Chemicals Quarterly

Q2 2014

Presented by Stacey Bowers, MILS 24 July 2014

1

EU limits BPA in toys

• The European Commission established a new migration limit of 0.1

mg/l for BPA in toys

• The limit applies to toys for children up to the age of 3 years and

toys intended to be placed in the mouth

• The limit was taken from EN 71-9:2005+A1:2007

2

Thailand draft on feeding bottle requirements

• Thai Food and Drug Administration notified the WTO of a Draft

Notification on feeding bottles for young children

• The Draft applies to feeding bottles and liquid milk containers for

infants and young children

• It prescribes lists of permitted and restricted materials to be used,

including heavy metals and BPA

• The Draft is based on the Japanese standard, JIS T9112

3

EFSA BPA evaluation to be completed in 2014

• The European Food Safety Authority (EFSA) will complete its

evaluation of BPA by the end of 2014

• The second part of the scientific opinion, assessing the human

health risks of the chemical was published in January 2014

• EFSA recommends the tolerable daily intake (TDI) for BPA be

lowered from 50 µg/kg bw/ day to 5 µg/kg bw/day, and be set on a

temporary basis

• EFSA asked stakeholders to provide feedback by March 2014

4

EFSA opinion on PET recycling for food contact

• The European Food Safety Authority (EFSA) published 3 new

scientific opinions on processes for the recycling of post-consumer

polyethylene terephthalate (PET) for use in food contact materials

• Three processes – SOREPET, SOREPET GR and APPE supercycle

CP –were all found to be of no safety concern when used to recycle

post-consumer PET into 100% food contact material

• For each of the processes, PET may be sourced from food contact

applications, with a maximum of 5% content from non-food grade

post-consumer PET

5

Australia/ New Zealand food packaging proposal

• Food Standards Australia/ New Zealand is considering amending

the Food Standards Code to enact new restrictions on chemicals

migrating from packaging into food

• The Proposal - P1034 – is intended to assess the public health and

safety risk of chemicals which may migrate from packaging

materials into food, and to identify and manage any risks

• The proposed length of public consultation periods was 6 weeks for

the consultation paper and assessment and 8 weeks for consultation

on the draft food regulatory measures

6

Ecuadorian food contact proposals

• The Ecuadorian Standardization Institute (INEN) has notified the

WTO of two proposals to revise its Technical Regulations on food

contact glass and aluminum

• The Draft on glass and glass-ceramics would establish permissible

limits and test methods for lead and cadmium in food contact glass

and glass-ceramics

• The Draft on metal and aluminum would establish requirements for

food contact metal and aluminum containers

7

Maine enacts implementing rules

• Maine's Department of Environmental Protection (DEP) has enacted

three proposed rules to implement the state's Toxic Chemicals in

Children's Products law:

– Chapter 884: Designation of Cadmium as a Priority Chemical;

