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Compliance
Update
Q1 2012
Presented by Stacey Bowers, MILS
4 April 2012




                                   Compliance Update: Q1 2012   |   2
Chemicals of high concern
Washington State's Department
of Ecology adopted the
Children's Safe Product Act
Reporting Rule

Ecology and the Department of Health developed a list of
Reporting List of Chemicals of High Concern to Children

Beginning in August 2012, manufacturers of children's
products must report to Ecology if their products contain
these chemicals




                                           Compliance Update: Q1 2012   |   3
AAFA RSL
AAFA released the 10th edition of its Restricted
Substances List (RSL) in March 2012

The new edition addressed:

•practical quantification limits (PQLs) per Washington
Children's Safe Product Act
•cadmium restrictions per Switzerland’s ORRChim
•new lead limits per the US CPSIA




                                          Compliance Update: Q1 2012   |   4
Chemicals in children’s products
Thus far, in 2012, 7 states have proposed bills to restrict
chemicals in children's products:

• Connecticut
• Illinois
• Maryland
• Minnesota
• New York State
• Oregon
• Washington State




                                            Compliance Update: Q1 2012   |   5
Chemicals of concern
In October 2011, California's DTSC issued a new draft of
its Safer Consumer Products Regulations

The draft establishes a list of chemicals of concern,
among other requirements

DTSC hosted a public workshop on the draft Regulations
in December 2011

The draft Regulations have still not been enacted




                                           Compliance Update: Q1 2012   |   6
Chemicals of concern
The Canadian Parliament is considering Bill C-408

The bill would require a warning label for any product that
contains or produces a toxic substance when used

The bill defines toxic substances as per:

•substances identified in the IARC Monographs on the Evaluation of Carcinogenic
Risks to Humans;
•substances identified as carcinogenic, mutagenic, or toxic to development or
reproduction, or classified as endocrine disrupting by:
     • the ECHA,
     • any EU Directive or Regulation,
     • California’s Governor or OEHHA,
     • the US NTP list of carcinogens,
     • the US EPA, or
     • Health Canada or Environment Canada

                                                         Compliance Update: Q1 2012   |   7
BPA in food contact
BPA is restricted in several cities, counties and states:
•Chicago, Illinois           •   California
                             •   Connecticut
•Albany County, New York     •   Delaware
•Multnomah County, Oregon    •   Maine
•Rockland County, New York   •   Maryland
•Schenectady County,         •   Massachusetts
•New York                    •   Minnesota
•Suffolk County, New York    •   New York
                             •   Vermont
                             •   Washington, DC
                             •   Washington State
                             •   Wisconsin




                                             Compliance Update: Q1 2012   |   8
BPA in food contact
In April 2012, the US FDA rejected an NRDC petition to
ban BPA in food contact articles
     •   FDA stated, “…[T]his is not a final safety determination on
         BPA”

In 2012, several states have proposed bills to ban BPA:
     •   Arizona                 •   New Hampshire
     •   Colorado                •   New York
     •   Hawaii                  •   South Dakota
     •   Kentucky                •   West Virginia
     •   Massachusetts

The Belgian Senate and France’s ANSES are also
considering bans on BPA in food contact materials and
articles for children under the age of 3

                                                  Compliance Update: Q1 2012   |   9
Heavy metals in jewelry
Rhode Island has proposed S 2482, Comprehensive
Children's Jewelry Safety Act
•The Act would require children's jewelry to comply with ASTM F2923


Michigan Network for Children's Environmental Health and
the Ecology Center tested adult and children’s jewelry:
•59% of the products had high levels of at least one toxic chemical;
•10% contained greater than 100 ppm cadmium;
•93% contained greater than 100 ppm chromium;
•27% contained greater than 300 ppm lead


The European Commission proposed a restriction on lead
in children’s jewelry
•The proposal would limit lead to 0.05% by weight, unless the rate of lead
release is less than 0.05 μg/cm²/hr


                                                         Compliance Update: Q1 2012   |   10
Heavy metals in toys
The EC established lower migration limits for cadmium in
toys per Directive 2012/7/EU
•The new reduced limits come into force on 20 July 2013

