Chemical Safety Assessment CMR Guidance Revised Toy Safety Directive 2009/48/EC Contents 1. Obligations 2. Introduction 3. Overview 4. Definitions 5. The Two Approaches Materials Approach using the Toyograph CAS Number Approach Annex 1 How to use the European Chemical Substances Information System Record of Amendments Version Date Amendment Section/page affected 1 22/7/2013 First Published 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.
1. Obligations of Economic Operators Obligation Manufactuer Importer Distributor Authorised Representative Carry out the conformity assessment A4(2) A19 Obligated A6(2) Ensure its done No obligation No obligation Carry out the Safety Assessment A4(2) A18 Obligated A6(2) Ensure its done No obligation No obligation To establish your company s role under the revised Toy Safety Directive please see the separate BTHA guidance on the Obligations of Economic Operators, which should be read first. 2. Introduction The revised Toy Safety Directive (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 2009 The Toy Safety Directive requires that toys and components of toys shall not contain substances classified as CMR - Carcinogenic, Mutagenic, or toxic for Reproduction - (CLP Regulation (EC) 1272/2008 classification, labelling and packaging of substances). Substances of Categories 1A, 1B or 2 shall not be used with certain exceptions: Accessibility If the substance or mixture is not accessible to the child in foreseeable use then the CMR requirement does not apply. Care must be taken to ensure that the substance or mixture is not restricted in other regulations, standards or directives. Amount present If the substance or mixture is present in concentrations below the classification limits in Directive 1999/45/EC (until 31 May 2015) or Regulation (EC) No 1272/2008 (from 1 June 2015). Appendix A Appendix A contains a list of CMR substances that have been evaluated as being safe for use in toys and the general requirement does not apply. Appendix C Appendix C sets lower limits for concentrations of substances that those listed in Directive 1999/45/EC or Regulation (EC) No 1272/2008 for toys intended for children under three years or to be placed in the mouth. This guide is intended to show Manufacturers how to assess their products for the presence of CMRs as required by the Toy Safety Directive.
Important: The information is this document is for guidance only. If substances are identified at concentrations below the limits specified then this only satisfies the compliance aspects of CMRs related to classification. The Toy Safety Directive also requires the chemical safety aspects to be taken into consideration and it is the manufacturers responsibility to ensure that the presence of CMRS below the concentration limit does not adversely affect children s health. For many substances classified as CMR other limits or restrictions may apply at concentrations below those in CLP. These limits or restrictions may be in particular standards or in REACH Annex XVII. 3. Overview This guide outlines two basic approaches that can be used either individually or together to assess materials in products for the presence of CMR s. These approaches are: Materials approach using the Toyograph If a full bill of substances is not available then a simplified approach based on the information in Toyograph or similar tool kit can be used. Toyograph is an on line resource designed to allow Manufacturers to use the Bill of Materials to determine which materials are at risk of containing restricted chemicals above the limits specified in legislation or at levels that may be a safety concern. CAS number approach If a full bill of substances is available with a complete CAS number listing with weights or concentrations then this approach can be used. In many cases, a combination of the two approaches may be appropriate. Where companies have any doubt about their ability to assess their products for compliance to the CMR requirements, third party expert help may be needed. Separate BTHA Guidance is available with regards to Safety Assessments and How to Use the Toyograph. 4. Definitions CMR: A substance or mixture classified under Regulation (EC) No 1272 as carcinogenic, mutagenic or reprotoxic. Substance: A pure chemical compound or chemical element such as a pigment or polymer additive. Mixture: One or more substances that are present in combination but without any chemical reaction taking place. Most toy materials fall into this category such as plastics that contain the base polymer, a pigment and any number of additives. Carcinogen: A substance or a mixture of substances that induce cancer or increase its incidence.
Mutagen: A substance or a mixture of substances that can cause permanent mutations in human cells that can be transmitted to future generations. Reprotoxin: A substance or mixture of substances that can cause adverse effects on sexual function or fertility, or adversely affect the development of children in the womb, after birth or up to sexual maturity. Classification: CMRs are classified as Category 1A, 1B or 2 depending on the strength of evidence that the substance causes the adverse effect in humans. For example a substance classified as a Category 2 carcinogen is only suspected of causing cancer in humans. CAS Number CAS Registry Numbers are unique numerical identifiers assigned by the Chemical Abstracts Service to every chemical described in the open scientific literature
5. The two approaches Materials Approach using the Toyograph In the Toyograph, each of the available materials has been assessed for the presence of priority substances including substances of very high concern (SVHC). The majority of SVHC are also classified as CMRs. Other substances that are not SVHC but may be likely to be found in a particular material and have a CMR classification are also listed in priority substances on the material report. Appendix A and Appendix C will be added to the material sheets once particular substances have been included and published in the Official Journal.
