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Europe Nickel Release for Children's Jewelry

The children's Jewelry is one of high demand for retailers such as clothes chain store, because the children fashion trend.

Nickel release is used in metal alloy for corrosion resistance. Dermatitis can be occurred if there is long skin contact with nickel.

From REACH Annex XVII in Europe:

Prolonged contact with the skin is defined as contact with the skin to articles containing nickel of potentially more than

• 10 minutes on three or more occasions within two weeks, or
• 30 minutes on one or more occasions within two weeks.

The skin contact time of 10 minutes applies when there are three or more occasions of skin contacts within a two-week time period. The skin contact time of 30 minutes applies when there is at least one occasion within a two-week time period.

• Non-body piercing
  ≤ 0.5 μg/cm²/week limit
  

  Pass if	Fail if
  < 0.88 μg/cm²/week	≥ 0.88 μg/cm²/week

• For body piercing
  < 0.2 μg/cm²/week limit:
  

  Pass if	Fail if
  < 0.35 μg/cm²/week	≥ 0.35 μg/cm²/week

PAHs in Europe

On 6 December 2013, Commission Regulation (EU) No 1272/2013 was published on the Official Journal which extended the restriction of polycyclic aromatic hydrocarbon (PAHs) to rubber or plastic components in articles that come into direct and prolonged or short-term repetitive contact with human skin or the oral cavity, under normal or reasonably foreseeable conditions of use. This regulation has also amended the REACH regulation by adding the PAHs requirements under entry 50 of Annex XVII of REACH. The new requirements shall be effective from 27 December 2015. This requirement is summarized as below:

PAHs, CAS No.	Restricted in rubber or plastic components in articles with prolonged skin contact	Requirement (each PAH)
. Benzo[a]pyrene (BaP), 50-32-8 . Benzo[e]pyrene (BeP), 192-97-2 . Benzo[a]anthracene (BaA), 56-55-3 . Chrysen (CHR), 218-01-9 . Benzo[b]flouranthene (BbFA), 205-99-2 . Benzo[j]flouranthene (BjFA), 205-82-3 . Benzo[k]flouranthene (BkFA), 207-08-9 . Dibenzo[a,h]anthrcene (DBAhA), 53-70-3	Ø    Toys including activity toys and childcare articles	£ 0.5 mg/ kg
	Ø    Sport equipment such as bicycles, golf clubs, racquets Ø    House-hold utensils, trolleys, walking frames Ø    Tools for domestic use Ø    Clothing, footwear, gloves and sportswear Ø    Watch-straps, wrist-bands, masks, head-bands	£ 1 mg/ kg

These PAHs are present as impurities in some of the raw materials used in the production of plastic and rubber parts of a wide range of consumer products, in particular in extender oils and in carbon black. They are not added intentionally to the articles and do not perform any specific function. These PAHs are banned for sale as substances on their own or in mixtures to the general public by entry 28 of Annex XVII to REACH. Entry 50 of Annex XVII to REACH already restricted the presence of PAHs in extender oils used for the production of tyres.

Effective Date:	27 December 2015
Scope:	Rubber or plastic with prolonged skin contact
Hazard:	PAHs
Limit:	Refer to above details
Risk:	https://en.wikipedia.org/wiki/Polycyclic_aromatic_hydrocarbon

Total Lead Content in Europe REACH

In additional to Jewelry and its' component, the articles or accessible parts which may be placed in the
mouth by children should not have lead content more than 0.05%

Safety / Risk Assessment

 The safety/ risk assessment is a hot topic at the beginning of 2009/48/EC,  that mentioned in Article 18 “ Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability and radioactivity hazard that the toy may present, as well as an assessment of the potential exposure to such hazards.”

EN71 is harmonized standard for assessment of physical, mechanical, flammability and some chemical hazards.

The assessment can be conducted by manufacturer or labs. There is no accreditation requirement and any format for assessment report in the 2009/48/EC. Assessment records cover all hazards area is okay, it may not assess according to EN71 standards.

US CPSIA 10 Phthalates Proposed

On 30 December 2014, the proposed rule 16 CFR Part 1307 - “Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates” was published on Federal Register Notice by CPSC (Consumer Product Safety Commission). 

The amendments are summarized as below and will be effective on 180 days after the final rule promulgated on Federal Register.

     

Phthalates	Proposed Scope	Previous Scope
DEHP	Permanent ban for children's toy or child care article *1	Permanent ban for children's toy or child care article
DBP
BBP
DIBP		Not applicable
DPENP
DHEXP
DCHP
DINP		Interim ban for mouthable toy or child care article
DNOP	Interim ban NOT be continued
DIDP

^*1 The limit for each phthalate is <0.1%. DIBP, DPENP, DHEXP, DCHP are newly specificed.