– Chapter 886: Designation of Mercury as a Priority Chemical; and

– Chapter 887: Designation of Arsenic as a Priority Chemical

• The Rules went into force on 2 June 2014

• Additionally, DEP has indicated that its proposed rule, Chapter 885,

to designate formaldehyde as a Priority Chemical will not be

adopted

8

South Carolina considers prohibition on

formaldehyde

• The Bill, H 5101, would prohibit formaldehyde in children’s products

– Defines "child" to mean a person under 18 years of age

• The Bill would prohibit children's products that intentionally contain

formaldehyde, including formaldehyde contained in a solution, or

ingredients that chemically degrade under normal conditions of

temperature and pressure to release formaldehyde

• The Bill would take force 1 January 2015

9

Minnesota chemical bill enacted

• Minnesota enacted SF 2192

• The Bill amends the Minnesota Statutes to prohibit any cleaning

product used by consumers for sanitizing or hand and body

cleansing that contains triclosan

– The triclosan prohibition takes effect 1 January 2017

• The Bill also clarifies the state’s prohibition on formaldehyde in

children’s products

– The bill prohibits children’s products that intentionally contain

formaldehyde, including formaldehyde contained in a solution or i

intentionally added chemical ingredients that chemically degrade under

normal conditions of temperature and pressure to release free

formaldehyde at levels exceeding a de minimis level of 0.05%

– The formaldehyde prohibition takes effect 1 August 2014

10

Vermont bill on formaldehyde

• House Concurrent Resolution No. 145

requests a study and policy

recommendations concerning the health

effects of formaldehyde in children's

personal care products at levels

currently allowed by law

• The Resolution seeks to enact model

legislation which would prohibit

formaldehyde and formaldehyde

releasers from personal care products

intended for children 18 and under by

2015

11

Update on California formaldehyde emissions

regulatory process

• Over the past two years, the California Air Resources Board (ARB)

has released preliminary drafts and held workshops regarding

proposed amendments to the airborne toxic control measure

(ATCM) to reduce formaldehyde emissions from composite wood

products

• ARB emphasizes that at this stage in the process; its proposed

amendments are draft and are not finalized

• Any proposed amendments will be not be legally effective until

considered and approved by their Board and subsequent review and

approval by the California Office of Administrative Law (OAL)

12

Washington finds most children's products comply

with state laws

• Washington's Department of Ecology has released five reports describing the results of testing children's products for Chemicals of High Concern to Children

• Tests on more than 200 children’s products showed that most manufacturers are following laws that regulate the use of toxic chemicals

• The testing focused on—and found—several classes of toxic chemicals:

– Metals

– Phthalates

– Parabens

– Formaldehyde and volatile organic chemicals

• Ecology found 15 potential violations on phthalates and seven potential violations on lead or cadmium

13

Vermont restricts chemicals of high concern

to children

• Governor Peter Shumlin signed S 239 into law

• The Law lists 66 chemicals of high concern to children and provides

the authority for chemicals to be added or removed through

rulemaking

• Manufacturers who intentionally add these chemicals to their

children’s products will have to notify the Vermont Department of

Health

– Manufacturers must begin to submit disclosures biennially to the Health

Department starting 1 July 2016

• In 2017, and biennially thereafter, the Commissioner of Health will

recommend at least two chemicals of high concern to children for

consideration

14

Mexico enacts new lead restrictions

• Mexico's Ministry of Health has enacted a new mandatory standard,

NOM-004-SSA1-2013, Use of Lead Compounds in Consumer

Products

• NOM establishes limitations and sanitary specifications for the use

and marketing of domestic and/ or imported consumer products

containing lead compounds, in order to prevent adverse health

effects

• The standard applies to products including, but not limited to, paints,

coatings and inks; glazed ceramicware in contact with food; toys; art

materials; cosmetics; and furniture

• The standard references existing NOMs on lead

• The standard enters into force on 2 May 2015

15

Austrian agency finds nickel & lead in children's

jewelry

• The Austrian Federal Environment

Agency (EAA) issued a report on

chemicals in children’s jewelry

• EAA tested children's jewelry sold

by major retailers for residues of

lead and nickel

• EAA found three out of nine

products exceeded their respective

REACH limit values for nickel and

lead

16

New EU requirements for nickel in toys

• The European Commission enacted Commission Directive

2014/84/EU of to amend the New Toy Safety Directive, as regards

nickel

• The amendment added nickel to the list of substances that are

carcinogenic, mutagenic and toxic for reproduction (CMR)