The EC is considering lower migration limits for lead in
toys
•The public comment period ended 7 March 2012

The EC permitted Germany to maintain its lower limits for
lead, barium, and nitrosamines and nitrosatable
substances in toys, per Decision 2012/160/EU
•The lead and barium limits are approved until the EU approves new
lead limits or 21 July 2013, whichever is first



                                                Compliance Update: Q1 2012   |   11
8 new banned substances per REACH
In February, the EU published Regulation (EU)
No 125/2012 to include 8 additional substances ECHA
Candidate List to Annex XIV of REACH

These 8 substances will be banned from 2015, unless an
authorization is granted to individual companies for their
use

These requirements apply regardless of the tonnage
at which the substance is placed on the market or used

With the addition of these 8 substances, Annex XIV now
contains 14 substances

                                          Compliance Update: Q1 2012   |   12
Proposed SVHCs per REACH
In Q4 2011 and Q1 2012, ECHA has recommended a
number of SVHCs be added to Annex XIV of REACH,
including:

• DIBP, DBP, BBP, and DEHP;
• DMFu;
• lead and its compounds;
• mercury; and
• phenylmercury compounds

If included in Annex XIV, these substances will be banned
from use within the next 3-5 years, unless an
authorization is granted to individual companies for their
use

                                          Compliance Update: Q1 2012   |   13
Phthalates in skin contact articles
In January, Denmark proposed a restriction of 4
phthalates – DEHP, BBP, DBP and DIBP – in indoor
articles and articles that come in contact with skin or
mucous membranes per REACH:

• Proposed limits are 1000 mg/kg of one or more of these 4
phthalates
• The comment period ended 16 March 2012




                                                 Compliance Update: Q1 2012   |   14
PoHS
In December 2011, the Norwegian
Pollution Control Authority notified
the WTO of a proposed amendment
to its Product Control Act

The amendment – the Prohibition on Certain Hazardous
Substances in Consumer Products – would prohibit lead,
PCP, PFOA, and MCCP in nearly all consumer products

If enacted, the ban would enter into force on 1 July 2012




                                          Compliance Update: Q1 2012   |   15
ORRChim
Switzerland has proposed an amendment to its Chemical
Risk Reduction Ordinance, commonly called ORRChim

The amendment would align the Ordinance with REACH

The proposal would establish Swiss restrictions on:
   •   brominated flame retardants,
   •   cadmium,
   •   cyclohexane and
   •   organotin compounds




                                         Compliance Update: Q1 2012   |   16
Phthalates & organotin compounds
Korea’s MoE proposed to restrict DNOP, DINP, NP,
chloroethylene and organotin compounds in children’s
Products

The proposal would limit these chemicals in children’s
products, including bottles and toys, as well as in
children’s environments, such as day care centers and
playgrounds




                                         Compliance Update: Q1 2012   |   17
ASTM F963 is updated
ASTM F963:2011 was published in
December 2011

The revision includes:
•clarification on plastic packaging film;
•revisions to heavy metals limits, in harmony with
16 CFR 1303 and EN 71-3;
•new compositing testing for total digestion; and
•guidance on alternative tests, such as XRF testing

In February, the US CPSC voted to accept the revisions
to
ASTM F963:2011

The 2011 edition will become mandatory on 12 June 2012
                                                  Compliance Update: Q1 2012   |   18
Guidance on the NTSD
In January, the EC published 3 guidance documents on
the New Toy Safety Directive (2009/48/EC)

The revised Toy Safety Directive
Explanatory Guidance Document
provides clarification regarding:
•the NTSD and REACH;
•better wording for warnings;
•the wording of Doc;
•visibility requirements

The other 2 documents relate to:
•sports equipment versus toys
•writing instruments and stationary items


                                            Compliance Update: Q1 2012   |   19
Proposed toy requirements in Switzerland
Switzerland’s BAFU proposed revisions of its Ordinance
on Toy Safety (RS 817.044.1) and the Ordinance on
Foodstuffs and Utility Articles (RS 817.02)

The revisions would implement the EU's NTSD, including:

•obligations of manufacturers, importers and distributors;
•safety requirements for toys;
•warning requirements; and
•traceability