Is the material accessible? CMRs are restricted by the Directive in accessible materials. N.B this guide deals with the TSD restrictions and other CMR limits from other legislation may also apply. Is a Material Sheet Available? If a material sheet is not available, Manufacturers must obtain further information about the material and use the CAS number approach. (The current scope of the Toyograph can be found on the Toyograph website. Priority Substances? If priority substances are not listed there is a low probability that the material contains CMRs. It s important to note that the Material Reports consider only generic and typical material usage (see below). Other Substances present? The material sheets do not cover specialist additives or particular pigments. Any specialist additives should be assessed using the CAS Number approach. Listed in Appendix A? Certain substances are exempted under Appendix A in the Toy Safety Directive in certain conditions. Check presence and concentration There is a range of concentration limits that can be applied to specific substances but this approach assumes a maximum concentration of 0.1% for each substance based on SVHC criteria. This allows a margin of safety even if the bill of materials or bill of substances does not have sufficient detail to calculate the individual concentration. Manufacturers need to determine the concentration of the substance in the material to ascertain if the material is in compliance. Appendix C of the Directive sets lower limits for concentrations of substances that those listed in Directive 1999/45/EC or Regulation (EC) No 1272/2008 for toys intended for children under three years or to be placed in the mouth.
CAS number approach This approach is the most accurate and reliable method for determining the CMR content in toy materials. It requires an accurate and full bill of substances with individual CAS numbers and individual concentrations of the substance in the material and/or toy. If this route is followed care must be taken to ensure that all substances are listed for each component and material in the Bill of Materials. If this is not the case further information should be obtained from the vendor. The approach can be used however to check particular CAS numbers where available and particularly if a Toyograph materials sheet is not available.
Is the material accessible? CMRs are restricted by the Directive in accessible materials. Identify CAS Number Each substance/material listed on a comprehensive BOM will have a CAS number. CMR? Sources of information are available to identify CMRs: Chemtrac Available to BTHA full members only European Chemical Substances Information System (http://esis.jrc.ec.europa.eu) This is the main source of information for identifying the specific concentration limits that must be applied. Guidance on using the European Chemical Substances Information can be found in Annex I of this document. Toy Safety Directive Appendixes A and C (this information will also be available in Chemtrac) Identify Applicable Concentration limit CMRs will have specific concentration limits listed in Annex VI of Regulation (EC) 1272/2008 or if no limits are shown in Annex VI then the generic concentration limits as per the following table are applied. The generic concentration limits can be found in Annex I of Regulation (EC) 1272/2008 Classification Category Default Concentration Table in Annex I Carcinogenic 1a/1b 0.1% 3.6.2 Carcinogenic 2 1% 3.6.2 Mutagenic 1a/1b 0.1% 3.5.2 Mutagenic 2 1% 3.5.2 Reprotoxic 1a/1b 0.3% 3.7.2 Reprotoxic 2 3% 3.7.2 Concentrations below limits incl. Appendix C? Manufacturers need to determine the concentration of the substance in the material to ascertain if the material is in compliance. Appendix C of the Directive sets lower limits for concentrations of substances that those listed in Directive 1999/45/EC or Regulation (EC) No 1272/2008 for toys intended for children under three years or to be placed in the mouth.
Annex 1 How to use the European Chemical Substances Information System Access the ESIS website: (http://esis.jrc.ec.europa.eu) 1. Select CLP/GHS tab 2. From the dropdown select Search Annex VI Boric acid CAS No 10043-35- 3, which is a flame retardant found in paper and textiles, is used as an example of a substance that has a specific concentration limit. 3. Enter the CAS No and click on Search
4. From the search results screen, click on the index number to reveal the data 5. Identify the CMR classification 6. Check if a specific concentration limit is shown for that classification If no specific concentration limit is shown as in the example below (diisopentylphthalate CAS No 605-50- 5), refer to Annex 1 in this guide for the default concentration limits.