BTHA Guidance

Chemical Guidance

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

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BTHA Yordas Hive®

Yordas Hive is a powerful, comprehensive, time-saving and cost effective software solution for regulatory compliance. With a database of almost 250,000 substances and more than 600 global regulations, Yordas Hive helps you stay up to date with your obligations.

REACH

REACH is an acronym that stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals.

 

It came into force on 1st 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 guidance in these 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.

REACH SVHCs

The BTHA has produced a guidance document which takes all the current SVHCs (Substances of Very High Concern) and categorises them as high, medium or low risk of being found above 0.1% in a toy material. It is intended to help with the restrictions for  SVHC identified in the “Candidate list” under REACH only.

Members can use this spreadsheet to target work and assessments on products and to discuss the likelihood of the presence of a substance with their customers.

REACH SVHC's

REACH ANNEX XVII

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

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

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Classification, Labelling & Packaging (CLP)

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

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Chemicals Update

The chemicals update sheet gives details of substances where new restrictions are under way or are agreed but which are not yet in force. It enables BTHA members to anticipate and investigate future restrictions so that they can understand the impact and any likely actions which are needed.

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 Sheet

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Individual Substance Guides

The BTHA produces a list of substance guides.  Each substance guide outlines the Regulatory Requirements the most likely sources of the substance(s) in toy materials and gives an indication of the risk of the substance (s) being found in common toy materials above legal limits.  Lastly, it shows any actions you can take with regards to the supply chain to lower the risk of non-compliance.

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.

PAH Guide

Bisphenol A (BPA)

Formamide

SCCP

TCEP, TCPP and TDCP

Phenol

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

Benzene

Cadmium

Phthalates Entry 51 V2

Phthalates Entry 52 V2

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CMR Guide

Compliance Strategies