or less

• The bill would also require manufacturers

to use "the least toxic alternative" when

replacing BPA

12

State bills on BPA in food and beverage containers

• New Jersey, Kentucky and Nebraska are considering bills on Bisphenol A in reusable food or beverages containers

• The bills would prohibit the sale, offer or distribution of food or beverage storage containers made with or composed of BPA

• The Nebraska bill would also prohibit manufacturers replacing BPA with any substance containing carcinogens rated by the United States (US) Environmental Protection Agency (EPA) as Group A, B, or C carcinogens or substances listed on the agency's Office of Pesticide Programs List of Chemicals Evaluated for Carcinogenic Potential as known or likely carcinogens, known to be human carcinogens, likely to be human carcinogens, or suggestive of being carcinogens

13

Wisconsin Assembly re-introduces BPA amendment

• The Wisconsin assembly has re-introduced AB 607, a bill originally introduced in 2013

• Current law prohibits the manufacture or sale of any "child's container" containing bisphenol A and requires labeling of such containers to indicate they do not contain BPA

• The bill would expand this law to include "food containers"

14

Germany’s BfR updates its BPA FAQ

• The German Federal Institute for Risk Assessment (BfR) has updated its frequently-asked-questions on bisphenol A

• The FAQ addresses questions such as:– What are the effects of BPA?– When is the final opinion of the European Food Safety Authority

(EFSA)?– Are there alternatives to polycarbonate baby bottles?– Can internal coatings of food and beverage cans contain BPA?

15

RAC delivers 16 CLH opinions, including BPA

• The European Chemicals Agency's (ECHA) Committee for Risk Assessment (RAC) has adopted 16 new opinions for harmonized classification and labeling (CLH) of 16 chemicals, including, but not limited to:– Bisphenol A (BPA)– Direct blue FC 57087– Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC)

16

New York bill on BPA and phthalates

• The bill would prohibit any toy or child care product containing bisphenol A, intended for use of a child under 14 years of age

• It would also restrict any toy or child care product containing any individual phthalate or multiple phthalates in concentrations in excess of 0.1%

• It would restrict products containing any individual phthalate or multiple phthalates in concentrations in excess of 0.1%, intended for use by a child under 14 years of age, when such a toy or product may be placed in the child’s mouth

• Phthalates means DEHP, DBP, BBP, DINP, DIDP or DNOP

17

New York State considers BPA restrictions

• A6107 would prohibit sales or offering of liquids, foods and beverages in containers, for children 3 or younger, containing BPA. The bill would also prohibit the sale or offering of toys containing BPA

• A5883 would prohibit the manufacture, distribution, sale or offer for sale of any hot beverage lid product containing BPA

• A5978, would prohibit the sale or offer for sale

of any liquid, food or beverage in a can, jar or

other container containing BPA

18

New Jersey urges Congress to prohibit phthalates and BPA

• New Jersey's Assembly issued a Resolution urging Congress to enact legislation banning phthalates and bisphenol A (BPA) in children’s products

• The Resolution states:– A number of states have banned, or introduced legislation banning, the

sale, manufacturing, and distribution of toys, child care articles, baby bottles, and food containers made with phthalates or BPA, but federal legislation is needed to create a national standard for manufacturers, retailers, and other distributors in order to respect interstate commerce and nationally promote safer children’s products.

19

New Jersey bill on heavy metals in children’s products

• A626, which would prohibit the sale, offer, distribution, import or manufacture of any children’s product for use by a child under the age of six containing, composed of or made with lead, mercury or cadmium

• “Children’s product” means a product, including a toy or play equipment, that is designed or intended solely or primarily for the care of, or use by, a child; or to come into contact with a child while the product is used

20

Hawaii bill on BPA and phthalates in toys and child care articles

• S.B. No. 2573, to prohibit the manufacture, sale or distribution of certain toys and child care articles

• The bill would prohibit any toy or child care article that is:– Intended for use by a child under three years of age and contains

bisphenol A – Contains di-2-ethyl hexyl phthalate, di-n-butyl phthalate, or butyl benzyl

phthalate in concentrations exceeding 0.1%; – Intended for use by a child under three years of age, is small enough to

be placed in a child's mouth, and contains diisononyl phthalate, diisodecyl phthalate, or di-n-octyl phthalate in concentrations exceeding 0.1%

21

Mississippi bill on cadmium, lead and phthalates

• Mississippi's Legislature is considering a bill which would restrict children's products or product component containing:– lead at more than .009% by weight (90 ppm), except as provided;– cadmium at more than .004% by weight (40 ppm); or– phthalates, individually or in combination, at more than 0.10% by weight

(1,000 ppm).

