One of the legal obligations for a toy manufacturer (including an own-brand importer) under the Toy Safety Directive 2009/48/EC (TSD) is to carry out, amongst others, a Chemical Safety Assessment (CSA) on the chemical hazards that the toy may present (Article 18). This evaluation and assessment is an integral part of the technical documentation and must be performed prior to placing the toy on the market. This requirement has been in force since July 2011.
Under the TSD, a manufacturer has legal obligations to perform a CSA on the toy product to comply with the Technical Documentation (TD) requirements. An importer of toys has a duty to ensure that the manufacturer performs the elements required for the TD. The TD must be kept for 10 years after the toy has been placed on the market and must be made available within 30 days upon request to market surveillance authorities for inspection. Failure to do so may result in the toy being required to undergo testing within a specified period by the notified body at the manufacturer’s expense.
In the context of the TSD, toys are also obliged to comply with applicable EUlegislation on chemicals such as REACH (restricted substances under ANNEX XVII and substances of very high concern (SVHCs)) as well as the Classification, Labelling and Packaging of Certain Substances and Mixtures; the CLP Regulation (EC) 1272/2008.
In the framework of the CSA, a manufacturer may assess the likelihood on the presence of restricted, prohibited or undesirable substances in a toy material.
The CSA is a complex process and essentially has three major stages. These are summarised in Table 1.
Table 1. CSA Stages
To study the toy and to identify the accessibility of materials in the toy.
To identify substances and materials and their concentrations from documents such as bill of materials (BOM), bill of substances (BOS) and Safety Data Sheets (SDSs).
Each substance and material identified in stage 1 is reviewed against scope, restriction and prohibition e.g.:
Classification of chemicals under CLP.
Chemicals restricted or prohibited under TSD e.g.:
· CMRs (carcinogenic, mutagenic or reprotoxic substances).
· Nitrosamines and nitrosable substances.
Chemicals restricted under REACH e.g.:
· Restricted substances under ANNEX XVII.
· SVHCs on Candidate List.
To establish the likelihood of a restricted, prohibited or an undesirable substance in a toy material.
To assess exposure by consideration of:
· Intended age of user.
· Intended and foreseeable use.
· Exposure routes (e.g. dermal, oral or inhalation).
The result of the CSA should be a statement regarding the safety of the toy in relation to the safety assessment requirements under Article 18 of the TSD. Testing can be based on the assessment and considerations can be given to substances that can reasonably be expected to appear in the toy.
When does the CSA need to be updated?
A CSA may need to be updated due to: Changes to chemicals used in manufacturing. Availability of new toxicological data for chemicals. Changes in legal requirements. Consumer complaints or product withdrawal from market.
Throughout our global network of laboratories, we have an international team of professional experts equipped with a comprehensive knowledge on chemicals and restricted substances in toy safety for compliance with the chemical safety assessment provisions under the Toy Safety Directive.
For further details, please contact your local sales representative or the global team:
Hing Wo Tsang
Senior Technical Services Manager
SGS Hong Kong Ltd.
t: +852 2774 7420
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.