                                                   Compliance Update: Q1 2012   |   20
Unsafe products in the Caribbean
In March, CARICOM launched an online system for
consumers to alert authorities on unsafe products

The service – the CARICOM Rapid Exchange System for
Dangerous non-food Consumer Goods, or CARREX –
covers non-food consumer products, including electrical
products and toys

National Contact Points were created in Antigua and
Barbuda, Barbados, Belize, Dominica, Grenada, Guyana,
Haiti, Jamaica, Montserrat, St. Kitts and Nevis, St. Lucia,
St. Vincent and the Grenadines, Suriname, and Trinidad
and Tobago

                                           Compliance Update: Q1 2012   |   21
Global toy symbols
Spain's AIJU proposed a free, universal iconography for
the global toy industry

The system is comprised of a universal set of 15-20 icons
for issues such as:

•age-grading,
•technical aspects (e.g., sound, use of
batteries, etc.),
•educational features, and
•a toy’s fit for children with special needs

The system is designed to improve consumer
understanding and to simplify the labeling process for
manufacturers
                                               Compliance Update: Q1 2012   |   22
Amended toy requirements in Korea
Korea's KATS revised its criteria for toys subject to
self-regulatory confirmation per the Quality Management
and Safety Control of Industrial Products Act

The amendment:
•reflects new versions of ISO 8124-1 through -4;
•adds new requirements for chemical experiment sets, chemical toys
and finger paints; and
•adds requirements for charge indicator LEDs for electric toys

These new requirements take effect 1 January 2013




                                                Compliance Update: Q1 2012   |   23
New apparel requirements in Egypt
Egypt's MFTI issued a new
Ministerial Decree, 626/2011

Per the Decree, apparel must comply with restrictions on
chemicals such as azo dyes, formaldehyde and flame
retardants

Imported apparel must be labeled with fiber composition,
care instructions, country of origin, manufacturer
identification and product identification

These requirements took effect 1 April 2012



                                         Compliance Update: Q1 2012   |   24
Proposed apparel requirements in Indonesia
Indonesia’s Minister of Industry and Trade proposed a
decree to on baby and children’s clothing

The decree would require such
clothing to comply with SNI 7617,
which establishes:
•restrictions on azo dyes,
•restrictions on formaldehyde,
•labeling requirements, and
•testing requirements

Baby and children’s clothing would be required to bear
the SNI Mark


                                          Compliance Update: Q1 2012   |   25
Thank You!