• The bill provides for a lower limit of .004% by weight (40 ppm) of lead, if it’s determine it's feasible

• It applies to products such as toys, children’s cosmetics, children’s jewelry, and child car seats

22

New York phthalate bill

• A 5925, Prohibits the manufacture, distribution and sale of toys and child care products containing phthalates

• The bill would prohibit the manufacture, distribution, sale or offer for sale of any toy or child care product containing di-isononyl phthalate, di-iso-decyl phthalate or di-n-octyl phthalate in concentrations in excess of 0.1%, intended for use by a child under three years of age when such toy or product may be placed in the child's mouth

23

New Jersey bill on phthalates in jewelry

• The bill would prohibit the sale, offer for sale at retail, distribution, import or manufacture of any jewelry containing, composed of or made with any phthalates

• The bill would also require any manufacturer, distributor, or importer of jewelry, who discovers that the jewelry contains, is composed of, or is made with any phthalates, shall issue an immediate recall for that jewelry

• “Phthalates" means DEHP, DBP, BBP, DINP, DIDP, DNOP or DnOP and any other phthalate, as determined

24

US Senate considers expanded phthalates restrictions

• S.2120, To expand the prohibition on the manufacture, distribution, and importation of children's products that contain phthalates, and for other purposes

• The bill, introduced by Senator Kirsten E. Gillibrand (D-NY), would amend the Consumer Product Safety Improvement Act of 2008 to expand CPSIA's restrictions on phthalates to include diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DnOP), each of which would be limited to 0.1%

• These restrictions would apply to "children's products," rather than to "children's toys or child care articles."

25

Phthalates under scrutiny in Maine

• The Alliance for a Clean and Healthy Maine has issued a report, “Hormones Disrupted: Toxic Phthalates in Maine People,”

• Results showed that every one of the 25 men and women who voluntarily participated had detectable levels of phthalates in their bodies

• The report recommends designating phthalates as Priority Chemicals under the Kid-Safe Products Act and requiring manufacturers to publicly report which of their products contain specific phthalates

• The report also recommends the use of phthalates should be phased out in favor of safer alternatives

26

Danish Phthalates guidance document

• The Danish Environmental Protection Agency and a number of industry associations have issued a guidance document on limiting phthalates of concern in articles

• Phthalates of concern are the phthalates identified as Candidate Substances of Very High Concern under the REACH Regulation

• The guidance is designed to support businesses in checking whether they buy articles with phthalates of concern

27

Hong Kong’s 'Additional Safety Standards' for toys

• L.N. 17 of 2014, Toys and Children's Products Safety (Additional Safety Standards or Requirements) Regulation

• The total weight of Class 1 phthalates, defined to include BBP, DBP and DEHP, must not exceed 0.1% of the total weight of the plasticized material in the toy or children's products

• The total weight of Class 2 phthalates, defined to include DIDP, DINP and DNOP, must not exceed 0.1% of the total weight of plasticized materials in the toy or children's products

• The Regulation also establishes restrictions on phthalates in toys or children's products capable of being partly placed into the mouth of a child under four years of age

28

RoHS2 Final Report

• Environment Agency Austria (Umweltbundesamt GmbH) has issued its Final Report on the “Study for the Review of the List of Restricted Substances under RoHS 2 Directive."

• Eight substances were identified as "highest priority," including: – phthalates, DEHP, DBP, BBP and DiBP;– chlorinated flame retardant, tris(2-chloroethyl)phosphate;– brominated flame retardants, Hexabromocyclododecane (HBCDD) and

2,3-dibromo-1-propanol; and– Dibromoneopentyl-glycol.

29

Maryland bill on flame retardants

• HB 229, to prohibit the import, sale or offer of certain children’s products containing certain flame retardant chemicals

• “Child care products,” means consumer products intended for use by a child under the age of three, including a baby product, toy, car seat, nursing pillow, crib mattress and stroller

• The bill would prohibit the import, sale or offer of any child care product that:– Contains more than 1/10 of 1% of tris(2-chloroethyl) phosphate (TCEP)

or tris(1,3-dichloro-2-propyl) phosphate (TDCPP) by mass and– Is intended for use by a child under three

