Chemical Compliance the Bill Of Material Approach
(Compliance is mandatory – testing is not) Contents Introduction Declaration of Conformity Bill of Materials Using the BOM Chemical Management Systems Appendices A Legislation and Standards Relating to the Use of Hazardous Chemicals
and Chemical Compounds Used in Toys B Other bill of material formats & details C Blank BOM
Introduction The wave of regulations coming out of Europe (e.g. Restriction Of Hazardous Substances (RoHS), EN71-9, 10, 11 etc) means that demonstrating compliance by product testing is not practical (it is complicated, time-consuming, unnecessary and costly). Neither is it the most effective way of showing continuous compliance. This is recognised by the Commission, CEN and enforcement authorities as the principle of ‘’verification and assurance of conformity” (supplier’s self-declaration/certification supported by the appropriate documentation) and is embodied within EN71-9 Annex B. In light of this, it seems reasonable that the same approach can be applied to all restricted chemicals used in toys. This document aims to guide toy manufacturers and importers through a procedure that will allow them to offer other means of evidence of compliance with chemical based legislation. It outlines how this may be achieved using a ‘Bill of Materials’ (BOM) as a point of reference. The BOM can then be used to determine what actions are necessary to assure a producer/importer of product compliance and so sign a declaration of conformity. Adopting this guidance requires technical knowledge and experience to assess the risks adequately and identify the appropriate controls and documentation required. If sufficient expertise is not available in-house, one should consider using external expertise. This document applies only to chemical legislation; it does not cover other legislation (e.g. physical, electrical and flammability requirements). Declaration Of Conformity A declaration of conformity is a document a producer/importer signs stating that a product or product range complies with relevant regulations/standards. A declaration of conformity is a recognised legal document and has international normative standards covering its format and contents. The BTHA have issued guidance on creating a declaration that can be found at: http://www.btha.co.uk/btha_memberupload/dynamic/documents/declaration _conformity.doc
Bill of Materials In simple terms, this is a list of the parts and components that a factory needs to be able to make the product. Producers/importers must obtain a BOM for each product. There are many formats of BOM (e.g. main frame computer systems, personal computers, hand-written etc), some are simple and some have a great level of detail but for this purpose a BOM should have at least:
1. Part description. 2. Material it is made from. 3. Total weight of it in product. 4. Is it a ‘purchased item’? (i.e. it comes from another supplier and is not
‘made’ by the factory) As an example a very simple ‘Bill of Materials’ for a pen on a blister card may look like the following:-
Product name: Toy Pen Item no: 12344 Manufacturer: Toy Maker PLC
Part number Description Material Total weight in product (grams)
Purchased item?
00345 Final consumer unit – pen on blister card
17 No
00001 Blister card Printed cardboard
5 Yes
0002A Formed blister 3 No 0002B Blister sheet PET Yes
0003A Pen top 2 No 0003B Plastic for pen top ABS Yes
0004A Pen body 5 No 0004B Plastic for pen body Polycarbonate Yes 0004C Red tampo Tampo print ink 0.05 yes
0005A Pen cap 1 No 0005B Plastic PVC Yes 0005C Yellow colourant Yes
0006A Pen refill 1 Yes
• There is a blank copy of this simplified type of BOM in Appendix. • Please see Appendix B for examples of other ‘BOM’ formats that may be useful.
Using the BOM There are 4 steps that should be used to assess product compliance using the BOM. Step 1: Review the Bill of Materials Review the ‘Bill of Materials’ to determine the regulations and standards that each part would need to comply in order for the finished product to comply e.g.:-
1. EN71 part 3 2. Total cadmium 3. Phthalates Etc
If sufficient expertise is not available in-house, one should consider using external expertise. Examples of the use of the parts list when determining applicability
Table 1 – Table showing applicability of standards/directives
Material EN71 Part 3 Cd Cosmetic Regs
Packaging Waste Regs
EN71 Part 9 Phthalates etc
Formed blister PET N/A √ N/A √ N/A N/A
Pen top PVC √ √ N/A N/A √ √ Yellow colourant Unknown √ √ N/A N/A √ √
Pen refill Various parts √ √ N/A N/A √ √
Pen body ABS √ √ N/A N/A √ √
Red tampo Tampo Ink √ N/A N/A N/A N/A N/A
Consider the type and age appropriateness of the product as some product types and components may not be included within the scope of particular regulations (e.g. the requirements for textiles in EN71: Part 9 only apply to toys for children under 3 years) Step 2: Assess the risk of non-compliance Consider the materials being used to manufacture the components and the likelihood for non-compliance with the applicable legislation identified in step 1. Restricted chemicals are not present in all materials and therefore may not require assessment or testing. Similarly substances whose known formulation does not contain the restricted chemicals for applicable standards will also not require further action. The following table shows how the risk of non-compliance can be assessed for each part. It clearly demonstrates that some requirements, although applicable, are not necessary to examine, as the risk of non-compliance is low.