             Compliance Update: Q1 2012   |   26

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Compliance Update Q1 2012

  • 1. 1
  • 2. Compliance Update Q1 2012 Presented by Stacey Bowers, MILS 4 April 2012 Compliance Update: Q1 2012 | 2
  • 3. Chemicals of high concern Washington State's Department of Ecology adopted the Children's Safe Product Act Reporting Rule Ecology and the Department of Health developed a list of Reporting List of Chemicals of High Concern to Children Beginning in August 2012, manufacturers of children's products must report to Ecology if their products contain these chemicals Compliance Update: Q1 2012 | 3
  • 4. AAFA RSL AAFA released the 10th edition of its Restricted Substances List (RSL) in March 2012 The new edition addressed: •practical quantification limits (PQLs) per Washington Children's Safe Product Act •cadmium restrictions per Switzerland’s ORRChim •new lead limits per the US CPSIA Compliance Update: Q1 2012 | 4
  • 5. Chemicals in children’s products Thus far, in 2012, 7 states have proposed bills to restrict chemicals in children's products: • Connecticut • Illinois • Maryland • Minnesota • New York State • Oregon • Washington State Compliance Update: Q1 2012 | 5
  • 6. Chemicals of concern In October 2011, California's DTSC issued a new draft of its Safer Consumer Products Regulations The draft establishes a list of chemicals of concern, among other requirements DTSC hosted a public workshop on the draft Regulations in December 2011 The draft Regulations have still not been enacted Compliance Update: Q1 2012 | 6
  • 7. Chemicals of concern The Canadian Parliament is considering Bill C-408 The bill would require a warning label for any product that contains or produces a toxic substance when used The bill defines toxic substances as per: •substances identified in the IARC Monographs on the Evaluation of Carcinogenic Risks to Humans; •substances identified as carcinogenic, mutagenic, or toxic to development or reproduction, or classified as endocrine disrupting by: • the ECHA, • any EU Directive or Regulation, • California’s Governor or OEHHA, • the US NTP list of carcinogens, • the US EPA, or • Health Canada or Environment Canada Compliance Update: Q1 2012 | 7
  • 8. BPA in food contact BPA is restricted in several cities, counties and states: •Chicago, Illinois • California • Connecticut •Albany County, New York • Delaware •Multnomah County, Oregon • Maine •Rockland County, New York • Maryland •Schenectady County, • Massachusetts •New York • Minnesota •Suffolk County, New York • New York • Vermont • Washington, DC • Washington State • Wisconsin Compliance Update: Q1 2012 | 8
  • 9. BPA in food contact In April 2012, the US FDA rejected an NRDC petition to ban BPA in food contact articles • FDA stated, “…[T]his is not a final safety determination on BPA” In 2012, several states have proposed bills to ban BPA: • Arizona • New Hampshire • Colorado • New York • Hawaii • South Dakota • Kentucky • West Virginia • Massachusetts The Belgian Senate and France’s ANSES are also considering bans on BPA in food contact materials and articles for children under the age of 3 Compliance Update: Q1 2012 | 9
  • 10. Heavy metals in jewelry Rhode Island has proposed S 2482, Comprehensive Children's Jewelry Safety Act •The Act would require children's jewelry to comply with ASTM F2923 Michigan Network for Children's Environmental Health and the Ecology Center tested adult and children’s jewelry: •59% of the products had high levels of at least one toxic chemical; •10% contained greater than 100 ppm cadmium; •93% contained greater than 100 ppm chromium; •27% contained greater than 300 ppm lead The European Commission proposed a restriction on lead in children’s jewelry •The proposal would limit lead to 0.05% by weight, unless the rate of lead release is less than 0.05 μg/cm²/hr Compliance Update: Q1 2012 | 10
  • 11. Heavy metals in toys The EC established lower migration limits for cadmium in toys per Directive 2012/7/EU •The new reduced limits come into force on 20 July 2013 The EC is considering lower migration limits for lead in toys •The public comment period ended 7 March 2012 The EC permitted Germany to maintain its lower limits for lead, barium, and nitrosamines and nitrosatable substances in toys, per Decision 2012/160/EU •The lead and barium limits are approved until the EU approves new lead limits or 21 July 2013, whichever is first Compliance Update: Q1 2012 | 11
  • 12. 8 new banned substances per REACH In February, the EU published Regulation (EU) No 125/2012 to include 8 additional substances ECHA Candidate List to Annex XIV of REACH These 8 substances will be banned from 2015, unless an authorization is granted to individual companies for their use These requirements apply regardless of the tonnage at which the substance is placed on the market or used With the addition of these 8 substances, Annex XIV now contains 14 substances Compliance Update: Q1 2012 | 12
  • 13. Proposed SVHCs per REACH In Q4 2011 and Q1 2012, ECHA has recommended a number of SVHCs be added to Annex XIV of REACH, including: • DIBP, DBP, BBP, and DEHP; • DMFu; • lead and its compounds; • mercury; and • phenylmercury compounds If included in Annex XIV, these substances will be banned from use within the next 3-5 years, unless an authorization is granted to individual companies for their use Compliance Update: Q1 2012 | 13