30

 Connecticut bill on flame retardants

• HB 5035 would prohibit chlorinated flame retardants in children's products

• “Children's product" means any product designed or intended primarily for use by children three years of age or younger, including, but not limited to, clothing, toys, nursing pillows, crib mattresses, changing pads, strollers and car seats

• The bills would prohibit the manufacture, sale, offer for sale or distribution of any children's product containing tris (1,3-dichloro-2-propyl) phosphate (TDCPP or TDCP), tris (2-chloroethyl) phosphate (TCEP) or tris (1-chloro-2-propyl) phosphate (TCPP), except for such products governed by federal motor vehicle standards contained in 49 CFR 571.302

31

Alaska bills on flame retardants

• Both Alaska’s House and Senate are considering bills on flame retardants

• The bill would identify and list chemicals of high concern for childhood exposure

• The bill would also prohibit the manufacture in the state, sale in the state, offer for sale in the state, or distribution for sale in the state of a consumer product that contains:– TDCPP (Tris (1,3-dichloro-2-propyl) phosphate); – TCEP (Tris (2-chloroethyl) phosphate); or– TCPP (Tris (1-chloro-2-propyl) phosphate).

32

New York considers expanding its TRIS-free children and babies act

• New York's Senate has reintroduced two bills, SB 3703A and 3703B, to expand the state's TRIS-free children and babies act

• The bills would expand the definition of "TRIS" to include TCEP (Tris (2-chloroethyl) phosphate) and TDCPP (Tris (1,3-dichloro-2-propyl) phosphate), starting 1 December 2015

• The bills, originally introduced in 2013, were both recently referred to Environmental Conservation

33

 Washington State bills on flame retardants

• The Washington State Legislature is considering two bills to restrict the sale, offer or distribution of residential upholstered furniture or children’s products

• The bills defines TRIS to mean either TDCPP (tris(1,3-dichloro-2-propyl)phosphate) or TCEP (tris(2-chloroethyl) phosphate).

• The bills would restrict the sale, offer or distribution of residential upholstered furniture or children’s products containing a flame retardant identified as a high priority chemical of high concern for children in amounts exceeding 50 ppm

34

US EPA issues final alternatives assessment for DecaBDE

• The Environmental Protection Agency's (EPA) Design for the Environment (DfE) program issued final report on an alternatives assessment for decabromodiphenyl ether (decaBDE)

• The report provides detailed hazard information for 29 substances and mixtures that have been identified as potentially viable alternatives to decaBDE in a variety of polymers and applications

• Efficacy of the flame retardant alternatives was not tested

35

CEH reports on TDCPP, TCEP and TDBPP

• The Center for Environmental Health (CEH) has reported on its "landmark legal agreements" to remove flame retardants from foam furniture and children's products, as per California Proposition 65

• The report references the recent Prop 65 settlements, which relate to the chemicals TDCPP, TCEP and TDBPP

• The report includes a chart of all of the products and brands that have agreed to remove the chemicals from their products, as well as those who have not

• The organization indicates it will issue future "progress reports" on each company

36

California DTSC announces ‘priority products’

• California's Department of Toxic Substances Control (DTSC) has announced its first three draft "priority products" under the state's Safer Consumer Products Regulations:– Children's foam padded sleeping products containing TDCPP– Spray Polyurethane foam systems containing unreacted diisocyanates.

used for home and building insulation, weatherization, sealing and roofing

– Paint stripper containing Methylene Chloride

• The Priority Products won't be final until a rulemaking process is complete, adopting regulations to list the products, which could take up to a year

37

Japan's considers new flame retardants restrictions

• Japan's Ministry of Economy, Trade and Industry (METI) is considering an amendment to its Chemical Substances Control Law, to establish new restrictions on the following flame retardant chemicals:– hexabromocyclododecane (HBCD) and– Endosulfan

• The comment period ended in February

38

State bills on formaldehyde

• Illinois, New York, Iowa and South Carolina are considering bills on formaldehyde

• The bills would prohibit any manufacturer, wholesaler or retailer from selling or offering for sale a children's product that intentionally contains: – formaldehyde, including formaldehyde contained in a solution, or – ingredients that chemically degrade under normal conditions of

temperature and pressure to release formaldehyde

39

AAFA comments on formaldehyde

• The American Apparel & Footwear Association (AAFA) and several other associations submitted comments to the Maine Department of Environmental Protection (DEP) on the regulation of formaldehyde in children's products

• DEP proposed adding formaldehyde, arsenic, mercury and cadmium to its list of Priority Chemicals under the Maine Toxic Chemicals in Children's Products Law