If sufficient expertise is not available in-house to assess the risk, one should consider using external expertise.
Table 2 – Table showing risk of non compliance
Material EN71 Part 3 Cd Cosmetic Regs
Packaging Waste Regs
EN71 Part 9 Phthalates etc
Formed blister PET Low Low
Pen top PVC Low High Use BTHA Guide High
Yellow colourant Unknown *1 Unknown*1 Unknown*1 Unknown*1 Unknown*1
Pen refill Various parts*2 Various*2 Various*2 Various*2 Various*2
Pen body ABS Low Low Low Low Red tampo Tampo ink High Etc
*1 The exact make up of the colourant is required in order to assess the risk. *2 As the refill is made up of several parts each part needs to be assessed for risk individually. E.g. the casing will need to be considered as a polymeric material and the ink itself will require a different assessment. In this case the full formulation is required as it is likely that a full toxicological assessment will be required. Important note: the risk levels stated above are for illustration purposes only and may not be accurate. They must not be used to determine risk for other products. Step 3: Documentation Determine the documentation required based on the risk of non-compliance as shown in step 2 Appropriate documentation includes:
• Test report (showing compliance to the identified standards from above)
• Declaration of Conformity (DOC) from the supplier • Toxicological Risk Assessment (TRA)
Using the part of the pen refill as an example, it would seem sensible to accept a DOC for the EN71: Part 3 for the polymers and to obtain a TRA for the ink. Step 4: Validation The key to any good QA system is making sure it works. This could be as simple as taking a random product or material and carrying out due diligence testing or it could be as complex as conducting a full review of the manufacturer’s chemical management system.
Chemical Management Systems These guidelines cover only one element of a chemical management system. To maintain continuous compliance and ensure that restricted chemicals do not end up in finished products, the manufacturer needs to have in place systems and processes to manage the purchase of materials. A chemical management system would ensure that raw materials and components do not fail the requirements “at source.” A chemical management system may include detailed purchase specifications, material supplier management systems, raw material and due diligence testing. Such systems may require an audit to validate them (there are schemes available to help with this).
APPENDIX A – Legislation and Standards Restricting the use of Hazardous Chemicals and Chemical Compounds Used in Toys
o EN71- Part 3:1995 Specification for the migration of certain elements plus amendments
o Total Cadmium – 91/338/EEC o Cosmetics Directive – 76/768/EEC o Packaging Waste Directive – 94/62/EEC (amended by Directive
2004/12/EEC o Battery & Accumulators Directive 91/157/EEC (will be replaced by
2006/66/EC in September 2008) o EN71- Part 9:2005 Organic Chemical Compounds – Requirements o Phthalates Directive – 2005/84/EC o Restriction of Hazardous Substances Directive (RoHS) – 2002/96/EC o Azo Dyes 76/769/EEC (EN14362)
This list is not exhaustive and may be subject to change.
Appendix B – Other Bill of Materials Formats and Details In simple terms, a product consists of assemblies, sub-assemblies, purchased parts and materials. This can be shown visually in a product structure format, as shown in figure 1. Using this method:
o The top level is the finished product. o The bottom level of each path is a purchased part or raw material. o The intermediate levels are the manufactured parts, sub-assemblies or
assemblies. Although relatively simple, this example of a diecast car and trailer demonstrates a number of points:
o How raw materials are converted into manufactured parts (e.g. die cast
or injection moulded components). o How two or more parts can form sub assemblies, which in turn form
assemblies at higher-levels. The top level is the finished product o How the weight at each level is the sum of the weights of the level
below. o How the same material can be used in a different path in the structure
(e.g. plastic master batches).
Bill of Materials Format Although a tree structure is a useful way to describe how the parts of a product relate to each other, the normal method of describing a product is a bill of materials (BOM). Basically consisting of a list of parts, a BOM is an essential part of the design and manufacture of any product. The BOM should perform the same function as the tree structure. The top level describes the finished product with its immediate list of parts and sub-assemblies listed beneath. The BOM of these parts then contains its own list of parts and sub-assemblies. This increasing level of detail continues for all parts or sub-assemblies until it reaches the bottom level of each path where the parts or raw materials are bought in from another supplier. The BOM (figure 2) shows the same the diecast car and trailer. As with the product structure view, each manufactured part, sub-assembly or assembly has listed beneath it the parts or raw materials that go into its manufacture. However, to distinguish the manufactured part from its immediate components, these are shown indented and in a light print.