– Classified nickel as a CMR 2 substance

• The amendment permits nickel in toy components intended to

conduct an electric current

• Member States must adopt and publish laws, regulations and

administrative provisions necessary to comply with the Directive by

1 July 2015

17

EU General Court rules on Germany's heavy metals

restrictions in toys

• The General Court of the European Union issued a judgment in

Case T-198/12, Germany v Commission

• The Court confirmed the European Commission's decision, by which

Germany may not maintain its current limit values for arsenic,

antimony and mercury in toys

– The Court stated that Germany has not proved that those limit values,

which correspond to the old EU standard, ensure a higher level of

protection than the new EU limit values

• The court allowed for Germany to maintain its own limit values for

lead in toys

18

ISO considers amendments to toy safety standard

• The International Organization for

Standardization (ISO) is considering

amendments to its toy safety

standard, ISO 8124-6, Safety of toys

-- Part 6: Toys and children's

products - Determination of certain

phthalate esters in toys and

children's products

• Voting ended in May 2014

19

Dossier on a possible restriction on DIBP

• The Öko Institut has published a dossier on a possible restriction

on diisobutyl phthalate (DIBP) in electrical and electronic products

• According to the dossier, the restriction is necessary to avoid

the substance being used as a replacement for three other

phthalates to be added to the RoHS 2 Directive (i.e., DEHP, BBP

and DBP)

20

Survey of phthalates in products in Sweden

• The Swedish Chemicals Agency (KEMI) has published a survey of

phthalates in articles in Sweden, addressing their uses and available

alternatives

• The survey shows that on the EU market the more hazardous, low-

molecular-weight phthalates have been replaced by less toxic, high-

molecular-weight phthalates

– Many Swedish companies have replaced DEHP with DIDP, DINP or

DPHP, or completely different plasticizers that are not phthalates

• However, on the rest of the world market, the low-molecular-weight

phthalate DEHP still dominates

21

EU restricts TCEP, TCPP & TDCP in toys

• The European Commission (EC) has issued Directive 2014/79/EU

to amend the New Toy Safety Directive, to establish restrictions on

TCEP, TCPP and TDCP in toys

• The Directive establishes a 5 ppm (content limit) of each of the three

chlorinated flame retardants

• Member States shall adopt and publish, by 21 December 2015 at

the latest, the laws, regulations and administrative provisions

necessary to comply with the Directive

22

Maryland restricts TDCCP in childcare products

• Maryland's Governor has signed a Law to expand its TRIS

restrictions to include (Tris (1, 3–dicholoro–2–propyl) phosphate)

(TDCPP) in childcare products

• The Law applies to childcare products, which are defined to mean

consumer products intended for use by a child under three, including

a baby products, toys, car seats, nursing pillows, crib

mattress and strollers

• The Law restricts childcare products that contain

more than one-tenth of 1% of TCEP or

TDCPP by mass

• The restriction takes effect 1 October 2014

23

Health Canada prohibits TCEP in children‘s

products

• Health Canada has amended the Canada Consumer Product Safety

Act (CCPSA) to establish a new prohibition on products that are

made, in whole or in part, of polyurethane foam that contains tris (2-

chloroethyl) phosphate (TCEP) and that are intended for a child

under three years of age

• Typical PUF-containing products include toys and child care

products, such as sleep positioners and nursing pillows

• The prohibition will enter into force in six months

24

New York bill on nap mats

• New York is considering a Bill, S 7265, in relation to chemicals in

nap mats

• The Bill applies to "nap mats," defined to mean any item of furniture

intended for indoor use that consist of leather, plastic, fabric or other

material that contains cotton, wool, polyurethane or other natural or

synthetic material that is placed in such item and is intended to

facilitate sleep or relaxation of a child

• It would prohibit the use of "chemical flame retardants," defined to

mean any halogenated chemical flame retardant, including, but not

limited to, TDCPP, TCPP, TPP and any phosphorous-bromine flame

retardant

25

Report on flame retardant exposure

• The scientific journal, Chemosphere, reports on flame retardant

exposure in early childhood education environments

• Researchers measured flame retardants in air and dust collected

from 40 California ECE facilities between May 2010 and May 2011

• Low levels of six polybrominated diphenyl ether (PBDE) congeners

and four non-PBDE flame retardants were present in air

– Tris phosphate, Firemaster 550 and PBDE compounds were detected in

100% of the dust samples

– BDE47, BDE99 and BDE209 comprised the majority of the PBDE mass

measured in dust

– Levels of TCEP and TDCIPP in dust were significantly higher in facilities

with napping equipment made out of foam

26

Massachusetts flame retardant bill

• Massachusetts is considering a Bill, S 2190, To protect children and

families from harmful flame retardants

• The Bill applies to "Children's products," meaning consumer

products intended, made or marketed for use by children 12 years of

age or under

• The Bill would restrict:

