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EN71-3 Testing

Compliance with EN 71-3:2013 will offer a presumption of conformity to the migration of certain elements requirements of the Toys Safety Directive 2009/48/EC, which take effect from 20 July 2013.
EN 71-3:2013 already includes the new lower migration limits for barium than those originally published in the Directive. This interim discrepancy has now been resolved through a further amendment to the Directive by Regulation (EU) No 681/2013.
he new chemical requirements of the EU Toys Safety Directive, which take effect from 20 July 2013.  The main changes and issues are as follows:
The main changes and issues are as follows:
Toy materials are now divided into three categories, as follows, based on their type, which determines the extent to which they may be ingested by the child.  (See Table 1 overleaf.)
- Category I - Dry, brittle, powder-like or pliable materials
- Category II - Liquid or sticky materials
- Category III - Scraped-off materials
Testing now includes 19 elements (or rather 17 different elements, with chromium (III) and (VI), along with both tin and organic tin counted twice).
The original 8 elements are retained (chromium, now being split as the two oxidation states above), along with another 9 different elements.
Migration limits have been revised, with many reduced (see Table 2 overleaf).
Barium migration limits have been reduced further from those in the Directive (with another reduction in the lead limits expected in due course).
The migration limits for chromium (VI) in Categories I and II toy materials are too low to be measured directly by the new EN 71-3 method.  Hence other means will have to be used to demonstrate compliance.
The large analytical correction factor applied has been deleted.
- Under the previous version, only the adjusted analytical result was used to verify compliance.  That is, for a toy material to be deemed non-compliant, the analytical result had to exceed the migration limit by such a considerable margin that it still exceeded the migration limit after subtraction of the analytical correction factor (which was 30 %, 50 % or 60 %, per each element).
Laboratories now have to determine their measurement uncertainty and use it to interpret whether their analytical result shows compliance with the migration limit.
- The margin by which the analytical result could now “exceed”the migration limit before its deemed non-compliant will be drastically reduced.  That is, assuming that a lab’s measurement uncertainty is significantly lower than the former 30 % to 60 % analytical correction factor.
Table 1 - Toy Material Categories

Criteria

Toy Materials

 

Category

Category I

Category II

Category III

 

 

Toy Material Type

Dry, brittle, powder-like or pliable materials

Liquid or sticky materials

Scraped-off materials

 

Definition

Solid materials which may leave residues on the hands

Fluid or viscous materials which can be ingested or have skin contact

Solid materials which can be ingested by biting, tooth scraping, sucking or licking

 

Examples

1. Compressed paint tablets
2. Colouring pencil cores
3. Chalk
4. Crayons
5. Other solid materials intended to leave a trace
6. Pliable modelling clays
7. Plaster of Paris

1. Finger paints
2.Paints, varnishes, lacquers
3. Ink in pens
4. Liquid adhesives
5. Glue sticks
6. Slimes
7. Bubble solutions
8. Other accessible liquids

1. Coatings (e.g., paints, varnishes, lacquers, inks, polymers, etc.)
2. Plastics, rubbers, silicones and other polymeric materials
3. Paper and paper board
4. Textile materials
5. Glass, ceramic, metallic materials
6. Wood, fibre board, hard board, bone, leather, etc.

 

Assumed ingestion by the child

100 mg/day

400 mg/day

8 mg/day

Table 2 - Migration Limits

Element

Migration Limits  (mg/kg)

Category I
Dry, brittle, powder-like or pliable materials

Category II
Liquid or sticky materials

Category III
Scraped-off materials

Aluminium (Al) 

5,625

1,406

70,000

Antimony (Sb) 

45

11.3

560

Arsenic (As) 

3.8

0.9

47

Barium (Ba) 

1,500

375

18,750

Boron (Bo)

1,200

300

15,000

Cadmium (Cd)

1.3

0.3

17

Chromium (III) (Cr III) 

37.5

9.4

460

Chromium (VI) (Cr VI) 

0.02

0.005

0.2

Cobalt (Co)

10.5

2.6

130

Copper (Cu)

622.5

156

7,700

Lead (Pb)

13.5

3.4

160

Manganese (Mn)

1,200

300

15,000

Mercury (Hg)

7.5

1.9

94

Nickel (Ni)

75

18.8

930

Selenium (Se) 

37.5

9.4

460

Strontium (Sr)

4,500

1,125

56,000

Tin (Sn)

15,000

3,750

180,000

Organic tin (Otc) 

0.9

0.2

12

Zinc (Zn) 

3,750

938

46,000

Toy Safety Directive (EN71) Testing
What is the Toy Safety Directive?
The Toy Safety Directive 2009/48/EC is the European legislation regarding the safety of toys; by which “toys” are any product or material designed or intended whether or not exclusively for use in play by children under 14 years of age.
The main requirements for toy safety testing are that toys must:
satisfy safety requirements (termed the ‘essential safety requirements’)
bear the CE marking;
bear the required name and address details;
be accompanied by warnings where necessary.
In addition, information must be maintained for inspection by enforcement authorities.
What are the Toy Safety Testing Standards?
The EN 71 series of European harmonised toy safety testing standards produced by CEN has been transposed into the British Toy Standards BS EN 71. These are the ‘relevant national toy standards’ for the purpose of toy safety.
Various parts to BS EN 71 have been published. They deal with mechanical and physical properties, flammability requirements, migration of certain elements (i.e. permitted levels of lead, cadmium, etc.), experimental sets for chemistry and related activities, chemical toys other than experimental sets and a pictogram for age warning labeling.
 Who is affected by the Toy Standards Directive?
Toy Safety Testing Regulations apply to manufacturers, importers, retailers, hirers and other suppliers of new and second-hand toys – that is, anyone supplying toys in the course of any business. Toys distributed free of charge in the course of business are also covered.
 How do I comply with the Toy Standards Directive?
In order comply with the Toy Standards Directive, the primary requirement is that toys meet the essential safety requirements of the Directive. In order to do this, toys must either be manufactured in accordance with harmonised standards, or must be type tested by a notified body in order to demonstrate that they comply with the essential requirements of the Directive.
Additionally, toy safety testing requires that the manufacturer should do the following:
Create a declaration of conformity and affix the CE logo to the product
Maintain a technical file containing certain information about the toys (for a period of 10 years after the toy has been placed on the market)
Ensure procedures are in place for series production to remain in conformity. If appropriate for the toy, manufacturers should also carry out sample toy safety testing and, if necessary, keep a register of complaints of non-conforming toys
Ensure the toys bear a type, batch, serial or model number (or if not possible then include the information on the packaging or an accompanying document)
Indicate on the toy their name, registered trade name or registered trade mark and the address at which they can be contacted (or if not possible then include the information on the packaging or an accompanying document)
Supply appropriate instructions and safety information in an appropriate language
Take appropriate corrective actions to deal with toys they have placed on the market that they consider or have reason to believe are not in conformity with the relevant Community harmonisation legislation.
 Why do I need to comply with the Toy Standards Directive?
Failure to comply with the Toy Standards Directive can result in compulsory measures ranging from withdrawal of products from the market and import rejections through to fines and even imprisonment.

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