Like the hierarchical format:
o The top level is the finished product. o The bottom level of each path is a purchased part or raw material.
However, as this is not obvious in a BOM format, a column has been added to show that the part or material is bought from another supplier.
A BOM can define products as they are designed, as they are manufactured, as they are ordered, as they are built, or as they are maintained. There are different types of BOM dependent upon the purpose for which they are intended. For the purpose of this document, the BOM is required to identify the chemical compliance requirements for the product and what needs to be available to demonstrate compliance. To define this, the last three columns have the purchasing specification reference, or the test documentation and its date. These optional columns are shown in blue.
Pac
ked
Car
&
Tra
iler
0000
1(3
75 g
ram
s)
Pac
ked
Car
&
Tra
iler
0000
1(3
75 g
ram
s)
Ass
embl
ed
Car
0000
2(2
00 g
ram
s)
Ass
embl
ed
Car
0000
2(2
00 g
ram
s)
Pai
nted
Car
B
ody
0000
4(1
00 g
ram
s)
Pai
nted
Car
B
ody
0000
4(1
00 g
ram
s)
Ret
ail P
ack
0001
1(2
5 gr
ams)
Ret
ail P
ack
0001
1(2
5 gr
ams)
Die
-Cas
t Car
B
ody
0000
6(9
9.75
gra
ms)
Die
-Cas
t Car
B
ody
0000
6(9
9.75
gra
ms)
Zinc
1000
3(9
9.75
gra
ms)
Zinc
1000
3(9
9.75
gra
ms)
Red
Pai
nt10
002
(0.2
5 gr
ams)
Red
Pai
nt10
002
(0.2
5 gr
ams)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e W
ire10
006
(4 g
ram
s)
Axl
e W
ire10
006
(4 g
ram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Ass
embl
ed
Trai
ler
0000
3(1
50 g
ram
s)
Ass
embl
ed
Trai
ler
0000
3(1
50 g
ram
s)
Dec
orat
ed
Trai
ler B
ody
0000
10(5
0 gr
ams)
Dec
orat
ed
Trai
ler B
ody
0000
10(5
0 gr
ams)
Pla
stic
M
ould
edTr
aile
r Bod
y00
013
(49.
75 g
ram
s)
Pla
stic
M
ould
edTr
aile
r Bod
y00
013
(49.
75 g
ram
s)
Blu
e In
k10
008
(0.2
5 gr
ams)
Blu
e In
k10
008
(0.2
5 gr
ams)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e W
ire10
006
(4 g
ram
s)
Axl
e W
ire10
006
(4 g
ram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(49.
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(49.
5 gr
ams)
Red
Col
oura
nt10
007
(0.2
5 gr
ams)
Red
Col
oura
nt10
007
(0.2
5 gr
ams)
x2x2
x2x2
x1x1
x1x1
x1
x1x1
x1
x1x1
x1
x1
x1x1
x1
x1
x1x1
x1
x1x1
x1
x1
x1x1
x1
Pac
ked
Car
&
Tra
iler
0000
1(3
75 g
ram
s)
Pac
ked
Car
&
Tra
iler
0000
1(3
75 g
ram
s)
Ass
embl
ed
Car
0000
2(2
00 g
ram
s)
Ass
embl
ed
Car
0000
2(2
00 g
ram
s)
Pai
nted
Car
B
ody
0000
4(1
00 g
ram
s)
Pai
nted
Car
B
ody
0000
4(1
00 g
ram
s)
Ret
ail P
ack
0001
1(2
5 gr
ams)
Ret
ail P
ack
0001
1(2
5 gr
ams)
Die
-Cas
t Car
B
ody
0000
6(9
9.75
gra
ms)
Die
-Cas
t Car
B
ody
0000
6(9
9.75
gra
ms)
Zinc
1000
3(9
9.75
gra
ms)
Zinc
1000
3(9
9.75
gra
ms)
Red
Pai
nt10
002
(0.2
5 gr
ams)
Red
Pai
nt10
002
(0.2
5 gr
ams)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e W
ire10
006
(4 g
ram
s)
Axl
e W
ire10
006
(4 g
ram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Ass
embl
ed
Trai
ler
0000
3(1
50 g
ram
s)
Ass
embl
ed
Trai
ler
0000
3(1
50 g
ram
s)
Dec
orat
ed
Trai
ler B
ody
0000
10(5
0 gr
ams)
Dec
orat
ed
Trai
ler B
ody
0000
10(5
0 gr
ams)
Pla
stic
M
ould
edTr
aile
r Bod
y00
013
(49.
75 g
ram
s)
Pla
stic
M
ould
edTr
aile
r Bod
y00
013
(49.
