Toyograph

Toyograph® has been developed by the BTHA in association with Bureau Veritas as a ‘Chemicals toolkit’ exclusively for full BTHA members.

It has been designed to help identify the restricted substances that are likely to be present within commonly used toy materials so members can decide on appropriate, targeted compliance routes.

Toyograph® is an interactive web based tool designed to allow manufacturers to use their Bill of Materials to determine which materials are at risk of containing restricted substances above the limits specified in legislation or at levels that may be a safety concern.

The Toyograph can be used to:
• Demonstrate compliance to standards and regulations as part of the Conformity Assessment
• Assist in the obligation to ensure Conformity of Series Production with regards to chemical compliance
• Assist in carrying out the Chemical Safety Assessment as required by the Toy Safety Directive
• Assist in the consideration of chemical safety and compliance during product development and product specification
• Identify questions for factories concerning raw material content

The Toyograph is intended to cover commonly used materials and a defined legislative scope.

The chemical requirements of the Toy Safety Directive, which came into force on 20th July 2013, has increased financial pressure on companies when demonstrating compliance and the Toyograph® mitigates those costs by helping establish a risk assessment approach. This type of approach helps give members the option to target testing to higher risk areas rather than simply increasing testing spend.

The materials information in Toyograph has been compiled from a range of sources. Using the base material as a starting point, substances of concern were identified by reviewing a wide range of test data held by the toy industry and by using experience and knowledge of the type of chemicals that are usually found in specific materials. Additional information for each material was added from manufacturers’ data sheets, information held by the European Chemicals Agency and published scientific research. The substances most likely to be present were then cross-referenced with the requirements of the Toy Safety Directive, REACH and the RoHS Directive to identify a priority list of chemicals to give an indication of the safety or compliance issues related to the use of that material in toys. The supporting data and conclusions for each material were then validated by Bureau Veritas Consumer Product Services based on their extensive testing database and expert opinion to ensure the information in Toyograph is as accurate as reasonably possible. A review process is a key element in maintaining this accuracy and the material sheets will be regularly updated with changes in legislation and new information as it becomes available.

By using a bill of materials through Toyograph® full BTHA members and select Bureau Veritas clients can more easily identify which materials are at higher risk of containing restricted substances above the limits set out in legislation or at levels that may be a safety concern and once identified can target testing to ensure compliance. This new risk-based approach means that toy manufacturers are now able to focus their resources on those chemicals and substances that may actually cause concern and by doing so keep control of both testing costs and compliance concerns.

Access Toyograph website here

REACH

REACHReady is available to assist BTHA members with REACH, CLP and BPR needs at a 25% discount off a REACHReady Gold Membership. For more information and to subscribe email to enquiries@reachready.co.uk

It came into force on 1^st June 2007 and the central aim of the legislation is to reduce risks to human health and the environment from the use of chemicals. The Directive intends to make companies that place articles, substances and mixtures on the market (the importer) responsible for understanding and managing the chemical risks associated with their use. It also ensures that companies are aware of the substance content of chemical mixtures and articles.

The BTHA has produced guidance on REACH for Toy Manufactures in the following areas considered to concern toy companies.

BTHA Overall Guide

Which covers the following areas:

• Operator Roles
• Reach Definitions
• Safety Data Sheets
• Registration of substances
• Annex XIV
• Annex VII
• Substances of Very High Concern

BTHA Overall Guide
In addition to this guide the BTHA has produced more detailed guidance as follows:

Imminent Restriction on Microplastics under the EU REACH Regulation
After many delays, Member States have voted in favour of the EU Commission’s proposal for a restriction for microplastics in REACH Annex XVII. The draft regulation is now subject to scrutiny by the European Parliament and Council. It is likely that the regulation will be published in the Official Journal of the European Union in the second half of September and will enter into force 20 days later.

For toys, the regulation will apply without a transition period to products newly placed on the market. Products that are already on the market will not be affected.

Restriction on Microplastics under EU REACH Regulation

Microplastics
Annex XVII of REACH has been amended by regulation 2023/2055 to restrict the placing on the market of microplastics on their own and in mixtures.  The requirements apply from 17^th October 2023.  Later in-force dates apply for cosmetic products and encapsulated fragrances.

