Lego safety ppt


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Lego safety ppt

  1. 1. Safety Assessment according to Directive 2009/48/EC Christian Wetterberg Director Governmental Affairs LEGO Group
  2. 2. Safety assessment in 2009/48/EC Speaker presentation Christian Wetterberg Director Governmental Affairs, LEGO •Convenor of the working group responsible for EN 71-1 in the European Committee for Standardization (CEN) •Chairman of the technical committee for toy safety in the International Organization for Standardization (ISO) •Participant in the toy expert sub-group that elaborated guidelines for the technical documentation under the new Toy Safety Directive (TSD)
  3. 3. Safety assessment in 2009/48/EC 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 requirement is in place since 20 July, 2011 also for chemical hazards although the new chemical requirements do not come into force 20 July, 2013
  4. 4. Safety assessment in 2009/48/EC The aim The aim of a safety assessment is to identify and minimize risks before the toy is placed on the market • The safety assessment is defined as: “An analysis of the hazards that the toy may present and an assessment of the potential exposure to such hazards.” • A risk is defined as: “The probable rate of occurrence of a hazard causing harm and the degree of severity of the harm. “ • The safety assessment is thus a form of risk assessment.
  5. 5. Safety assessment in 2009/48/EC The three parts The safety assessment can be divided in three parts: •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
  6. 6. Safety assessment in 2009/48/EC When is it performed? At what stage should the safety assessment be performed? • The assessment can be carried out at any stage of the development process • For many companies the safety assessment is an integrated part of the product development process • There will be more options open to assess and manage hazards if they are identified at an early stage • Regardless of when it is carried out, the safety assessment must relate to the toy that will finally be placed on the market • Do not confuse with risk assessments carried out under RAPEX for products already placed on the market
  7. 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 standard) • 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 hazards • Ability to evaluate risk Note: It is permitted to use third party services for the safety assessment (not NB). However, the manufacturer is always responsible for its content
  8. 8. Mechanical, physical, flammability, electrical Mechanical and physical, flammability and electrical hazards (harmonized standards exist) The toy: •Identify users and intended and foreseeable use •Identify hazards The standards •Identify applicable standards (EN 71-1, EN 71-2, EN 71-8, EN 62115) •Determine if they cover all hazards Decision OK? Redesign? EC type examination? Note: Particular requirements for these hazards are found in TSD, Annex II - Parts I, II and IV
  9. 9. Mechanical, physical, flammability, electrical The process Identify toy Describe use Identify hazards Identify applicable harmonised, referenced standards NO Are all hazards covered by the harmonised and referenced standards? YES Are any applicable notices published in OJEU list of standards? Risk management or EC type examination NO YES OK to place the toy on the market
  10. 10. Mechanical, physical, flammability, electrical Identifying hazards Ways of identifying hazards Use sources of reference: Experience, consumer complaints, weekly RAPEX list, CPSC recalls, other standards (ISO and ASTM), newsletters, trade associations, European Commission’s guidance document, etc. Consider the unexpected: Unusual play patterns, unusual play environments, innovative materials, etc. Standards are written for today’s products Be extra careful when designing innovative products
  11. 11. Mechanical, physical, flammability, electrical Managing residual risks • A toy that presents a hazard not covered by harmonized, referenced standards, should be submitted to EC type examination or its design should be changed • The manufacturer may find that a hazard is covered by the standard but wishes to go further, e.g. by applying other standards, adding warnings or giving advice to consumers • In some cases the standards themselves require that a “mini” risk assessment is made when checking compliance with specific requirements
  12. 12. Mechanical, physical, flammability, electrical Examples of assessment required by a standard ”Mini” risk assessments required by EN 71-1: • Determine if toy material is visually clean and free from infestation • Assess if toys that fail the test for sharp edges or sharp points present an unreasonable risk of injury • Assess if tubes and rigid components in the form of projections constitute a puncture hazard (only then do they need to be protected) • Assess if a driving mechanism has sufficient power to injure fingers or other parts of the body (otherwise it is not covered by certain requirements)