75 g
ram
s)
Blu
e In
k10
008
(0.2
5 gr
ams)
Blu
e In
k10
008
(0.2
5 gr
ams)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Ass
embl
ed
Bas
e00
005
(100
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Mou
lded
W
heel
0000
9(8
gra
ms)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e A
ssem
bly
0000
8(2
0 gr
ams)
Axl
e W
ire10
006
(4 g
ram
s)
Axl
e W
ire10
006
(4 g
ram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Mou
lded
Bas
e00
007
(60
gram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Pla
stic
Mas
ter
Bat
ch10
004
(59.
75 g
ram
s)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Bla
ck
Col
oura
nt10
005
(0.2
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(7.7
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(49.
5 gr
ams)
Pla
stic
Mas
ter
Bat
ch10
004
(49.
5 gr
ams)
Red
Col
oura
nt10
007
(0.2
5 gr
ams)
Red
Col
oura
nt10
007
(0.2
5 gr
ams)
x2x2
x2x2
x1x1
x1x1
x1
x1x1
x1
x1x1
x1
x1
x1x1
x1
x1
x1x1
x1
x1x1
x1
x1
x1x1
x1
Figure 1: Product Structure Diecast Car and Trailer
Figure 2
Bill Of Materials Product Name: Die Cast Car and Trailer Item Number: DC123456 Age: 4+ Factory Name: Any factory; PRC
Part Number Description Material Purchase Item
Compliance Requirements
Total weight in product (grams) Purchase
Specification Documentaion Date
00001 Packed Car & Trailer 375 00002 Assembled Car 00003 Assembled Trailer 10001 Retail Pack
10001 Retail Pack Card 25 Y PS00001 00002 Assembled Car
200
00004 Painted Car Body 00005 Assembled Base
00004 Painted Car Body 100 00006 Die-Cast Car Body 10002 Red Paint
00006 Die Cast Car Body 99.75 10003 Zinc
10003 Zinc Zinc Alloy 99.75 Y PS12345
10002 Red Paint 0.25 Y PS246810 EN71 Part 3 01/01/2007
00003 Assembled Trailer 150
00010
Decorated Trailer Body
00005 Assembled Base
00010 Decorated Trailer Body 50 00013
Plastic Moulded Trailer Body
10008 Blue Ink
10008 Blue Ink 0.25 Y PS13579 EN71 Part 3 - 9 31/12/2006
00013 Plastic Moulded Trailer Body 49.75
10004 Plastic Master Batch
10007 Red Colourant
10007 Red Colourant 0.25 Y PS987654
00005 Assembled Base 200
00007 Moulded Base
00008 Axle Assembly
00007 Moulded Base 120
10004 Plastic Master Batch
10005 Black Colourant
10004 Plastic Master Batch PP 231 Y PS12356 EN71 Part 3 01/06/2005
10005 Black Colourant 2.5 Y PS986532
00008 Axle Assembly 80
00009 Moulded Wheel
10006 Axle Wire
00009 Moulded Wheel 64
10004 Plastic Master Batch
10005 Black Colourant
10006 Axle Wire S/S Wire 16 Y PS951357
Field Explanation Part Number The sku of the packed toy (top level), sub assemblies, manufactured
components, raw material or bought in components • When the item is manufactured in the factory, the sku’s of each
of the materials or components of the manufactured part is shown immediately below its parent and indented.
• When the item is a purchased part, there will be no components of that part
Mandatory
Description The description packed toy (top level), sub assemblies, manufactured components, raw material or bought in components. • When the item is manufactured in the factory, the description of
the materials or components of the manufactured part is shown immediately its parent below and indented.
• When the item is a purchased part, there will be no components of that part
Mandatory
Material Type The type material used. This need only be for a purchased part or raw material*1
Mandatory
Total Weight in product (grams)*²
The total weight each sub assembly, manufactured component, raw material of bought in component the finished product
Mandatory
Purchase item Whether the item is bought in by the factory Mandatory Compliance Requirements – Optional Purchase Specification
The purchase specification reference used when the purchasing department buys in the purchased part or raw material
Documentation The documentation available to demonstrate compliance. This may be:
• Test certificate for the material or part • Declaration of Compliance for the material or part. A DoC
must have supporting documentation to support its credibility
Date Date of the test report or DoC
*1 If the material being purchased is compound (such as inks, cosmetics, food etc) then these must be supported with their own Bill of Material or TRA (Toxicological Risk Assessment) with a breakdown of the compounds included. *2 The weight of the item in the finished product. This may be acceptable as a percentage of the weight in the finished product.
Appendix C – ‘Blank’ BOM Product Name: Item Number: Manufacturer: Item number Description Material Total weight
in product (grams)
Purchased item ?
