producttesting
Testing for chemical compliance Dr Derek Hepburn, managing director of Eurofins product testing, reports on the
recent changes to the legislation on chemical compliance in toys
of the European Union and entered into force on 20 July 2009. The 2009 TSD is written to align with the current
T
practices of toy manufacturers, and strengthens the rules as laid down in earlier European Directives. As a result, the TSD has required adaptations in the manufacturing chain, as well as new procedures along the supply chain. The general provisions of the TSD are applicable
to toys placed on the market since 20th July 2011, while the chemical provisions will be applicable to toys placed on the market as of 20th July 2013 (additional two-year transition period for chemical properties). It is important to note that the TSD does not affect the requirement that all items must comply with the existing General Product Safety Directive (2001/95/EC), which defines a safe product as one that “presents minimal or no risk when used in a foreseeable way”.
The TSD and its supporting standards The new EN 71-1 standard on mechanical and physical properties of toys was published in June 2011 (EN71-1 is one of the main toy safety standards as it contains requirements for the design, strength, performance and labeling of toys). EN71-2 standard on flammability of toys was published in September 2011. EN71-3 on the migration of certain elements
from toys is expected to be submitted for formal vote in February 2013 and is likely to come into force from July 2013. EN 71-4 Chemical experimental sets is expected to be submitted for formal vote in April 2013 and is likely to come into force from September 2013. EN 71-5 Chemical toys other than sets is expected to be submitted for formal vote in March 2013 and is likely to come into force from October 2013.
EN 71-7 Finger paints is expected to be submitted for formal vote in May 2013 and is likely to come into force from September 2013. EN71-8 was harmonised in October 2011. EN71-12 for nitrosamines and nitrosatable substances is expected to be submitted for formal vote in April 2013 and is likely to come into force from September 2013. EN71-13 for Olfactory board games, cosmetic kits and gustative games is expected to be submitted for formal vote in April 2013 and is
64 Toyworld
he toy safety directive 2009/48/ ec (TSD) has placed new responsibilities on manufacturers, importers and retailers of toys for sale in Europe. The TSD was published in the Official Journal
likely to come into force from September 2013. EN 62115 standard on electric toys was published August 2011. Although the chemical requirements of the new directive do not start to enter into force until July 2013, the manufacturer is obliged to carry out a chemical safety assessment from 20th July 2011. It is necessary to understand that the general chemical safety requirement in the current directive (88/378/EEC) already specifies that toys are not permitted to contain hazardous substances in amounts that may harm the health of children. It can already be considered unacceptable to use carcinogenic, mutagenic or toxic to reproduction (CMR) substances in toys (at certain concentration levels), even if the specific ban on CMRs in the new directive only takes effect from 20th July 2013. A good chemical safety assessment requires knowledge about the toy, how it is used, the materials used, the substances used, and the restrictions imposed on certain substances, their scope, and the substances that are under discussion as undesirable in toys. In order to stay updated on the substances under discussion, membership of a trade association is recommended.
Carrying out a chemical safety assessment A chemical safety assessment should focus on assessing the likelihood that a toy contains substances that are banned or whose use is subject to restrictions in standards and directives, but it should also include an assessment of other potentially undesirable substances. Examples of substances that should be handled in the safety assessment are those that are classified as CMR, fragrances, substances regulated under directives and regulations other than the TSD (e.g. Annex XVII of REACH (Registration, Evaluation, Authorisation and restriction of CHemicals), and substances that are suspected of being undesirable but have not yet been banned or restricted in toys (e.g. substances on the so called SVHC-list). It is invaluable to have access to the Bill of
Materials (BOM) and a Bill of Substances (BOS), preferably with the CAS or EINECS numbers of substances/mixtures and safety data sheets (SDS). Manufacturers of the chemical substance/ mixtures are obliged to supply SDSs. If you do not have such information or only have limited information, you can still carry out the safety assessment, but this typically includes more dialogue with the producer, making worst-case assumptions and more chemical testing than is specified in the chemical standards. It is valuable
to have reliable suppliers who are prepared to provide the detailed information you need. A model for carrying out a chemical safety assessment is to divide it into three stages: identification, characterisation, and evaluation. Identification involves studying the toy and its documentation to identify materials and substances used, and preferably the quantities or concentrations of these substances. Knowledge of where these substances are present in the toy is also useful, for example if the substances are inaccessible, are accessible in parts that can be placed in the mouth, or are available in parts that can be in prolonged skin contact. The characterisation step includes checking the identified substances against known prohibitions/ restrictions, and scientific knowledge and/ or discussions about potentially hazardous substances. To determine whether a substance is subject
to a prohibition/restriction, it is necessary to know if and how the substance is classified, e.g. if a substance is classified as a CMR. This classification is available in Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). On the internet, you can search for the CLP-classification using the CAS or EINECS number of the substances/ preparations. The characterisation intends to attribute the
material/substance to one of two groups: • Materials/substances that are restricted in the standards or legislation/regulations
• Materials/substances that are not subject to restrictions
The evaluation step involves determining
the probability that a given material contains undesirable substances in quantities or concentrations that are high enough to cause an unacceptable risk taking into account the hazard and the user’s exposure to it. In the case of materials/substances subject to restrictions/bans, you need to assess the
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108