– children’s products or residential upholstered furniture containing TRIS

in amounts greater than 1,000 ppm in any component

– any product containing PBDEs in a concentration greater than .1% by

weight

– flame retardants other than TRIS and PBDEs identified as chemicals of

high concern in concentrations deemed to be harmful as determined by

the US EPA, the Toxics Use Reduction Institute or other authoritative

government entity

27

Kaiser Permanente Commits to Furniture Free

from Toxic Flame Retardant Chemicals

• Kaiser Permanente has announced that it will stop purchasing

furniture treated with flame retardants

• First health system in the US to do this

• The decision could impact more than 38 hospitals and 600 medical

offices in eight states and the District of Columbia

• New furniture standard specifies that upholstered furniture in new or

remodeled buildings should not contain added fire retardant

chemicals

28

US EPA announces safer alternatives to flame

retardants

• The US EPA announced safer alternatives to the flame retardants

now used in consumer and commercial products

• EPA released a final report on alternatives to the flame retardant

HBCD and an updated draft report on alternatives to the flame

retardant pentaBDE

• Butadiene styrene brominated copolymer is identified as a safer

alternative to HBCD used in polystyrene building insulation and is

currently in commercial production in the US

• Oligomeric phosphonate polyol is identified as a safer alternative to

pentaBDE

29

CEH report card on flame retardants

• The Center for Environmental Health (CEH) released a report card

with information on the use of flame retardant chemicals in national-

brand baby products

• Report card rates companies, including Carters, Naturepedic,

Graco, Baby Bjorn, Fisher Price, Britax and 11 others, on their

progress towards eliminating the use of flame retardant chemicals in

their products

• It also rates companies on their transparency in making information

about flame retardants in their products available to consumers

30

KEMI’s new measures for a toxic-free everyday

environment

• Endocrine disruptors, highly fluorinated substances and allergens

will become the focus of the Swedish Chemicals Agency (KEMI)

over the next five years

• During 2011-2014, KEMI increased the number of inspections and

investigations of substances that children are exposed to in their

everyday life

• The main action will be to develop EU legislation

31

Danish study on rules of chemistry in toys

• A Danish study shows that more than one in three toy

manufacturers, importers or dealers do not know enough about the

rules for chemicals in toys

• The Danish Minister for the Environment, Kirsten Brosbøl, is

launching a new campaign to inform them of the rules and their

obligations in relation to chemicals in toys and other safety aspects

• The Danish EPA will be engaged in extensive spot checks

32

Chile considers revisions to its toy safety rules

• Chile's Ministry of Health (SERNAC) has opened a public

consultation on proposed revisions to its "Rules of Toys," Supreme

Decree No. 114 of 2005

• The proposed revisions would regulate chemical, physical,

mechanical, magnetic properties and labeling of childcare products

and school supplies

• The comment period ran until 4 July 2014

33

Indonesia appoints conformity assessment bodies

for toys

• Indonesia has enacted Regulation No. 18/M-IND/PER/4/2014, to

appoint conformity assessment bodies for certification and testing of

toys to mandatory Indonesian standards

– Regulation No 24/M-IND/PER/4/2013 requires compliance with several

international toy safety standards, including SNI ISO 8124-3:2010,

Safety of toys – Part 3: Migration of toxic elements

– The Regulation also restricts phthalates, azo dyes and formaldehyde in

toys

34

Indonesia delays enforcement of SNI certification

for toys

• Enforcement for toys that have not been

certified to the Indonesian National

Standard (SNI), which should have been

applied by 1 May 2014, has been

postponed until November 2014

• The Indonesian government says the

delay is because there are many small

and medium industries which are not yet

ready

35

List of harmonized standards updated

• The European Commission (EC) has updated its list of harmonized

standards under Directive 2009/48/EC on the safety of toys

• The updated list includes:

