Technical File - Toys (Non Electric)

/ ITEM DESIGNATION
Supplier Reference
Cora Reference
EAN
BRAND
YEAR
Technical File
TOYS (no electric)

1. GENERAL INFORMATION

SUPPLIER / AGENT
Company Name
Contact Name
Postal Address
Phone number
E-mail
Invoicing country
Manufacturing country

2. MAIN CHARACTERISTICS (parts to be filled in by the supplier)

Item description: / Sketch or photo of the product
Do mention imperatively the batch number
on the selling packaging
Age group / All ages
Over 36 months
Weight
Height
Elastomer / Yes No
Magnet / Yes No
If yes, specify where :
Glass / Yes No
If yes, specify where :
Cords, chains / Yes No
If yes, indicate length and thickness :
Monofilament / Yes No
If yes, indicate the length :
Rate of spread of flame / Spread <10 mm/s
10mm/s Spread 30mms
if the toy is concerned
Suction cup / Yes No
If yes, specify the diameter :
Projectile / Yes No
If yes, specify the kinetic energy (J) :
Fragrance / Yes No
Desiccant agent / Yes No
Acoustics / Yes No
If yes, specify the sound level pressure (dB): / What is the mode?
Close-to-the-ear-toy Hand-held toy
Table-top or floor toy Cap firing toy
Percussion toy Pull-along or push toys
Voice toys Wind toys
Toys using headphones or earphones
Squeeze toys Rattles

3. SAFETY STANDARDS

Test Reports less than 24 months on end and assembled products have to be provided
Directive 2009/48/EC
Toy safety directive / The toy safety directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age.
EN 71-1:2014
Mechanical and physical properties
EN 71-2 : 2011 + A1 : 2014 Flammability
EN 71-3 : 2013 +A1 : 2014 Heavy metals
EN 71-4: 2013: Experimental sets for chemistry and related activities
EN 71-5 : 2015 : Chemical toys (sets) other than experimental sets
EN 71-7 : 2014 : Finger paints — Requirements and test methods
EN 71-12:2013 N-Nitrosamines and N-nitrosatable substances / - Toys in elastomers (both natural and synthetic) intended for use by children under 36 months
- Toys in elastomers (both natural and synthetic) intended to be placed in the mouth
- Finger paints intended for use by children under 36 months
EN 71–13:2014: Olfactory board games, cosmetic kits and gustative games
PAHs
REACH Annex XVII – 50. PAHs / Toys, including activity toys, and childcare articles, shall not be placed on the market, if any components that come into direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use, contain more than 0,5 mg/kg (0,00005 % by weight of this component) of any of the listed PAHs.
PHTHALATES
REACH – 51. Phthalates – 52. Phthalates / Phthalates < 1000 ppm (mg/kg)
The test must be carried out on the end and assembled product such it will be sold to cora.
Entry 51: Sum of DEHP, DBP and BBP shall not be greater than 0,1% by weight of the plasticized material.
Entry 52 : Sum of DINP, DIDP and DNOP shall not be greater than 0,1% by weight of the plasticized material
TCEP, TCPP, TDCP (flame-retardants)
Directive 2009/48/EC
Appendix C Directive 2014/79/EU / Only for toys intended for use by children under 36 months
or in other toys intended to be placed in the mouth
Limit value
5 mg/kg (content limit) for each one
Bisphenol A
Directive 2009/48/EC

