2009/48/EC Chemical safety assessment

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1 2009/48/EC Chemical safety assessment Christian Wetterberg Director External Relations, LEGO Group TIE Webinar 23 May 2013

2 Toy Industries of Europe (TIE) More than 80% of all decisions on socio-economic issues in the 27 EU Member States originate in Brussels. TIE is a partner for dialogue with European and international policymakers and other stakeholders: European Commission European Parliament European Council Standardisation bodies. TIE ensures the industry s interests are represented. TIE wants only safe toys on the market and spends a lot of time educating the industry and other audiences about the new Directive.

3 TIE Members Corporate Members - Bandai - Disney - Ferrero - Hasbro - Hill Toys - Hornby - Lego - Mattel - Schleich - Spin Master National Toy Trade Associations - AEFJ - Spain - Assogiocattoli - Italy - BTHA - UK - Bulgaria - DVSI - Germany - FJP - France - Leksaksbranschen - Sweden - Nordic Association - ORNES - Netherlands

4 TSD implementation phases 18 December July July July 2013

5 Safety assessment in 2009/48/EC (since 20 July 2011) The requirement The requirement is found in 2009/48/EC, article 18: Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical & mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present, as well as an assessment of the potential exposure to such hazards. The aim of a safety assessment is to identify and minimize risks. Can be done at any point before the toy is placed on the market.

6 Safety assessment in 2009/48/EC Three parts of the Safety assessment Mechanical & physical, flammability and electrical hazards for which harmonized standards exist Hygiene and radioactivity hazards for which currently there are no harmonized standards available and the safety assessment is used instead Chemical hazards for which some standards exist and where the mandatory safety assessment is considered to be an alternative to EC Type examination for chemical hazards that are not covered by harmonized standards The European Commission has published a guidance document:

7 Safety assessment in 2009/48/EC Information and skills needed Knowledge about the toy (how is it used, by whom, which materials are used, which substances are used) Knowledge of applicable standards (including the assessments required by the standards) Knowledge of applicable restrictions imposed on certain substances and the scope of these restrictions Knowledge about emerging issues Knowledge about hazards and ability to identify exposure and assess risks

8 Chemical hazards (Some standards available) Chemical hazards regard adverse effects on human health due to exposure, during foreseeable use, to the chemical substances or mixtures of which the toys are composed or which they contain. Note 1: Safety Assessment is considered as an alternative to EC Type examination for chemical hazards that are not covered by harmonized standards Note 2: Particular requirements for these hazards are found in TSD, Annex II Part III

9 Available standards EN 71-3:2013 Migration of certain elements (June 2013) EN 71-4:2013 Chemical experimental sets (February 2013) EN 71-5:2013 Chemical toys other than chemical sets (June 2013) EN 71-7:201X Fingerpaints (late in 2013) EN 71-12:2013 N-Nitrosamines/Nitrosatable substances (June 2013) EN 71-13:201X Olfactory board games, cosmetic kits etc (late in 2013) EN 71-9:2005 Organic chemical compounds (not referenced in the OJEU does not give presumption of conformity) Note: The assessment can reduce and/or target testing. Testing can focus on substances that can reasonably be expected to appear in the toy materials.

10 Scope of the chemical safety assessment A major part is the assessment of the likelihood of the presence in the toy of prohibited or restricted substances It should, however, also cover other chemical hazards (and exposure to these) presented by substances presently not prohibited/restricted but commonly known as undesirable in toys because of their inherent hazards A chemical safety assessment shall therefore consider all applicable regulations and directives and additional relevant information on other substances that children may be exposed to when playing with a toy Note: Other relevant legislations are e.g. REACH (Regulation 1907/2006) and for electronic toys RoHS (Dir. 2002/95/EC)

11 What are ideal conditions for safety chemical assessment? The bill of materials (BOM) includes only approved materials that are traceable (trade names are known) A bill of substance (BOS) is available for all materials All substances in the BOS have been evaluated and found not to exceed concentration and/or migration limits in applicable legislation/standards, and not to present a risk (considering the hazard and the exposure) No changes are made to the BOM or BOS unless the new material/substance has been assessed and approved SDSs are available for all chemicals used in the production (when required by REACH)

12 What are poor conditions for safety chemical assessment? The materials in the BOM are not traceable (i.e., it is not possible to ensure that they are the same from time to time) Materials are sourced only based on price (i.e. there are no long-standing relationships with trustworthy suppliers) The BOS is not known for any materials No SDSs are available for the chemicals used Suppliers/manufacturers are not aware of applicable limit values in regulations/standards Changes are frequently made to the product Test reports do not clearly link results to individual items

13 No exact truth for the chemical safety assessment It is a company decision how to best minimize chemical risk. Every company is different and different models can be used The more control a manufacturer has, the less dependent he will be on others (through declarations/statements etc) The chemical safety assessment is required so as to ensure that a manufacturer carefully considers the chemical hazards that the toy, its materials and contained substances might present to the health of the child Update after changes in product, standards, legislation or new knowledge There may be no truth but good and bad approaches. The closer one can get to the ideal situation the better

14 The approach in the COM- Guidance document 1. Identification Identify substances and materials 2. Characterisation Determine if they are: In scope of legal restriction In scope of standards Suspected/undesired 3. Assessment Likelihood of a material containing more than permitted amounts of a restricted substance or amounts of non-restricted substances that would mean risk (hazard/exposure) Prohibited/restricted Not prohibited/restricted

15 Identification stage Identify substances and materials BOM needed and BOS desirable In case only limited information is available: Worst case assumptions/ where used data (use experience about which materials have been known to contain certain substances) Safety assessment carried out by supplier Request specified declarations/test reports from the supplier Perform selected tests

16 Alternatives to full Bill of Substances Request information from the suppliers such as: Inks, coatings, lubricants and glues Normally possible to get SDS since solvents are used Plastics and paper Plastics: Food contact material-certificates For paper: Certificate regarding lead and optical agents Metals Test certificates for EN 71-3 and Nickel release. Supplier certificate for CMRs Textiles Test certificates for Azo-dyes Ökotex-certification and certificate for formaldehyde and Nonylphenol Add REACH and when applicable RoHS

17 Characterization stage: Relevant questions In scope of legal restriction? Classified as CMR (Annex VI of CLP 1272/2008)? Banned fragrance? Subject to REACH (may depend on how article is used mouthable, prolonged skin contact )? Subject to other applicable legislation (RoHS, national)? In scope of standards? EN 71-3 & EN 71-9 (possibly 71-4, 71-5, 71-7, and 71-13) Suspected/undesired substance? Under discussion for restriction in e.g. REACH or TSD?

18 Assessment stage Based on the identification and characterization - Assess the likelihood of a material containing: more than permitted amounts of a restricted substance, or amounts of non-restricted substances that could present a risk (considering hazard and exposure) The assessment can to various degrees be based on declarations from suppliers, test data, assumptions and evaluation of Bill of substances Chemical Safety assessment = The more data the better

19 Thank you!