Technical Documentation Bill of Materials Enhanced Format Revised Toy Safety Directive 2009/48/EC

Size: px
Start display at page:

Download "Technical Documentation Bill of Materials Enhanced Format Revised Toy Safety Directive 2009/48/EC"

Transcription

1 Technical Documentation Bill of Materials Enhanced Format Revised Toy Safety Directive 2009/48/EC Contents 1. Obligations of Economic Operators 2. Introduction 3. Why have a standard BoM format? 4. BoM format 4.1 Simple format 4.2 BoM showing breakdown of parts and materials 4.3 Full BoM for safety assessment 4.4 Key to each level 5. Alternative BoM templates 5.1 Printed template 5.2 Excel template 5.3 Interactive Excel template Record of Amendments Version Date Amendment Section/page affected First published Completely revised New format LEGAL NOTICE This document contains guidance only. It is intended to explain obligations and how to fulfil them. However readers are reminded that the text of the original regulation, directive or standard is the only authentic legal reference and that the information in this document does not constitute legal advice. The British Toy and Hobby Association does not accept any liability with regard to the contents of this document.

2 1. Obligations of Economic Operators Obligation Manufacturer Importer Distributor Article 4 Ensure toys comply Article 6 Place only Article 7 Take due with essential safety compliant toys care requirements on the market Draw up Technical Documentation and carry out the conformity and safety assessments. A4(2) A21 A18 A19 Obligated A6(2) Ensure it is done No Obligation A BoM forms a part of the Technical Documentation. A Manufacturer outside of the EU can appoint by a written mandate an Authorised Representative. The Authorised Representative shall perform all the tasks in the mandate but the drawing up of the technical documentation can NOT form part of this mandate. This remains the responsibility of the Manufacturer. 2. Introduction The revised Toy Safety Directive (TSD) (2009/48/EC) was adopted by the European Parliament on 18 December 2008 and the final text was formally adopted and published in the Official Journal of the European Union (OJ) on 30 June Article 4 of the revised TSD details the Technical Documentation required to be kept for each toy placed on the market and this includes a list of components and materials used in the toy.. Such a listing in manufacturing industry is more commonly known as a Bill of Materials (BoM). This BTHA guidance describes a recommended format for a BoM that should be kept in the technical documentation. However, the BTHA recognises that the level of detail required in a BoM may vary according to the circumstances of the member, its suppliers and the type of product under scrutiny. The BTHA, therefore, have provided three levels of BoM format for use in different circumstances and these guidelines describe these three formats. 3. Why have a standard BoM format? The TSD requires that manufacturers keep a detailed description of the design and manufacture of the toy. This description will include technical drawings and a list of the components and materials used in the toy. This list is commonly referred to as the Bill of Materials (BoM) and should include purchased parts, sub assemblies and raw materials. As defined in the economic operators guide, this must be produced by the manufacturer: In simple terms, the prime reason to include a BoM in the Technical Documentation is to fulfil Article 4 and Annex IV(a) of the Toy Safety Directive. However, other parts of the TSD restrict specific chemicals and requires that every toy undergoes a safety assessment, including a chemical safety assessment. And as toys are not immune from other legislation, such as REACH and RoHS which have their own chemical restrictions, these Directives should also be considered. A BoM is a useful tool in evaluating whether the chemical requirements of these Directives are being met. A BOM shows the intended substances of the product and is one of the tools that can help show that restricted chemicals are not a part of the product design. Used with proper manufacturing control procedures, as outlined in the BTHA Conformity Assessment Guide, testing costs can be significantly reduced. All manufacturers use BoMs in one form or another. These are most often used for manufacturing or costing purposes but not to evaluate compliance to product to safety legislation. There is no standard format and many of the versions being used in toy factories make it difficult for small companies to obtain a suitable BoM. Hence many companies, large and small, have concluded that a standardised format it would give uniformity and familiarisation that would allow evaluation of the product to safety legislation.

3 The following is suggested guide for companies to follow. 4. BoM format The BTHA suggestion for a BoM is shown below and has three levels of detail: Level Description 1 This is a very simple BoM format that is basically a simple list of parts in the toy This format would be suitable for simpl e products (i.e. products without substances, preparations or formulations). This is considered to be the minimum that any toy manufacturer or toy importer should include in the technical documentation to meet the requirements of Article 4 and Annex IV (a) of the TSD. 2 BoM showing the breakdown of the parts and materials used in the product This format breaks down the products to individual parts and materials delivered to the factory. These may include as single line entries in the BoM: - Formulated gels or liquids that are pre-mixed - Coloured plastic granules that are pre-mixed - Pre-moulded plastic components - Electronic sub-assemblies The level 2 BoM does not show the breakdown these parts and materials to their constituent substances 3 Full BoM format for full chemical safety assessment This format breaks down the product to substance level and allows the concentration levels to be calculated. Levels 2 and 3 add detail to the preceding levels. Each allows for a chemical safety assessment but the higher levels allow for a more accurate assessment. This is the topic of the BTHA Chemical Safety Assessment Guide. However it should be remembered that, whatever level of BoM is used, it is the intended content of the product that is shown.