  • 14. Phthalates in skin contact articles In January, Denmark proposed a restriction of 4 phthalates – DEHP, BBP, DBP and DIBP – in indoor articles and articles that come in contact with skin or mucous membranes per REACH: • Proposed limits are 1000 mg/kg of one or more of these 4 phthalates • The comment period ended 16 March 2012 Compliance Update: Q1 2012 | 14
  • 15. PoHS In December 2011, the Norwegian Pollution Control Authority notified the WTO of a proposed amendment to its Product Control Act The amendment – the Prohibition on Certain Hazardous Substances in Consumer Products – would prohibit lead, PCP, PFOA, and MCCP in nearly all consumer products If enacted, the ban would enter into force on 1 July 2012 Compliance Update: Q1 2012 | 15
  • 16. ORRChim Switzerland has proposed an amendment to its Chemical Risk Reduction Ordinance, commonly called ORRChim The amendment would align the Ordinance with REACH The proposal would establish Swiss restrictions on: • brominated flame retardants, • cadmium, • cyclohexane and • organotin compounds Compliance Update: Q1 2012 | 16
  • 17. Phthalates & organotin compounds Korea’s MoE proposed to restrict DNOP, DINP, NP, chloroethylene and organotin compounds in children’s Products The proposal would limit these chemicals in children’s products, including bottles and toys, as well as in children’s environments, such as day care centers and playgrounds Compliance Update: Q1 2012 | 17
  • 18. ASTM F963 is updated ASTM F963:2011 was published in December 2011 The revision includes: •clarification on plastic packaging film; •revisions to heavy metals limits, in harmony with 16 CFR 1303 and EN 71-3; •new compositing testing for total digestion; and •guidance on alternative tests, such as XRF testing In February, the US CPSC voted to accept the revisions to ASTM F963:2011 The 2011 edition will become mandatory on 12 June 2012 Compliance Update: Q1 2012 | 18
  • 19. Guidance on the NTSD In January, the EC published 3 guidance documents on the New Toy Safety Directive (2009/48/EC) The revised Toy Safety Directive Explanatory Guidance Document provides clarification regarding: •the NTSD and REACH; •better wording for warnings; •the wording of Doc; •visibility requirements The other 2 documents relate to: •sports equipment versus toys •writing instruments and stationary items Compliance Update: Q1 2012 | 19
  • 20. Proposed toy requirements in Switzerland Switzerland’s BAFU proposed revisions of its Ordinance on Toy Safety (RS 817.044.1) and the Ordinance on Foodstuffs and Utility Articles (RS 817.02) The revisions would implement the EU's NTSD, including: •obligations of manufacturers, importers and distributors; •safety requirements for toys; •warning requirements; and •traceability Compliance Update: Q1 2012 | 20
  • 21. Unsafe products in the Caribbean In March, CARICOM launched an online system for consumers to alert authorities on unsafe products The service – the CARICOM Rapid Exchange System for Dangerous non-food Consumer Goods, or CARREX – covers non-food consumer products, including electrical products and toys National Contact Points were created in Antigua and Barbuda, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Suriname, and Trinidad and Tobago Compliance Update: Q1 2012 | 21
  • 22. Global toy symbols Spain's AIJU proposed a free, universal iconography for the global toy industry The system is comprised of a universal set of 15-20 icons for issues such as: •age-grading, •technical aspects (e.g., sound, use of batteries, etc.), •educational features, and •a toy’s fit for children with special needs The system is designed to improve consumer understanding and to simplify the labeling process for manufacturers Compliance Update: Q1 2012 | 22
  • 23. Amended toy requirements in Korea Korea's KATS revised its criteria for toys subject to self-regulatory confirmation per the Quality Management and Safety Control of Industrial Products Act The amendment: •reflects new versions of ISO 8124-1 through -4; •adds new requirements for chemical experiment sets, chemical toys and finger paints; and •adds requirements for charge indicator LEDs for electric toys These new requirements take effect 1 January 2013 Compliance Update: Q1 2012 | 23
  • 24. New apparel requirements in Egypt Egypt's MFTI issued a new Ministerial Decree, 626/2011 Per the Decree, apparel must comply with restrictions on chemicals such as azo dyes, formaldehyde and flame retardants Imported apparel must be labeled with fiber composition, care instructions, country of origin, manufacturer identification and product identification These requirements took effect 1 April 2012 Compliance Update: Q1 2012 | 24
  • 25. Proposed apparel requirements in Indonesia Indonesia’s Minister of Industry and Trade proposed a decree to on baby and children’s clothing The decree would require such clothing to comply with SNI 7617, which establishes: •restrictions on azo dyes, •restrictions on formaldehyde, •labeling requirements, and •testing requirements Baby and children’s clothing would be required to bear the SNI Mark Compliance Update: Q1 2012 | 25
  • 26. Thank You! Compliance Update: Q1 2012 | 26