• The comments submitted by AAFA and the other associations oppose the proposal to designate formaldehyde as a Priority Chemical

40

 Paraguay drafts on textile products

• Paraguay's Ministry of Industry and Trade (MIC) has published two Draft Technical Regulations on textile products

• The Draft Regulations would establish the following limits on lead and formaldehyde in apparel:– apparel and home textiles: 120 ppm, otherwise, the apparel must bear

the words "Wash before use"– baby apparel: 20 ppm– baby accessories: 90 ppm

• The second Draft Regulation deals with labeling requirements

41

EEC considers restrictions on formaldehyde in furniture

• The Eurasian Economic Commission (EEC) held a meeting to assess the limit for formaldehyde in furniture products

• Participants of the meeting agreed not to change the existing standard for formaldehyde furniture products, 0.01 mg/m³.

• They determined it is scientifically sound and consistent with international norms

42

California proposed amendments on formaldehyde

• The California Air Resources Board (ARB) is considering proposed amendments to its Airborne Toxic Control Measure (ATCM) to Reduce Formaldehyde in Composite Wood Products on certification and labeling of laminated products

• The amendments are intended to improve the ATCM and to further align the ATCM with proposed federal Environmental Protection Agency (EPA) regulations

43

EPA announces a workshop on formaldehyde

• The United States (US) Environmental Protection Agency (EPA) is currently revising its Integrated Risk Information System (IRIS) assessment of formaldehyde

• This assessment addresses both non-cancer and cancer human health effects that may result from chronic inhalation exposure to this chemical.

• A workshop will be open to the public, broadcast by webinar• It is tentatively scheduled to take place 29-30 April 2014

44

New York bill on cadmium in novelty products

• S 6729, An act to amend the environmental conservation law, in relation to cadmium-added novelty consumer products

• The bill would prohibit the sale, offer for sale or distribution for free of any cadmium-added novelty consumer product, starting 1 June 2015

• “Cadmium-added novelty products" means products intended mainly for personal use or adornment that contain cadmium in excess of .0075% by weight

45

 Connecticut considers adoption of children's

jewelry standard

• The Bill would restrict children's jewelry that contains cadmium at more than .0075% by weight, that exceeds the level set forth in ASTM F2923:2011, Specification for Consumer Product Safety for Children's Jewelry, on and after 1 July 2014

• The bill defines "children's jewelry" to mean any jewelry, including charms, bracelets, pendants, necklaces, earrings or rings, and any component thereof, that is designed or intended to be worn or used by children twelve years of age or younger

46

New York bills on hazardous toys

• A 5824/S 845 would prohibit the import, manufacture, sale, holding for sale or distribution of any toy or article intended for use by a child which presents an electrical, mechanical or thermal hazard or that is contaminated with any toxic substances

• A toy is contaminated with a toxic substance if it is:– coated with paints and lacquers containing compounds of lead in which

the lead content (calculated as Pb) is in excess of that permitted by 16 CFR 1500, or soluble compounds of antimony, arsenic, cadmium, mercury, selenium or barium, introduced as such

47

New York reintroduces bill to restrict lead in jewelry

• The bill, SB 1576-A, would restrict jewelry, unless it’s made entirely from a Class 1, Class 2 or Class 3 material or any combination thereof

• The bill would also restrict children's jewelry, unless it’s made entirely from one or more of the following:– a nonmetallic material that is a Class 1 or Class 2 material– a metallic material that is either a Class 1 material or contains less than

600 ppm lead by weight– glass or crystal decorative components that weigh in total no more than

one gram, excluding any glass or crystal decorative component that contains less than 200 ppm lead by weight and has no intentionally added lead;

– printing ink or ceramic glaze that contains less than 600 ppm lead by weight; or

– Class 3 material that contains less than 200 ppm lead by weight

48

Philippine lead limits

• The Philippine Department of Environment and Natural Resources (DENR) has issued a chemical control order (CCO) for lead and lead compounds

• The Order prohibits the use of lead and lead compounds in the local manufacture of packaging for food and drink, toys, school supplies, cosmetics, water pipes and other consumer products

• It also restricts lead in locally-produced paints, with a limit of 90 ppm• This new limit takes effect in 2016 for paints intended for

architectural, decorative, household applications

49

IPEN reports on lead in paint in Asia

• The International POPs Elimination Network (IPEN) has released a new report on lead levels in paints in seven Asian countries

• IPEN found that majority of household paints analyzed in seven Asian countries contain unsafe levels of lead