  13. 13. Mechanical, physical, flammability, electrical The LEGO Group approach as an example • LEGO® produces a building system: A new, approved element shall be possible to use in all building sets for the same intended age group • For each new element an ”Element risk assessment” is performed at the design stage, based on internal product safety requirements • For each new model a ”Model review” (incl. a ”Model risk assessment”) is performed in addition • At start of production a ”Toy safety report” is elaborated based on tests to internal requirements • Thereafter implementation of internal production control • Finished goods testing should bring no surprises
  14. 14. Mechanical, physical, flammability, electrical Example of LEGO “Element risk assessment”
  15. 15. Mechanical, physical, flammability, electrical The LEGO Groups internal requirements - examples • DUPLO® (for children all age groups) : Internal design cup used – a 36,4 mm small parts cylinder (normal is 31,4 mm) for all elements • All elements used near the mouth (e.g. resembling humans, animals or food) shall comply with internal 1,5” template (approx 38 mm) LEGO Design cup LEGO 1,5” template
  16. 16. Mechanical, physical, flammability, electrical The LEGO Groups internal requirements – examples (cont.) • The flame is moulded in soft material and with an initiated bend to ensure it does not constitute a hazardous projection • An umbrella is supplied with a ”collar” with a 10 mm diameter ending 17 mm from the end of the stick to avoid potential puncturing of ear drum
  17. 17. Hygiene and radioactivity Hygiene and radioactivity hazards (no harmonized standards available) Hazards related to hygiene can be either related to: • The risk of microbiological contamination of toys that contain liquids or natural materials such as nuts, pips, etc. • The possibility to clean and/or wash the toy (for < 3 years) • Hazards related to radioactivity are so far unheard of in toys but need to be considered Note: There is no explicit expectation that toys will be submitted to EC Type examination to verify that there are no hygiene or radioactivity hazards Note: Particular requirements for these hazards are found in TSD, Annex II - Parts V and VI
  18. 18. Hygiene and radioactivity Microbiological hazards, infection and sickness: TSD - Requirement Toys must be designed and manufactured in such a way as to meet hygiene and cleanliness requirements in order to avoid any risk of infection, sickness or contamination. Action needed • Toys containing liquid or aqueous based material (paint, modeling clay, etc.) or natural materials (nuts, pips, etc.) should be evaluated for the presence of microbiological contamination. • This requires testing to e.g. a protocol adopted by the notified bodies: “Microbiological safety of toys containing aqueous media”*, or to methods described in the European Pharmacopeia (EP) or in the US Pharmacopeia (USP) *
  19. 19. Hygiene and radioactivity Cleaning/washing requirement in TSD A toy intended for use by children under 36 months must be designed and manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer’s instructions.
  20. 20. Hygiene and radioactivity Cleaning/washing - the process Is the toy intended for children under 3 years? NO Toy not covered by the requirements YES Is it a textile toy? NO Make sure the toy can be cleaned. Add cleaning instructions if appropriate. YES Does it contain a mechanism that can be damaged by soak wash? YES NO Make sure the toy can be soak washed. Add soak washing instructions if appropriate. Make sure the toy can be cleaned. Add cleaning instructions if appropriate.
  21. 21. Hygiene and radioactivity Radioactivity – the requirement and process Radioactivity – particular requirements Toys shall comply with all relevant measures adopted under Chapter III of the Treaty establishing the European Atomic Community. Has radioactive material been added? YES Do not place toy on the market NO OK to place the toy on the market
  22. 22. Chemicals Chemical hazards (some harmonized 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: SA considered as an alternative to EC Type examination for chemical hazards that are not covered by harmonized standards Note: Particular requirements for these hazards are found in TSD, Annex II – Part III
  23. 23. Chemicals Chemical requirements in TSD from 2013 (rough summary!) • Toys shall comply with other relevant EU-legislation • CMR-substances shall not be used in accessible parts of toys in concentrations exceeding CLP-limits - Reg 1278/2008 (derogations for FCM-material and substances in App A) • 55 allergenic fragrances shall not be used over trace levels and for 11 other special marking is required • Cosmetic toys shall comply with cosmetics directive • Migration limits for 19 substances in 3 material categories • Nitrosamines prohibited in “under 3 toys” and toys intended for mouthing – low migration limits apply
  24. 24. Chemicals Available standards (not before 2013) • • • • • EN 71-3 “Migration of certain elements” EN 71-4 “Chemical experimental sets” EN 71-5 “Chemical toys other than chemical sets” EN 71-7 “Fingerpaints” EN 71-X “N-Nitrosamines and Nitrosatable substances” • EN 71-9 “Organic chemical compounds” (not referenced in the OJEU – does not give presumption of conformity) No standards available for CMR-substances or fragrances Note: The assessment can reduce and/or target testing. Testing only needs to be considered for substances that can reasonably be expected to appear in the toy in question.
