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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