• The levels would not meet regulatory standards established in most highly industrialized countries; and, in a number of cases, have “astonishingly” high lead content

50

ECHA opinions on lead, phthalates and trichloroethylene

• The European Chemicals Agency's (ECHA) Committee for Socio-economic Analysis (SEAC) adopted an opinion on the restriction proposal of lead in consumer articles submitted by Sweden, confirming its draft opinion of December 2013

• RAC agreed on draft opinions for four uses and SEAC on draft opinions for two uses. RAC and SEAC will discuss the remaining uses of DEHP and DBP in June 2014

• RAC made progress with developing dose-response relationships for the carcinogenicity of trichloroethylene

51

Indonesia restricts heavy metals in baby clothes

• The Indonesian Minister of Industry has published a Technical Regulation establishing restrictions on heavy metals in textiles for baby clothes, as follows:– Cadmium (Cd): 0.1 ppm– Copper (Cu): 25 ppm– Lead (Pb): 0.2 ppm– Nickel (Ni): 1 ppm

• The Regulation requires fabrics to comply with the Indonesian national standard, SNI 7617:2013, Textiles – Requirements for azo dyes and formaldehyde content in fabrics for baby and children’s clothing

52

Denmark promotes eco-friendly textile production

• Denmark's Environmental Protection Agency has announced a new pilot project on a partnership with Danish companies and other players in the textile sector to promote use of organic cotton and lower chemical consumption in textile production

• The project includes 28 players, from carpet and clothing companies to design schools and industry associations

• The partnership is expected to be operational during 2014 and the EPA plans to hold a workshop with stakeholders before the summer recess

53

Norway proposes delay on PFOA restrictions

• Following its announcement in March that it was recommending a delay to the restrictions on perfluorooctanoic acid (PFOA) in textiles, the Norwegian Environment Directorate is inviting stakeholders to take part in a consultation on the proposed delay.

• The draft amendment to the Product Regulation would permit the placing on the market of non-compliant stock manufactured before 1 June 2014 until 1 January 2018

• Comments can be submitted via the Environment Directorate's website until 9 May 2014

54

ACCC testing prompts clothing recalls

• The Australian Competition and Consumer Commission’s (ACCC) recalled of four pairs of jeans and one pillow case for having unacceptable concentrations of certain azodyes containing unacceptable concentration of aromatic amines

• While azodyes are not banned for textiles use in Australia, if the ACCC identifies safety concerns it can recommend suppliers recall unsafe goods

• ACCC's press release encourages suppliers to ensure that the total maximum level of hazardous aromatic amines in direct and prolonged contact with the skin be no more than 30 ppm

55

EC restricts Chromium VI in leather articles

• Regulation (EU) No 301/2014 amends Annex XVII of REACH to establish new restrictions, as follows:– leather articles coming into contact with the skin containing chromium VI

in concentrations equal to or greater than 3 mg/kg (0.0003% by weight) of the total dry weight of the leather; and

– articles containing leather parts coming into contact with the skin where any of those leather parts contains chromium VI in concentrations equal to or greater than 3 mg/kg (0.0003% by weight) of the total dry weight of that leather part. 

• The Regulation takes effect on 1 May 2015

56

PAHs found in footwear

• Hong Kong's Consumer Council tested plastic footwear for children and found that more than half the samples contained high levels of harmful chemicals:– In a test of 28 pairs of casual footwear, a carcinogenic polycyclic

aromatic hydrocarbon (PAH) benzopyrene was found in three brands. Tests showed they contained 1.1-3.1 ppm of the chemical.

– Fifteen samples, including all six pairs of rubber boots tested, contained phthalates at many times higher than 0.1%. In 12 samples, levels ranged from 15.2-43.43%.

• The Consumer Council recommended the government expand the coverage of its Toys and Children's Products Safety Regulation to include footwear

57

Proposed duty on products containing restricted substances

• The Swedish Chemicals Agency (KEMI) is considering an excise duty on consumer products – such as clothing and footwear – that contain hazardous substances

• The tax would be high enough to have a “controlling effect,” estimating that the average price increase for clothing and footwear would be 0.3%

• The tax would not apply to goods containing

prohibited or restricted hazardous substances

that already breach the law

58

KEMI issues report on its 'Action Plan for toxic-free living'

• Sweden's Chemicals Agency (KEMI) issued an interim report on its "Action plan for toxic-free living."