Appendix C Directive 2014/81/EU

/ Only for toys intended for use by children under 36 months or in other toys intended to be placed in the mouth
Limit value
0,1 mg/l (migration limit) in accordance with the
methods laid down in EN 71-10:2005 and EN 71-11:2005.
PENTACHLOROPHENOL
REACH – 22. PCP
EN 71-9 / PCP < 5 ppm (mg/kg)
Toys in wood intended for use by children under 36 months.
The test must be carried out on the end and assembled product such it will be sold to cora.
FORMALDEHYDE
EN 71-9 / Formaldehyde < 80 ppm (mg/kg)
Toys in wood intended for use by children under 36 months.
The test must be carried out on the end and assembled product such it will be sold to cora.
FORMAMIDE Directive 2009/48/EC
Appendix C Directive (EU) 2015/2115 / Limit value
20 μg/m3(emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content)
Only for toys intended for use by children under 36 months and in other toys intended to be placed in the mouth.
WARNING! APPLICABLE FROM October 28, 2018
Lead
N° CAS 7439-92-1
Modification Annex II, Chapter III, Point 13
Directive 2009/48/EC / Limit value
§ 2 mg/kg in dry materials
§ 0.5 ml/kg in liquid materials
§ 23 mg/kg in scraped-off materials
WARNING! APPLICABLE FROM November 11, 2018
Phenol Directive 2009/48/EC
N° CAS 108-95-2
Project Modification Appendix C
Directive 2009/48/EC / Only for toys intended for use by children under 36 months or in other toys intended to be placed in the mouth
Limit value
§ 10 mg/kg (content) in aqueous formulation in toys
in accordance with EN 71-10:2005 & EN 71-11/2005
§ 5 mg/l (migration limit) in polymeric materials
in accordance with EN 71-10:2005 & EN 71-11/2005
WARNING! APPLICABLE FROM November 26, 2018
Bisphenol A Directive 2009/48/EC
N° CAS 80-05-7
Modification Appendix C
Directive 2009/48/EC / Only for toys intended for use by children under 36 months or in other toys intended to be placed in the mouth
Limit value
0,04 mg/l (migration limit)
in accordance with EN 71-10:2005 & EN 71- 11:2005
Directive 2001/95/EC
EN 14682: Safety of children’s clothing
Cords and drawstring / Only for disguise item in textile
Test only one color.

Food Contact Yes No

All these requirements are obligatory for the toys intended to be in contact with food: plate, glass, fork, knife, spoon, bottle… / If YES, please fill in the “Food Contact specifications for Toy” technical file according to the material (plastic, metal, aluminium, stainless steel, silicon, wood…).

Food imitating product Yes No

Directive 87/357/EC

If YES, French decree 92-985

/ The imitations of the food stuffs must be compliant with
EN 71-1 including the § 5.1 whatever the age grading of the toy.

4. MANUFACTURERS' OBLIGATIONS (Article 4 of 2009/48 EC)

The manufacturer declares that the toy and its accessories comply with the Toy Safety Directive 2009/48/EC.

The manufacturer will ensure that the toys have been designed and manufactured in accordance with the requirements set out in Article 10 and Annex II of the Toy safety Directive 2009/48/EC (Article 4 §1).

Following a reasoned request from the market surveillance authority of a member state, the manufacturer shall provide a translation of the relevant parts of the technical documentation into the language of that member state (Article 21 §3).

Cora non alimentaire will carry out random tests regarding required standards.