Microplastics

SCIP database
There is an existing obligation to communicate the presence of SVHCs in articles along the supply chain and to consumers upon request. The recent amendment to the Waste Framework Directive (EU) 2018/851 (WFD) generated an additional requirement to upload the presence of SVHCs in products above 0.1% to the ECHA SCIP database. The BTHA has produced a short guide outlining obligations for this companies supplying goods into the EU from 5th January 2021. Since this implementation date is after the UK has left the EU, this guidance explains the impact on UK based companies and the effect of Brexit on their obligation to submit SCIP notifications.

SCIP Guide after BREXIT

REACH SVHCs
This subject is covered in the main guide and in addition the BTHA has published a full searchable Excel Spreadsheet detailing all the SVHC’s on the website which can be used in conjunction with this guide. The Spreadsheet includes a summary of the SVHC’s which are considered to be at a High, Medium or Low risk of being found in toys.  The Spreadsheet will show how many SVHC’s have been analysed at the date of use. It is checked and if necessary updated three times each year.

Each SVHC has been categorised by its likely risk for inclusion in an article above the 0.1% limit.

REACH SVHC's

REACH ANNEX XVII
This REACH ANNEX XVII guide is intended to help with the substance restrictions under Annex XVII of REACH only.

Please note that Annex XVII of REACH has been amended by regulation 2023/2055 to restrict the placing on the market of microplastics on their own and in mixtures.  For more information see the Microplastics section above

It is important to note that this guide only covers the Annex XVII substances that are considered to be at risk of being found in typical toys.  However, the use of unusual materials or applications may mean unexpected substances could be found. Users should always refer back to the original legislation and may need to take expert third party advice.

In writing this guide, all entries in Annex XVII have been assessed. Certain entries are not relevant to toy products and are not covered by this guide. These include those that are not ever used or found in typical toys, those restricted in materials or products not used in toy products (e.g. paint strippers), and those entries that specifically exclude toys. For this reason, it is not recommended that this guide is used for non-toy products.

REACH Annex XVII

Classification, Labelling & Packaging

The CLP Regulation adopts the United Nations’ Globally Harmonised System on the classification and labelling of chemicals across all European Union countries.

The CLP Regulation entered into force on 20 January 2009. The objective of the CLP Regulation is to identify the intrinsic hazards of a chemical substance or mixture in a standardised way and to ensure that these are communicated throughout the supply chain.

CLP replaces previous legislation related to the supply of hazardous chemicals such as the Dangerous Substances Directive and the Dangerous Preparations Directive. These two directives were repealed on 1st June 2015.

The Regulation has been introduced in stages:

• Requirement to classify, label and package substances came in to force on 1st December 2010
• Requirement to classify, label and package mixtures came in to force on 1st June 2015

Definitions

There are precise definitions for substances, mixtures and articles, which are taken from REACH as follows: 

Substance(s): A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any identified impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. An example of a substance in a toy would be a container of sodium carbonate supplied in a chemistry set. 

Mixture: A mixture or solution composed of two or more substances. Mixtures are common in toys and good examples would be finger paints, bubble solution and glues. Some toy products may be borderline articles and ECHA provides detailed guidance on how to determine if a product is a mixture or an article. One determination by ECHA considered that wax crayons were mixtures. 

Article: An object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.

Who is affected?

The obligations under CLP depend on the role of the supplier.

The definition of roles in this regulation differs from those in the Toy Safety Directive and it is recommended that you determine your particular role in the supply chain by using the guidance on the CLP regulation published by ECHA.

The toy companies mostly affected by CLP will be those supplying chemical toys including materials for creative play and other liquid toys, although it is advised that the company should determine their own particular obligations by reference to the ECHA guidance.

Obligations

1. Articles

The requirements for articles are limited to those where the substance in an article is present, is intended to be released and the amount of the substance imported exceeds one tonne per year, or the substance meets the criteria of a substance of very high concern present above 0.1% and the amount of the substance imported exceeds one tonne per year.

1. Classification of mixtures and substances

The obligation to classify is based on two pieces of legislation, the CLP regulation itself and the REACH regulation.