– EN 71-7:2014, Safety of toys — Part 7: Finger paints — Requirements

and test methods

– EN 71-13:2014, Safety of toys — Part 13: Olfactory board games,

cosmetic kits and gustative games

36

China considers new toy standards

• The Standardization Administration of China (SAC) has notified the

WTO of proposed toy standards, including:

• National Standard of the P.R.C., Safety of Toys - Part 13: Chemical

Toys (Sets) other than Experimental Sets

– It would specify the requirements and test methods for the substances

and materials used in chemical toys (sets) other than experimental sets

• National Standard of the P.R.C., Safety of Toys - Part 14:

Requirements and Test Methods of Finger Paints

– Chapters 4 and 6 of this standard would be mandatory, the rest would

be recommended

37

Armenian technical regulations on toys

• Armenia has issued Government Decree No. 278-N, 2014,

Approving Technical Regulation on Safety of Toys

• Decree applies to all toys intended for children under 14 years of

age for the purpose of play

• Details safety requirements, labelling and conformity certification

procedures

• Establishes chemical limits, including limits for antimony, arsenic,

barium, cadmium, chromium, lead, mercury and selenium

38

New York bill on chemicals in children’s products

• New York State's Senate is considering a Bill, S4614A, to relate toxic chemicals in children's products

• The Bill would require the Department of Environmental Conservation to post lists of priority chemicals and chemicals of high concern on the department's website within 180 days

• The Bill would require manufacturers of children's products containing an intentionally added priority chemical to report such chemicals within 12 months

• It would also prohibit children's products containing tris (1, 3 dichloro-2-propyl) phosphate, benzene, lead and compounds (inorganic), mercury and mercury compounds including methyl mercury, antimony and antimony compounds, arsenic and arsenic compounds including arsenic trioxide and dimethyl arsenic, cadmium, and cobalt and cobalt compounds

39

Australia considers prohibition on azo dyes

• The Australian government is considering banning potentially

carcinogenic dyes as more retailers identify the chemicals used in

clothing

• In April, Small Business Minister, Bruce Billson, ordered the

Australian Competition and Consumer Commission (ACCC) to

assess whether regulation of the chemicals, known as azo dyes,

should be considered

• ACCC is expected to deliver a report on the use of the potentially

dangerous chemicals in clothing to the Government in July

40

Indonesia amends its restrictions on azo dyes

& formaldehyde

• Indonesia's Ministry of Industry has amended its recent notification

to the WTO regarding the Draft Decree of Minister of Industry on

Mandatory Implementation of Indonesia National Standard for

Textile-Terms of azo dye and formaldehyde levels in the fabric for

baby clothes and children (SNI 7617:2010)

• Ministry specifies a new Decree No. 07/M-IND/PER/2/2014,

mandatory implementation of Indonesia National Standard for Textile

- Terms of Azo Dye and Formaldehyde Levels in the Fabric for Baby

Clothes and Children

• The Decree will take effect in three months

41

China considers a safety standard for infants' &

children's textile products

• The Standardization Administration of China (SAC) has notified the

WTO of a proposed safety standard for infants' and children's textile

products

• The proposed standard would establish safety technical

requirements, test methods and inspection rules for infants' and

children's textile products, including, but not limited to, restrictions

on heavy metals, such as cadmium and lead and restrictions on

phthalates

• The proposed date of entry into force is six months after adoption

42

Denmark EPA study on disperse dyes

• Denmark's Environmental

Protection Agency (EPA) issued a

study on disperse dyes in clothing

in the Danish market

• Per the study, companies do not

focus as much on disperse dyes as

they do on azo dyes

• However, it is estimated that the

project found no indications that

allergenic, disperse dyes constitute

a health-related problem in clothes

on the Danish market

43

RAC and SEAC agree on restriction and

authorization proposals

• European Chemicals Agency's (ECHA) Committee for Risk

Assessment (RAC) and Committee for Socio-economic Analysis

(SEAC) have agreed to a restriction proposal for nonylphenols/

nonylphenol ethoxylates (NPs/ NPEs)