• KEMI reports that it has continued to increase its inspections and tests of children's products in 2013

• The agency points to toys and electronics as the categories in which they find the most violations, with 15% of toys and 12% of electronics out of compliance

• KEMI has been tasked with reporting, by 16 June 2014, on how the Action Plan can be further developed for the period 2015–2020

59

ECHA proposes four new SVCHs

• The European Chemicals Agency (ECHA) has proposed an additional four chemicals as substances of very high concern (SVHCs):– 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear;– Cadmium chloride;– Sodium perborate; perboric acid, sodium salt; and– Sodium peroxometaborate.

• Three substances are classified as toxic for reproduction and one is proposed because of its endocrine disrupting properties and potential for serious effects to the environment

60

Greenpeace report on chemicals in luxury children's clothing

• Greenpeace International has issued a report, A Little Story about a Fashionable Lie: Hazardous chemicals in luxury branded clothing for children

• Greenpeace sent 27 children's clothing products to independent laboratories, to be tested for the presence of nonylphenol ethoxylates (NPEs), phthalates, per- and polyfluorinated chemicals (PFCs) and/ or antimony

• Sixteen of the products tested positive for one or more of these hazardous chemicals.

61

Taiwan amends Food Safety Act

• Taiwan's national legislature has approved amendments to its renamed Food Safety and Sanitation Regulation Act

• Article 16 will include a clause that food contact articles utensils, food containers or packaging or food cleansers cannot be made of materials that present risks to health

62

OEHHA intent to list nitrite in combination with amines or amides

• On 7 February 2014, California's Office of Environmental Health Hazard Assessment (OEHHA) published a notice in the California Regulatory Notice Register announcing its intent to list nitrite in combination with amines or amides as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)

• OEHHA extended the public comment period until 8 May 2014

63

Turkey proposes amendment for aluminum in food contact

• Turkey's Ministry of Food, Agriculture and Livestock has notified the of a proposed Regulation Amending Turkish Food Codex Regulation on Materials and Articles in Contact with Food

• The purpose is to determine the rules for chemical recycling of plastics that are in contact with food and setting a release limit and labelling rules for aluminum which are in contact with food

• The proposed date for adoption is 30 April 2014

64

Possible amendments to EU ceramicware Directive

• The European Commission (EC) is considering amending its Directive 84/500/EEC, which restricts lead and cadmium in ceramic articles intended to come into contact with foodstuffs

• Discussions on the scope of the Directive; legal limits of lead, cadmium and additional metals and test conditions for checking compliance of such materials and articles are taking place with different stakeholders

• The Joint Research Centre (JRC) of the Institute for Health and Consumer Protection (IHCP) will provide data on what metals migrate from ceramic tableware and how much migrates.

65

EFSA opinion on post-consumer PET

• The European Food safety Authority (EFSA) has issued a Scientific Opinion on its safety assessment of the "Aliplast Buhler B" process used to recycled post-consumer polyethylene terephthalate (PET) into food contact materials

• The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that recycled PET obtained from the process, intended to be used up to 100% for the manufacture of materials and articles for contact with all types

of foodstuffs for long term storage at room

temperature, with or without hotfill, is not

considered of safety concern

66

EU Ozone Depleting Substances Quotas

• The quantities of controlled substances subject to Regulation (EC) No 1005/2009 which may be released for free circulation in the Union in 2014 were published in Commission Implementing Decision of 18 December 2013 (2013/808/EU)

• The allocation of quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 and other fully halogenated chlorofluorocarbons during the period 1 January to 31 December 2014 are indicated in Annex I

• The Decision applies from 1 January 2014 and expires on 31 December 2014

67

EU Regulation on PFOS and Chlorate

• The European Commission (EC) has issued Regulation (EU) No 167/2014, to amend Regulation (EC) No 689/2008, concerning the export and import of dangerous chemicals

• The Regulation establishes new use limitations for Didecyldimethylammonium chloride, Perfluorooctane sulfonates (PFOS) and Chlorate

68

 OEHHA draft proposed Reference Exposure Levels

for benzene

• California's Office of Environmental Health Hazard Assessment (OEHHA) has issued a draft document, “Proposed Reference Exposure Levels (RELs) for benzene”

• Proposed values for the acute, 8 hour, and chronic RELs are 27 µg/m3 (8 ppb), 3 µg/m³ (1 ppb) and 3 µg/m³ (1 ppb) respectively

• When finalized and adopted, these RELs will be added to the compound-specific toxicity reviews and summary tables which appear as appendices to the Technical Support Document for the Derivation of Noncancer Reference Exposure Levels

69

South Korea draft decrees under K-REACH

• South Korea's Ministry of Environment is considering two draft Decrees under the Act on the Registration and Evaluation of Chemical Substances (K-REACH)

• The draft Presidential Decree would clarify:– existing substance registration requirements for manufacturers and

importers;– which substances will be exempt from registration; and– which substances will qualify for simplified registration or be exempt

from registration.