  25. 25. Chemicals 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. Note: Other relevant legislations are e.g. REACH (Regulation 1907/2006) and RoHS (Dir. 2002/95/EC) for electronic toys)
  26. 26. Chemicals What are the ideal conditions for a successful chemical safety assessment? • The bill of materials (BOM) includes only approved materials that are traceable (tradenames 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 an inherent hazard (if the defined user can be exposed to them) • 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)
  27. 27. Chemicals When does the safety assessment need to be updated • Changes are made to the product (design, raw materials, additives, paints, etc.) that may affect the safety aspects • Changes occur in legal requirements or in standards • New scientific information on a specific substance becomes available • Consumer complaints suggest that the toy presents a risk • Recalls are made of similar toys after a risk assessment If these factors do not change there is no need to renew the safety assessment. Instead – focus on production control
  28. 28. Chemicals What are poor conditions for a successful chemical safety 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
  29. 29. Chemicals 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 There may be no “truth” but good and bad approaches. The closer one can get to the ideal situation the better
  30. 30. Chemicals The approach in the 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 nonrestricted substances that would mean risk (hazard/exposure) Prohibited/restricted Not prohibited/restricted (Classified/Non classified)
  31. 31. Chemicals Identification of substances and materials Identify substances and materials: • BOM needed and BOS desirable (usually available for formulated mixtures and polymers ) • Store (M)SDS - a legal requirement and a great help • Note info on where/how the material is used (for exposure) In case only limited info is available: • Worst case assumptions/”where used” data • Supplier declarations that substances are not used • Safety assessment of substances carried out by supplier • Perform selected tests
  32. 32. Chemicals Identification Needed for a full chemical safety assessment Only relevant for accessible parts Specific for every trade name Will become more and more important in the future Bill of Substances Requires control of raw materials to avoid surprises Needed for a good chemical safety assessment Can be found through the (M)SDS
  33. 33. Chemicals Characterization stage 1. In scope of legal restriction? Use CAS-number to check: • Classified as CMR (Annex VI of CLP 1272/2008)? • Fragrance? • Subject to REACH (may depend on how article is used – mouthable…, prolonged skin contact…) • subject to other applicable legislation (RoHS, national) 2. In scope of standards? • Use BOM/BOS and check EN 71-3 & EN 71-9 (in specific cases also 71-4, 71-5 or 71-7) 3. Suspected/undesired substance? • Classified for health effect other than CMR (Annex VI of CLP): • Self-classification on SDS? • Check databases, follow industry info, check RAPEX etc
  34. 34. Chemicals Assessment Assess the likelihood of a material containing • more than permitted amounts of a restricted substance, or • amounts of non-restricted that would mean risk (considering hazard and exposure) 1.Classified as prohibited/restricted: •Need to know percentage of substance in material •Check if limits are exceeded (total conc. or migration) •If BOM is not present: • “Where used-data” (assume worst-case). If worst-case shows “no go”, then • Testing
  35. 35. Chemicals Assessment (continued) 2. Not classified as prohibited/restricted • Classified for other health effects in CLP • Exposure and hazard will decide the risk. Consider • Age group, Foreseeable use, Exposure routes (ingestion, inhalation, dermal) • Use industry experience (e.g. ABS does not normally show migration of monomers but PVC-plasticizers could migrate). If data is not available assume worstcase (100 % migration) and if worst-case shows “no go” then test to see real migration • Not classified in CLP • Follow advice from industry associations, follow NGOs, individual authorities etc and risk-manage
  36. 36. Chemicals Summary: The LEGO Groups identification/characterization/ assessment (resins, inks, glue, lubricants etc) • Obtain supplier name and substance/mixture trade name and CAS-number, as well as amount or %-age used • Check classification and possible specific concentration limit in CLP (1272/2008 on Classification, Labelling and Packaging) • If substance is CMR, check against limit values • If classified as e.g. acute toxicity, corrosive properties, ability to trigger allergic reactions, evaluate exposure and define risk • Check REACH Annex XVII, RoHS (when applicable), fragrances/nitrosamines and EN 71-9 • Check other databases/lists (SIN-list, Bfr, SVHC, NGO-lists etc) • Run substance through automated toxicological assessment (utilizing “SciVera Lens”)
  37. 37. Chemicals Using the CLP • Find CAS-number (e.g through ESIS European chemical Substances Information System) • Use table 3.1 in ANNEX VI of CLP (1272/2008) vant-legislation/index_en.htm and: • Search for the CAS-number and read classification/specific concentration limit (Carc 1B, Muta 1B, Repr 1 B, SCL 0,01 %)
  38. 38. Chemicals Using the CLP (continued) • If there is no SCL (Specific concentration limit) the general limits apply (until 2015 different limits may apply in DPDdirective 1999/45/EC). Example from CLP:
  39. 39. Chemicals Alternatives to full BOS Inks, coatings, lubricants and glues • Normally possible to get SDS since solvents are used and thus SDSs are elaborated Plastics and paper • Possible to request Food contact material-certificates • For paper: Certificate regarding lead and optical agents Metals • Test certificates for EN 71-3, Nickel release, Total lead. Supplier certificate for CMRs Textiles • Test certificates for Azo-dyes • Request Ökotex-certification and certificate for formaldehyde and Nonylphenole Add REACH and when applicable RoHS
  40. 40. Internal Production Control Internal Production Control • Continuously adapt to type of production and experience • Where and during which phase could a “quality dip” have serious effects (in warehouse, in production, after production, etc) • Statistical sampling depending on experience, total numbers produced, sensitivity of production • Example: Small parts is critical in assembled toys for children under three. Therefore LEGO applies 100 % tension test check on heads of DUPLO-figures and wheels of DUPLO-wagons
  41. 41. Internal Production Control An example from the LEGO Group External Internal Raw material supplier Yearly test Assembly Component supplier Yearly test Batch size test at selected suppliers Part supplier Yearly test Batch size test at selected suppliers Moulding Random visual inspection of assembled elements Visual inspection of set of elements one time per shift. Decoration Periodic visual inspections by operators. Minimum frequency – 1x per hour. Results of periodic in process inspections must be documented. Prepack 1 internal sample per 5000 produced - used for DPMO calculation and reporting. Final Pack 1 internal sample per 2000 produced - used for DPMO calculation and reporting. Yearly chemical test of all play materials in the product.
  42. 42. The end Thank you! Questions?