Europe EN71 Part 3 proposed update on lead limit

The European Commission is proposing to amend the lead limit in Annex II of Directive 2009/48/EC: 

	In dry brittle, powder like or pliable toy material (mg/kg)	In liquid or sticky toy material (mg/kg)	In scraped –off toy material (mg/kg)
Current Lead limits	13.5	3.4	160
Proposed Lead limits	2.0	0.5	23

Formamide Regulation in France and Taiwan

For Europe:

The formamide is proposing to be added in 2009/48/EC with limit for toys (playmat is included) as below 

Refer: http://ec.europa.eu/enterprise/tbt/tbt_repository/EU231_EN_1_1.pdf

While above propose is not effective yet, the Europe regulation for consumer product should be as below:

The marketing of puzzle mats containing formamide was restricted in some member States. Can formamide be used in toys?

Formamide is a CMR classified as reprotoxic cat 2 (or 1 B according to 1272/2008).

According to the current Toy safety directive 88/378/EEC, toys shall not contain dangerous substances in amounts which may harm the safety and health of children.
It is the responsibility of the manufacturer to demonstrate that toys they place on the EU market comply with this requirement. National market surveillance authorities have the obligation to verify and take measures the case may be.

The new Toy Safety Directive 2009/48 introduces, as from July 2013, a general ban on CMRs substances. As an exception, they can be used when they are contained in concentrations equal or below the concentrations mentioned in Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (0.5% for formamide).

Refer: http://ec.europa.eu/DocsRoom/documents/5572/attachments/1/translations/en/renditions/native

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For France, the national regulation for puzzle playmat is as

Limit: <200 mg/kg

Refer: http://www.legifrance.gouv.fr/affichTexte.do;jsessionid=?cidTexte=JORFTEXT000026258509&dateTexte=&oldAction=rechJO&categorieLien=id

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For Taiwan, the national regulation for Toys and playmat are:

Limit: <2mg/kg (which is same as the withdrawed limit of France on 1 August 2012)

Refer: http://www.cnsonline.com.tw/?node=result&generalno=15493&locale=zh_TW

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The taiwan requirement was commented by European commission as below:

https://members.wto.org/crnattachments/2014/tbt/CHT/14_2983_00_e.pdf

http://ec.europa.eu/enterprise/tbt/tbt_repository/TPKM165_EN_1.pdf

ISO 8124 Part 6, Phthalate plasticizers in toys

ISO 8124-6:2014 specifies a method for the determination of di-n-butyl phthalate (DBP), benzyl butyl phthalate (BBP), bis-(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DNOP), di-iso-nonyl phthalate (DINP), and di-iso-decyl phthalate (DIDP) (see Annex A) in toys and children's products.

ISO 8124-6:2014 is applicable to toys and children's products which are made of plastics, textiles, and coatings, etc.

CPSC Releases CHAP on Phthalates and Alternatives

The U.S. Consumer Product Safety Commission (CPSC) announced the release of a report detailing the potential effects on children’s health of phthalates and phthalate alternatives as used in toys and child care articles.

The CPSC-appointed Chronic Hazard Advisory Panel (CHAP) recommended:

1) lifting the interim bans on DnOP and DIDP and permanently banning DINP.
2) permanently banning four additional phthalates (DIBP, DPenP, DHexP and DCHP) from use in children’s toys and child care articles at levels greater than 0.1%.
3.) imposing an interim ban on DIOP from use in children’s toys and child care articles at levels greater than 0.1%.

The CHAP report concluded that food, beverages, and drugs via direct ingestion, and not children’s toys and their personal care products, constituted the highest phthalate exposures to all subpopulations, with the highest exposure being dependent upon the phthalate and the products that contain it. The report also found that DINP had the maximum potential for exposure for infants, toddlers, and older children, primarily from food but also from mouthing teethers and toys, and from dermal contact with child care articles and home furnishings.

The CPSC has 180 days from the release of the CHAP Report to evaluate the findings and promulgate a rule based on the report.

https://www.cpsc.gov/en/Regulations-Laws--Standards/Statutes/The-Consumer-Product-Safety-Improvement-Act/Phthalates/Chronic-Hazard-Advisory-Panel-CHAP-on-Phthalates/

EN71 Part 12 Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances

Regulated Chemical:
Nitrosamines and Nitrosatable Substances
Counties:
Europe
Effective Date:
20 July 2013
Scope:
Elastomers in toys and parts of toys intended for use by children under 36 months (e.g. teethers)

Elastomers in toys and parts of toys intended to be placed in the mouth (e.g. balloons)

Finger paints

Limit:

 Tab1. The limits of  N-nitrosamines and N-nitrosatable substances(mg/kg)

Substances	Scope
	elastomeric toys and parts of toys intended for use by children under 36 months	elastomeric toys and parts of toys intended to be placed in the mouth(e.g. balloons and teethers)	finger paints intended for use by children under 36 months
N-nitrosamines	0.05		0.02
N-nitrosatable substances	1.0		1.0

Canada and US Pen Ink Requirement

Accordance to CCPSA/CPSIA

“surface coating material” means a paint or other similar material that dries to a solid film when a layer of it is applied to a surface. It does not include a material that becomes a part of the substrate. 