4 4.1 - Simple Format Bill of Materials / Bill of Substance Product Name: Factory Name: Item Number: Date: Issue Number: Part No Description Materials Method of Compliance (SDS, Test, DoC, TRA) The information required is: Part Number this is a unique number within the product. There is no predefined format. Description description of the part. Material - a description of the material of the part. Many parts will be composite materials or assemblies of other parts (for instance electronics). The material should be as detailed as possible. For instance, plastics should name the polymer type (e.g. PP, PET etc) and should not just say plastic. Any decoration should be declared (e.g. paint, tampo print etc). This will enable a user to apply simple risk evaluation to determine whether further details or testing is required. Method of compliance - used by the manufacturer / factory to determine whether the part is in compliance. This could be a Declaration of Conformity (DoC); Toxicology Risk Assessment (TRA); Safety Data Sheet (SDS) or batch Test. This format allows for a chemical safety assessment using a risk based approach, as described in the BTHA Chemical Safety Assessment Guide. The BTHA format is available as a full page template at the end of this guideline. This can be printed out and used to enter BoM information. Alternatively, an Excel version is available from the BTHA website.

5 4.2 - BoM showing the breakdown of the parts and materials Bill of Materials / Bill of Substance Product Name: Factory Name: Item Number: Date: Issue Number: Method of Compliance (SDS, Test, DoC,TRA) Part No Description Materials Source Amount in CAS Number EINICS Number Sub Part Nos finished product SDS (YorN) This is the same as level 1 with the addition of: Sub part numbers - these are the part numbers substances/materials that make up the part number above. The sub part numbers are indented to identity their status and this format is often referred to as an indented BoM. Source - indicating the type of part: o M = Manufactured or Made in factory o P = Purchased item or component o R = Raw Material o O = Other (should be specified) Amount in finished product - the amount of the part or material in the finished part. This can be quantity, weight, volume etc. It is not used in any calculation. CAS and EINECS numbers - these numbers allow the reviewer to establish if there are any hazardous chemicals in the toy. The concentration cannot be determined without further information. SDS supplied - for a material the SDS can be used to establish whether a hazardous chemical is present if a CAS number is not supplied. Again, the concentration cannot be determined without further information. The shaded columns are not required unless a substance is R (raw Material) and has a CAS or EINICS number. This format shows the materials used in the product and should allow the reviewer to conduct a chemical safety assessment. However, further analysis will be required to evaluate concentration levels, as described in the BTHA Chemical Safety Assessment Guide. The BTHA format is available as a full page template at the end of this guideline. This can be printed out and used to enter BoM information. Alternatively, an Excel version is available from the BTHA website.

6 4.3 - Full BoM format for safety assessment Bill of Materials / Bill of Substance Product Name: Factory Name: Item Number: Date: Issue Number: Method of Compliance (SDS, Test, DoC,TRA) Part No Description Materials Source Qty Wt of Comp wt % of materials Matl weight in CAS Number EINICS Number SDS Purchase Other features Photo Sub Part comp in finished in the finished (YorN) Specification Nos product component product (YorN) This is the same as level 2 with the addition of: Qty of parts or components in the finished product Wt of comp - component or part weight in grams. Unlike the 'Amount' field in level 2, I have asked for weight in grams for this field as it then allows the % of materials in finished product to be calculated based on the overall toy weight. This can be used in REACH. Comp wt in finished product - this is the product of the above two fields and is automatically calculated. % of materials in the component - used to determine the composition of formulations or mixtures (such as polymer mixtures). The total must add to 100% (although there is no check at the moment.) Material weight in finished product - this is calculated from the component weight in the product and the % of substance in the mixture. It is automatically calculated. Purchase Specification - this indicates whether there is a specification in place to purchase the material. Among other thinks, this would define the legal standards the materials must meet (e.g. TSD, REACH, RoHS etc.). This would be used when placing orders and can be used for multiple suppliers. It can eliminate the need to specify the factory's suppliers and does not restrict the factory to one supplier. Other features - this is a non defined field that can be used to describe the part, component or material. It could be used to describe the part as electronic (therefore requiring RoHS); to define the part as 'not accessible' etc. Photo - an optional field that can hold an image of the part or (better still) a hyperlink to a photo file. The shaded columns are not required unless a substance is R (raw Material) and has a CAS or EINICS number. This format shows all the materials and parts in the toy and the weights and percentages of each substance in a mixture and in the whole toy. These can be used to conduct a full chemical safety assessment, including concentration levels, as described in the BTHA Chemical Safety Assessment Guide. The BTHA format is available as a full page template at the end of this guideline. This can be printed out and used to enter BoM information. Alternatively, an Excel version is available from the BTHA website.

7 Key to each level Each level of BoM builds on the preceding level. To identify what is in each level, the column headings have been colour coded. This code is shown below. Level 1 BoM format Level 2 BoM format Level 3 BoM format 5. Alternative BoM templates The description above describes the BTHA format for three levels of a BoM format. 5.1 Template Full page templates of each of the three formats are included at the end of these guidelines. These can be printed and used to enter the BoM information. 5.2 Excel Template Excel templates are available from the BTHA web site. 5.3 Interactive Template Available on the BTHA web site members area are Excel spreadsheets that have some interactive features that helps the user prepare a BoM. These features include: Unshading columns (CAS Number/SDS/% Material etc) where these are appropriate (level 2 and 3) Automatically calculating % materials in component and weight material in finished product (level 3). Automatically calculating the weight of finished product (level 3)

8 Bill of Materials / Bill of Substance Product Name: Factory Name: Item Number: Date: Issue Number: Part No Description Materials Method of Compliance (SDS, Test, DoC, TRA)

9 Bill of Materials / Bill of Substance Product Name: Factory Name: Item Number: Date: Issue Number: Method of Compliance (SDS, Test, DoC,TRA) Part No Description Materials Source Amount in CAS Number EINICS Number Sub Part Nos finished product SDS (YorN)

10 Blank Page