• The draft Ministerial Decree would clarify:– registration periods for new substances;– detailed registration data requirements; and– requirements for joint submission and use of data

70

K-REACH Help Desk

• South Korea's Ministry of Environment (MoE) has opened K-REACH Help Desk

• The Help Desk was established to support the execution of K-REACH nationally and internationally

• Its services include:– Provision and promotion of K-REACH-related data and training;– K-REACH execution assistance counseling and– Collection of opinions from stakeholders concerned with K-REACH

• The URL is: http://www.kreach.or.kr/

71

South Korean chemical registration

• South Korea's Ministry of Environment has notified of an Enforcement Decree and an Enforcement Rule on chemical substances

• The Decree and Rule center on mandatory registration for existing chemicals manufactured in or imported to Korea over 1 ton per year and/ or new chemicals

• The purpose is to protect public health and the environment by providing for the matters pertaining to the registration of chemical substances, the examination and evaluation of hazards and risks of products containing chemical substances and hazardous chemical substances, and the designation of hazardous chemical substances, and by producing and utilizing information on chemical substances

72

New & updated alternative test methods under REACH

• The European Commission has issued Commission Regulation (EU) No 260/2014 to amend Regulation (EC) No 440/2008, which lays down test methods under the REACH Regulation

• The amendment issues:– two methods for the determination of physicochemical properties – four new and one updated method for the determination of ecotoxicity

and environmental fate and behavior; – nine methods for the determination of toxicity and other health effects

including four inhalation toxicity test methods

73

New guidance on REACH substance evaluations

• The European Chemicals Agency issued a new guidance document, Substance evaluation under REACH: Tips for registrants and downstream users

• This publication provides advice for registrants who hold a registration for a substance included in the Community Rolling Action Plan and for downstream users of such substances on how to participate in the substance evaluation process

74

ECHA revises Consultation Procedure for Guidance

• The European Chemicals Agency (ECHA) has published a second revision of its Consultation Procedure for Guidance

• The Guidance describes how ECHA consults relevant partners on the Guidance it generates and publishes to support the implementation of legislation within its remit

• The updated procedure document now takes full account of the extension of ECHA's guidance activities to include the Biocidal Products Regulation (BPR) and the Prior Informed Consent (PIC) Regulation as well as the REACH and CLP Regulations which were covered by the previous revision

75

ECHA updated the C&L Inventory

• The European Chemicals Agency (ECHA) has updated its Classification & Labelling (C&L) Inventory

• The Inventory contains C&L information on substances notified under the CLP Regulation and registered under REACH

• Updates include:– Flags for notified substances where an impurity or an additive present in

the substance impacts the notified classification– Ability to include additional CAS numbers in the column "Additional

Notified Information"– Publicly available IUPAC names, as well as the notified physical

state/form of the substance for all notifications are now reported under the "Additional Notified Information" column

76

New EU hazardous chemical rules

• From 1 March 2014, new rules concerning the export and import of very hazardous chemicals will be implemented in the European Union (EU), when the revised Prior Informed Consent (PIC) Regulation becomes operational

• PIC regulates the import and export of very hazardous chemicals between the European Union and third countries, and implements the global Rotterdam Convention within the EU

• The new regulation is consistent with the REACH and Classification, Labelling and Packaging (CLP) regulations

77

EurAsEC announces public discussion of draft technical regulations

• Technical Regulations "On Restriction of Hazardous Substances in Electrical and electronics products" establishes requirements for limiting the use of hazardous substances in electrical engineering and electronics products

• In accordance with the Regulations on the development, adoption, amendment and cancellation of the technical regulations of the Customs Union set period of public discussion of draft technical regulations - not less than 60 calendar days from the date of posting notices on their development on the official website of the ECE

78

ECHA recommendations on nanomaterials

• The European Chemicals Agency (ECHA) has published generic recommendations for the exposure assessment and risk characterisation of nanomaterials under REACH

• The document is based on the outcome of the last Group Assessing Already Registered Nanomaterials (GAARN) meeting, which was held on 30 September 2013

• The GAARN discussed assessing and managing the safety of nanomaterials under the REACH Regulation