Pen ink should not under the scope. They should perform TRA for Canada requirement. 

ST2012 Japan Toys Safety Standards Update

Port Surveillance News: CPSC Stops More Than 12.5 Million Units of Violative Products from Reaching Homes in Fiscal Year 2013

3^rd & 4^th Quarters, FY 2013

NOTE: Data are from samples collected from April 1, 2013 to September 30, 2013. The quantities below are approximate. Minor changes may occur due to updated data.

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 Total number of screenings – 14,111

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Total number of products stopped –           616

Total number of units stopped –                  8,214,887

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Children’s Products

Total number of products stopped –           548 (89%)

Total number of units stopped –                  2,091,737 (25%)

Products Stopped by Primary Violation/Defect

Lead – 225 (paint 14; content 211) (41%)

Phthalates – 114 (20%)

Tracking labels – 62 (11%)

Art materials – 49 (8%)

Small parts – 39 (7%)

Certification – 21 (3%)

Durable nursery products – 21 (3%)

Misbranded toys – 15 (2%)

Misbranded balloons – 8 (1%)

Battery-operated toys – 5 (1%)

The remaining 3 percent included drawstrings, pacifiers, and rattles.           

Six Phthalate quantity

Europe Phthalate should be quoted 3 in 1 for all plastic with coating together.

US phthalate should be quoted 3 in 1 while may only for high risk plastic.

HK phthalate follow Europe.

Toy magnetic hazards

The small magnets can easily detach from the product, posing an ingestion hazard to children. If a child swallows more than one magnet, the magnets can attract while travelling through the intestines, and cause blockages or holes in the intestinal walls. 

Although firms that sell magnet sets state that they intend them as desk toys
for adults, these sets are found in offices and homes and in locations within the
home beyond desk tops, such as on refrigerators. Magnet sets have some
appeal for virtually all age groups. They tend to capture attention because they
are shiny and reflect light. They are smooth, which gives them tactile appeal, and they make soft snapping sounds as they are manipulated. They have the properties of a novelty, which arouses curiosity; incongruity, which tends to surprise and amuse; and complexity, which tends to challenge and maintain interest. Their strong magnetic properties cause them to move in unexpected ways, with pieces snapping together suddenly, and moving apart—occasionally quite quickly.
By CPSChttp://www.cpsc.gov//PageFiles/126654/magnetnpr.pdf

Are any fridge magnets covered by the ban on small, high powered magnets?
Many fridge magnets consist of a magnet which is embedded in another object such as plastic or a plaster mould. These fridge magnets are not subject to this ban. In addition, most fridge magnets are sold
as singles rather than in multiples and would not satisfy the requirement that the product consist of at least two loose or separable magnets.Finally, most fridge magnets are ferrous magnets, which are relatively weak and would be unlikely to reach the magnetic flux measurement specified in the ban.
http://www.productsafety.gov.au/content/item.phtml?itemId=1001029&nodeId=a984c9b0cbe92d797026e55def199f69&fn=Product%20safety%20bulletin%20-%20Ban%20on%20small,%20high%20powered%20magnets.pdf

Children Sleepwear in Australia

Children's sleepwear and limited daywear should comply with AS/NZS 1249:2003 for Australia

Chromium VI in Leather REACH Annex XVII

Chromium based tanning is still an important technical process to convert animal raw hide to leather. Even if chromium VI salts and acids may not be involved in the tanning process nowadays, it is a common phenomenon that chromium III compounds undergo chemical conversion in the tanned leather.

From 1 May 2015, Chromium VI (REACH Annex XVII, Entry 47) should be less than 3 mg/kg in

• Leather articles coming into contact with skin
• Articles containing leather parts coming into contact with the skin

Can Condom enhance sex toy safety?

The sex toys would have skin contact with adult body and the hazard chemicals affecting children could also be applied in adult.

If the sex toys were covered with condoms every times being used, this can keep adults from hazard chemicals also.

The best way is for sure to have hazard chemical -free sex toys instead.

Small Part in Toys?

Sometime, there is grey area in toy safety testing.

Because the textile in the toys are considered as small part, the toys are recalled in Canada.

However in Europe by EN71, the textile materials may not be considered as small part:

Refer link:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/38721r-eng.php#!prettyPhoto