• RAC and SEAC agreed with a Swedish proposal to restrict NPs/

NPEs in textile articles, or textile parts of articles, that can be

washed in water, if the total concentration of these substances is

equal to or higher than 0.01% by weight

• The suggested transitional period is five years after the entry into

force of the restriction

44

Danish EPA guide on product claims

• The Danish Environmental Protection Agency (EPA) has published a

new guide to help businesses that want to endorse their products as

"free of" certain harmful substances

• The guide contains general instructions and specific requirements

for the companies who wish to endorse their products

45

AAFA publishes Restricted Substances List

• In May, the American Apparel & Footwear Association’s (AAFA)

published the fourteenth edition of the AAFA Restricted Substances

List (RSL)

• The RSL covers apparel, footwear, travel goods, home textiles, and

other fashion accessories

• The RSL can be downloaded for free at the AAFA website

46

ZDHC Publishes List of Manufacturing Restricted

Substances

• The Zero Discharge of Hazardous Chemicals (ZDHC) group has

released its Manufacturing Restricted Substances List (MRSL) for

the apparel and footwear industry

• The MRSL establishes concentration limits for substances in

chemical formulations used within manufacturing facilities that

process textile materials and trim parts for apparel and footwear

• The limits are designed to eliminate the possibility of intentional use

of listed substances

• The MRSL contains ~150 substances

47

Danish EPA develops strategies for 'undesirable

substances'

• The Danish Environmental Protection Agency (EPA) has developed

11 strategies for the second group of substances on the list of

undesirable substances (LOUS)

• The substances include, but are not limited to:

1. Phenol

2. Lead and its compounds

3. Copper compounds

4. Certain phthalates

5. Brominated flame retardants

6. Mercury and compounds

7. Tris (2-chloro-1-methylethyl) phosphate (TCPP)

48

Guide to mercury pollution

• The International POPs Elimination Network (IPEN) has announced

a new guide to mercury pollution and the Minamata Convention on

Mercury

– IPEN works to eliminate persistent organic pollutants (POPs) globally

• The booklet provides information about the mercury and its harm to

human health and the environment, and the Minamata Convention

on Mercury

49

Draft Washington State Mercury-Containing Lights

Product Stewardship Program Plan

• Washington State’s Draft Product Stewardship Program Plan for

mercury-containing lights is now available for public review

• The Plan outlines a program intended to reduce improper disposal

practices in the state

• Portions of the Draft Plan are still in process, such as the collection

network, and are noted by PCA Product Stewardship, Inc., in the

plan

50

Webinar on RoHS directive

• C&R data partner, ERA Technology Ltd., UK, recently presented a

webinar, "The Growing Pains of the RoHS Directive"

• This presentation provided an overview of RoHS 2, including the

scope, exemptions, additional substances, a timeline and a market

surveillance update

• If you're interested to see the webinar, email us:

info@compliance@risks.com

51

Expert commentary on RoHS restrictions

• C&R data partner, Chris Robertson, from ERA Technology Ltd., has

provided C2P Expert Commentary on RoHS, "EU: RoHS

Exemptions – How is Industry Planning for the Future?"

• Robertson’s Commentary discusses responses to a survey on

industry's knowledge and planning for RoHS exemptions, as well as

ERA recommendations on a proactive approach to exemption

management

• If you're interested to see the Commentary, email us:

info@complianceandrisks.com

52

Vietnam temporary electronic chemical limits

• Vietnam's Ministry of Industry and Trade has issued Circular

16/VBHN-BCT, officially consolidating its RoHS law

• The law restricts specified substances in electrical and electronic

products, including large appliances, small appliances, IT

equipment, consumer electronics, lighting, and toys

• The law restricts lead, cadmium, mercury, hexavalent chromium,

polybrominated biphenyl and polybrominated diphenyl ethers

• The law specifies that IEC 62321 may be used to assess

compliance with the restrictions

53

EC publishes positions on TTIP topics

• The European Commission (EC) has published negotiating positions

on five important topics of current talks with the US on a future trade

and investment deal, the Transatlantic Trade and Investment

Partnership (TTIP)

• Papers include proposals for enhancing the compatibility of the EU

and US existing rules and regulations, or working more closely

together in setting them in future, in five sectors, including:

– Chemicals

– Cosmetics

– Pharmaceutical products

– Motor vehicles

– Textiles and clothing

54

US bill on dioxin in hygiene products

• The US Federal House of Representatives is considering a bill, H.R.