If obligated you must classify these substances or mixtures before placing them on the market, regardless of the tonnage manufactured, imported or placed on the market.

1. Ensure safety data sheets are produced in accordance with Article 31 of REACH

Safety data sheets include information about the properties of the substance or mixture, its hazards and instructions for handling, disposal and transport and also first-aid, firefighting and exposure control measures. The format and content of the safety data sheets are specified in REACH. 

1. Labelling

Products need to be labelled if the substance or mixture is classified as hazardous, or if the mixture contains one or more substances classified as hazardous above the concentrations referred to in Part 2 of Annex II to CLP.

There are two EN71 standards for chemical toys. EN71-4: 2013 Experimental sets for chemistry and related activities and EN71-5: 2015 Chemical toys (sets) other than experimental sets. Both of these standards incorporate the labelling requirements of CLP.

It is important to note that while CLP allows a relaxation on the labelling elements for small packages, the toy standards require that all information must be on the package without limitation. Some chemical toys may not be within the scope of the standards and therefore the small packaging exemptions may be applied.

The labelling should include the following elements as appropriate:

• Name, address and telephone number of the supplier of the substance or mixture (already an obligation under TSD)
• Nominal quantity of the substance of mixture
• Product identifier (for mixtures the identity of all substances in the mixture that contribute to the classification of the mixture as hazardous)
• Hazard pictogram(s)
• Signal word(s)
• Hazard statement(s)
• Precautionary statement(s)

Labelling should be provided in the languages of the countries where the product is placed on the market. 

1. Notification

Notification is required if you are an importer and the substance is:

• Subject to registration under REACH (> 1 tonne/year) and placed on the market;
• Classified as hazardous under CLP and is placed on the market, irrespective of the tonnage;
• Classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I of CLP, which results in the classification of the mixture as hazardous, and the mixture is placed on the market.
• Retain records for 10 years after the substance of mixture was supplied.

Further information

CLP is a complex regulation and BTHA members are advised to refer to the original legal text or the official ECHA guidance if they think they may be affected. The ECHA guidance documents provide comprehensive interpretation of the regulation and can be found on the ECHA website: www.echa.europa.eu/regulations/clp

The regulation also provides for member states competent authorities to operate national help desks.

The competent authority in the UK is the Health and Safety Executive:

REACH and CLP UK CA Help Desk, Health and Safety Executive
2.3 Redgrave Court, Merton Road, L20 7HS Bootle, Merseyside
Email: ukreachca@hse.gsi.gov.uk

Chemicals Update

Brief details of the restrictions are given but full details should always be sought from the text of the actual legislation. In some cases BTHA Specific Substance Guides may be drafted for certain substances to give more details.

Chemicals Update List - October 2023

BTHA Technical Committee Presentation on Chemicals Update - May 2022

Individual Substance Guides

The guidance in the documents is based on research of generic materials and the likelihood of a substance being used or present in those materials and therefore provides a reasonable indication of the compliance risk. Specific additives or innovative uses of materials may affect the compliance of the material and what may be present within it.

Aniline

Nonylphenol Ethoxylates

Formaldehyde

Titanium Dioxide

Organostanic Compounds

PAH Guide

Bisphenol A (BPA)

Formamide

SCCP

TCEP, TCPP and TDCP

Phenol

CMI: MI (Kathon), CMI, MI, BIT

Benzene

Cadmium

Phthalates Entry 51 V3

Phthalates Entry 52 V2

CMRs in Textiles Specific Substance Guide

CMR Guides

The Toy Safety Directive (2009/48/EC) and the Toys (Safety) Regulations (2011 No 1881) requires that toys and components of toys shall not contain substances that have a harmonised classification of CMR – Carcinogenic, Mutagenic, or toxic.  The guide below for CMR’s has been produced for members which outlines three basic approaches that can be used either individually or together to assess materials in products for the presence of CMR’s and so demonstrate compliance.    In addition, the Toy Safety Directive 2009/48/EC Annex II includes requirements related to CMR’s and other chemicals in Appendix A and Appendix C.  This new guide is intended to provide an up to date list of the chemicals listed within these specific sections.

CMR Guide

Appendix A and C Guide