5. ATTESTATION

the supplier certifies that the product and its accessories meet hereunder requirements
In case of non-compliance, the supplier will provide cora with laboratory tests for the next orders
Directive 2001/95/EC
General Product Safety Directive (GPSD)
Regulation (EC) 1907/2006
REACH - SVHC - Candidate list
WARNING!
Take into consideration the Substances of Very High Concern (SVHC) listed in the Candidate List when placing the order. / SVHC < 0,1 %
(article + packaging)
The supplier commits himself to transmit the necessary information so as cora can fulfill its commitments relevant to REACH
(MSDS and presence of SVHC).
PHTHALATES : Candidate list - REACH
WARNING!
Take into consideration the phthalates listed in the Candidate list when placing the order. / Phthalates < 1000 ppm (mg/kg)
AZO DYES
REACH Annex XVII - 43. Azo
Textile: EN14362-1/3 / Azo dyes < 30 mg/kg
The test must be carried out on the end and assembled product such it will be sold to cora.
NICKEL Directive 2009/48/EC
Appendix A Directive 2014/84/EC
Toy Safety Directive / Permitted :
§ In toys and toy components made of stainless steel.
§ In toy components which are intended to conduct an electric current.
Organostannic compounds
REACH ANNEX xviI – 20. organostannic / TBT, TPT, DBT, DOT
Limit value:
0,1 % by weight of each organotin
BENZENE
REACH Annex XVII – 5. Benzene / Shall not be used in toys or parts of toys where the concentration of benzene in the free state is greater than 5 mg/kg (0,0005%) of the weight of the toy or part of toy.
DMFu (CAS 624-49-7)
REACH Annex XVII - 61. Dimethyl Fumarate / DMFu < 0,1 mg/kg
On the product itself and desiccant agent if any.
CADMIUM
REACH Annex XVII - 23. cadmium / § Cadmium < 100 ppm by weight for metal beads, metal parts of imitation jewellery articles and hair accessories.
§ Cadmium < 100 ppm by weight for plastic.
§ Cadmium < 1000 ppm by weight of the paint on the painted article.
NICKEL
REACH Annex XVII - 27. nickel
EN 1811 + A1 / EN 12472 + A1 / Metal parts in direct contact with the skin
< 0.5 µg/cm² / week
For post assemblies which are inserted into pierced ears and other pierced parts of the human body
< 0.2 µg/cm² / week
Directive 94/62/EC
Packaging / ∑ (Pb + Cd + Hg + CrVI) < 100 mg/kg
1-2 benzisothiazol-3 (2H)-one (BIT)
N° CAS 2634-33-5
Appendix C Directive 2009/48/EC
Directive (EU) 2015/2116 / Limit value
5 mg/kg in aqueous formulation in toys in accordance with EN 71-10:2005 EN 71- 11:2005
Only for toys intended for use by children under
36 months and in other toys intended to be placed
in the mouth.
WARNING! APPLICABLE FROM November 24, 2017
Reaction mass from (CMI/MI)
5-chloro-2-méthyl-4-isiothiazolin (n°CE 247-500-7)
2-méthyl-2H-isothiazol -3-one (n°CE220-239-6) (3:1)
N° CAS 55965-84-9
Appendix C Directive 2009/48/EC
Directive (EU) 2015/2117 / Limit value
1 mg/kg in aqueous formulation in toys
Only for toys intended for use by children under
36 months and in other toys intended to be placed
in the mouth.
WARNING! APPLICABLE FROM November 24, 2017
5-Chloro-2 methyl-isothiazolin-3 (2H)-one (CMI)
N° CAS 26172-55-4
Appendix C Directive 2009/48/EC
Directive (EU) 2015/2117 / Limit value
0.75 mg/kg in aqueous formulation in toys
Only for toys intended for use by children under
36 months and in other toys intended to be placed
in the mouth.
WARNING! APPLICABLE FROM November 24, 2017
2-Méthyllisothiazolin – 3 (2H)-one (MI)
N° CAS 2682-20-4
Appendix C Directive 2009/48/EC
Directive (EU) 2015/2117 / Limit value
0.25 mg/kg in aqueous formulation in toys
Only for toys intended for use by children under
36 months and in other toys intended to be placed
in the mouth.

6. 4 DOCUMENTS TO BE JOINED TO THE TECHNICAL FILE

All the tests must be made on the end and assembled product such it will be sold to Cora.

- Test reports less than 24 months

- Copy of the markings on the selling packaging

- Copy of the markings on the product

- Copy of the rating label

- Copy of the instruction manual

7. INFORMATION: FUTURE REGULATIONS

a) IN PROGRESS
WARNING! APPLICABLE FROM 2019
Aniline
N° CAS 108-95-2
Project Directive / Limit value
§ 30 mg/kg in textile, paints, chalk
§ 10 mg/kg libre
§ 30 mg/kg in aqueous formulation or glue
WARNING! APPLICABLE FROM 2019
Chrome VI
N° CAS 7440-47-3
Modification Partie III Annex II Directive 2009/48/EC / Limit value
§ 0.0008 mg/kg in dry materials
§ 0.0002 mg/kg in liquid materials
§ 0.0094 mg/kg scraped-off materials
b) IN PREPARATION
WARNING! APPLICABLE END 2018
Formaldehyde
N° CAS 50-00-0
Project Directive / Limit value
§ 30 mg/kg (migration limit) textile-paper
§ 0.1ppm (emission limit) wood
§ 6 mg/kg (detectable minimum) in aqueous formulation in toys
Supplier’s stamp / Name and title of the signatory & signature / Date

ISO/SQ/TF/NON ELECTRIC TOYS/31.08.10/MAJ 24.05.17/Rev 25 Page 2/7