• ECHA reminds the registrants that dossiers need to be updated with new nano-specific studies as scientific knowledge is progressing

79

US & Canada developing harmonized nano classification scheme

• The United States (US) and Canada are working to harmonize their regulatory approaches to nanomaterials, developing a classification scheme based on similarities in chemical composition

• The effort, led by the US Environmental Protection Agency (EPA) and Environment Canada and Health Canada, has issued draft reports under the US-Canada Regulatory Cooperation Council (RCC) Nanotechnology Initiative

80

IC2 issues its Alternatives Assessment Guide

• The Interstate Chemicals Clearinghouse (IC2) has issued its Alternatives Assessment Guide

• The Guide was created to:– Foster replacement of toxic chemicals in products by selecting less

hazardous, safer alternatives – Include all reasonable criteria to be addressed in an AA including

hazard, exposure, performance, cost, and availability– Recommend the minimum data set needed to conduct an AA

• Eight IC2 member states, including California, Connecticut, Massachusetts, Michigan, Minnesota, New York, Oregon and Washington, worked together on the Guide

81

Manufacturing coalition announces alternatives assessment principles

• The Cleaning Institute unveiled a set of principles to help establish an effective program for assessing chemicals in consumer products and identifying possible alternatives

• The coalition includes the American Chemistry Council (ACC), the Personal Care Products Council (PCPC) and the Toy Industry Association, Inc. (TIA)

• The principles are designed to:– Ensure consumer acceptance– Be flexible and modular – Be effective and feasible– Protect confidential business information– Allow for gradual evaluation and implementation of alternatives– Avoid duplicative efforts

82

OEHHA issued its 2014 Report to the Legislature

• California’s Office of Environmental Health Hazard Assessment (OEHHA) has issued its 2014 Report to the Legislature, summarizing its efforts under the Environmental Health Program

• The Report summarizes information from recent studies on the status of children’s health as well as effects of environmental contaminants on California’s children

• It focuses on four areas of health and development that can be impacted by environmental contaminants: asthma and respiratory disease, adverse birth outcomes, neurodevelopment, and cancer

83

California considers revisions to Prop 65 warnings

• California's Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of a public workshop to discuss possible regulatory action to change the existing regulation governing Proposition 65 warnings

• The intent is to make the warnings more informative and meaningful while providing certainty for businesses on the content and methods for providing warnings

• A potential draft regulation and a potential draft Initial Statement of Reasons are available for public review on OEHHA’s Web site

• The workshop took place in April

84

California Assembly considers Prop 65 reform

• A bill to reform Proposition 65 enforcement that would increase the number of employees necessary before companies fall under the jurisdiction of the statute has been introduced in the California Assembly

• The proposed legislation would increase the number of employees from 10 to 25 for a business or organization to be subject to Proposition 65 enforcement

• It would also prevent penalties from being assessed by both private enforcers and public prosecutors for the same violation

85

US House considers TSCA reform 'Discussion Draft'

• The United States (US) House of Representatives' Energy & Commerce Committee is considering a "Discussion Draft" of a bill, "Chemicals in Commerce Act.”

• The bill would amend the Toxic Substances Control Act (TSCA)• It would establish requirements for testing of chemical substances

and mixtures• Manufacturers and processors would be required to:

– develop new hazard and exposure information related to a chemical substance or mixture in accordance with this section if the information is needed to perform a safety determination or to ensure compliance with a federal rule.

– submit a notice of intent not later than 90 days before manufacturing or processing begins of new chemical substances or chemical substances intended for a new use

86

Illinois issues Resolution on TSCA reform

• The Illinois General Assembly issued a Resolution, HR 886, to support the efforts of the National Black Caucus of State Legislators in their efforts to modernize the Federal Toxic Substances Control Act of 1976 (TSCA) by strengthening chemical management through policy reforms.

• The Resolution also urges the state Governor and General Assembly to strengthen Illinois' chemical management statutes

87

CPSC revises its supplemental definition of 'strong sensitizer'

• The Consumer Product Safety Commission (CPSC) has published a final rule revising its supplemental definition of "Strong Sensitizer" under the Federal Hazardous Substances Act (FHSA) 

• The revised definition eliminates redundancy, removes certain subjective factors, incorporates new and anticipated technology, places the criteria for classification of strong sensitizers in the order of importance, defines criteria for “severity of reaction,” and provides for the use of a weight-of-evidence approach to determine whether a substance is a strong sensitizer

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