4746, To amend the Public Health Service Act to establish a

program of research regarding the risks posed by the presence of

dioxin, synthetic fibers, chemical fragrances, and other components

of feminine hygiene products

• The short title of the bill is the Robin Danielson Act of 2014

55

OEHHA considers listing ethylene glycol under

Prop 65

• California’s Office of Environmental Health Hazard Assessment

(OEHHA) announced its intent to list ethylene glycol as a

reproductive toxicant under Proposition 65

• The proposal is based on a 2004 report published by the National

Toxicology Program’s Center for the Evaluation of Risks to Human

Reproduction (NTP-CERHR) that concludes that ethylene glycol

causes reproductive toxicity

• Ethylene glycol is used as an intermediate in the synthesis of

polyester compounds and also a constituent in antifreeze, deicing

fluids, surface coatings, heat transfer fluids and industrial coolants,

hydraulic fluids, surfactants, and emulsifiers

56

OEHHA releases summary for DARTIC's meeting

• California's Office of Environmental Health Hazard Assessment

(OEHHA) has released the meeting synopsis of the Developmental

and Reproductive Toxicant Identification Committee (DARTIC)

meeting, which took place in May

• DARTIC identifies chemicals for addition to the list of chemicals

known to the State to cause reproductive toxicity per Proposition 65

• DARTIC made the following decisions:

– Hexafluoroacetone and phenylphosphine will be retained on the

Proposition 65 list as known to cause reproductive toxicity

– Chlorsulfuron will be removed

57

EC launches CheLIST

• The European Commission's (EC) Institute for Health and

Consumer Protection (IHCP) has launched the Chemical Lists

Information System (CheLIST)

• CheLIST provides a means of identifying whether a chemical has

been used in a research or validation project, as well as whether the

chemical is regulated and listed under a specific regulatory inventory

• CheLIST provides information on chemical identifiers (e.g., name,

CAS number) and chemical structure

– The database can be searched according to these types of information

58

DUCC issues guidance on chemical exposure

assessment

• The European Downstream Users of Chemicals Co-ordination

Group (DUCC) has issued guidance on Specific Consumer

Exposure Determinants (SCEDs) for chemical exposure assessment

under the REACH Regulation

• Document provides guidance for the use of SCEDs for consumer

exposure assessment, be it by registrants in their chemical safety

assessment or by downstream users or for other REACH processes

59

Second edition of Guidance on Grouping of

Chemicals

• The Organisation for Economic Co-

operation and Development (OECD) has

issued the second edition of its Guidance

on Grouping of Chemicals

• The Guidance is intended to support

assessments of the hazards of chemical

substances, while gaining efficiencies and

improving animal welfare

• The approach considers closely related

chemicals as a group, or category, rather

than as individual chemicals

60

Canada notice on hydrofluorocarbons

• Canada's Minister of the Environment has issued a notice with

respect to hydrofluorocarbons (HFCs)

• The Notice applies to hydrofluorocarbons that have the molecular

formula CnHxF(2n+2-x) in which 0<n<6 as listed

• The Notice applies to notice any person who, during any calendar

year from 2008-2012, manufactured, importerd or exported a total

quantity greater than 100 kg of one of the listed substances, at a

concentration equal to or above 1 percent by weight (w/w%)

• Information must be provided by 19 August 2014

61

ECHA documents on biocidal products regulation

• The European Chemicals Agency (ECHA) has issued three

"Transitional Guidance" documents on biocidal products

• The Guidance is "Transitional,” as it will soon be replaced by new

guidance, under the new Biocidal Products Regulation

• The Guidance covers:

– Efficacy assessment for Product Type 21 antifouling products

– Efficacy assessment of preservatives

– Mixture toxicity assessment for biocidal products for the environment

62

EC reports on labeling of nanomaterials

• The European Commission (EC), Joint Research Centre (JRC),

Institute for Health and Consumer Protection have published a

report on information needs for nanomaterials (NMs) in consumer

products

• The report discusses two means of providing transparency and

traceability of NMs on the market

– Labeling of products containing NMs

– Collecting information in a product register or inventory

• The report provides an overview of the scientific challenges to verify

the presence (identity and concentration) of NMs in products

63

European Commission on safety of

silvernanpoarticles

• The European Commission (EC) has issued a fact sheet on safety

of silver nanoparticles in medical and consumer products

• Per the fact sheet, the toxicity of silver, including nanoparticles of

silver, to humans is generally low

• Skin contact with textiles containing silver is one of the main ways

people are exposed to silver nanoparticles

• Generally, consumer products release only small amounts of silver,

not resulting in significant health effects

64

US FDA guidance on nanotechnology products

• The US FDA has issued three final guidance and one draft guidance

to provide greater regulatory clarity for industry on the use of

nanotechnology in FDA-regulated products

• One final guidance addresses the agency’s overall approach for all

products that it regulates, while the other two and the new draft

guidance provide specific guidance for the areas of foods, cosmetics

and food for animals, respectively

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Expert commentary on FDA Guidance

• C&R data partner, Bergeson & Campbell, P.C., has drafted C2P

Expert Commentary regarding FDA's recent Final Nanotechnology

Guidances and Draft Guidance for Comment.

• Per the firm, each of the final and draft guidances encourages

industry to consult with FDA, either early in the product development

process, when considering a significant change to the manufacturing

process for a food substance already in the market, or early in the

development of their nanomaterial animal food ingredient and before

submitting an FAP

• If you're interested to see the Commentary, email us:

info@complianceandrisks.com

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Danish order on nano products enters into force

• Denmark’s order concerning a nano products register entered into

force on 18 June 2014

• The order imposes annual reporting requirements on manufacturers

and importers of mixtures and products containing nanomaterials

• Certain products are excluded from the reporting obligation,

including food and food contact materials; feed; drugs; medical

equipment; cosmetic products; pesticides; and waste

• The first reports, for the period beginning 20 June 2014 and ending

20 June 2015, are due 30 August 2015

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Four SVHCs added to Candidate List

• Four more substances have been added to the Candidate List of

Substances of Very High Concern for Authorisation (SVHCs) under

REACH

• These newly added substances are:

– Cadmium chloride

– 1,2-Benzenedicarboxylic Acid, Dihexyl Ester, Branched and Linear

– Sodium Peroxometaborate

– Sodium Perborate, also called Perboric Acid, Sodium Salt

• The candidate list now contains 155 substances

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Iowa considers a prohibition on triclosan

• The state of Iowa is considering a Bill, Senate File 2346, to prohibit

the manufacture, sale or distribution of soap, hand sanitizer or

toothpaste containing triclosan

• The Bill would also require manufacturers to use "the least toxic

alternative" when replacing triclosan in these products

• The Bill would take effect 1 January 2015

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Illinois enacts microbead prohibition

• The state of Illinois has enacted Public Act 098-0638, An act

concerning safety, to establish a new prohibition on microbeads

• The Act applies to "synthetic plastic microbeads," defined to mean

any intentionally added non-biodegradable solid plastic particle

measured less than 5 mm in size and is used to exfoliate or cleanse

in a rinse-off product

• The Act prohibits personal care products, except for OTC drugs, that

contain synthetic plastic microbeads

• The Act takes effect 31 December 2017

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My co-presenter, Rex

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Compliance & Risks: Your partner in global

compliance

• We help you succeed in an ever-evolving regulatory environment

• Our webinars, like the CQ, help clients to proactively respond to the latest proposed, enacted and amended regulations and standards globally

• Contact us to:

– register for CQ;

– sign up for a demonstration and 30-day trial of our online regulatory platform, C2P; or

– schedule a “needs assessment” with one of our experts!

• E: info@complianceandrisks.com

• W: www.complianceandrisks.com

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