lego safety ppt

Safety Assessment according to Directive 2009/48/EC

Christian Wetterberg

Director Governmental Affairs

LEGO Group

Safety assessment in 2009/48/EC

Speaker presentation

Christian WetterbergDirector 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)


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


The aim

• 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.

The aim of a safety assessment is to identify and minimize risks before the toy is placed on the market


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


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


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

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

DecisionOK? Redesign? EC type examination?

Note: Particular requirements for these hazards are found in TSD, Annex II - Parts I, II and IV


The process

Identify toy

Describe use

Identify hazards

Identify applicable

harmonised, referenced standards

Are all hazards covered by the

harmonised and referenced

standards?

Risk management or EC

type examination

Are any applicable notices

published in OJEU list of

standards?

OK to place the toy

on the market

NO

YES

YES

NO


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 productsBe extra careful when designing innovative products


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


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)


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

Mechanical, physical, flammability, electricalExa

mp

le o

f LEGO

“Elem

en

t risk asse

ssme

nt”


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


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

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


Microbiological hazards, infection and sickness:

TSD - RequirementToys 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)

* http://ec.europa.eu/enterprise/sectors/toys/files/recommendations/protocol_no_2_microbiological_safety_of_toys_rev_1_en.pdf


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.

Cleaning/washing requirement in TSD


Cleaning/washing - the process

Is it a textile toy?

Toy not covered by the

requirements

Make sure the toy can be

cleaned. Add cleaning

instructions if appropriate.

NO

YES

YES

NO

Is the toy intended for

children under 3 years?

Does it contain a

mechanism that can be

damaged by soak wash?

YES

Make sure the toy can be

cleaned. Add cleaning


Make sure the toy can be soak

washed. Add soak washing


NO


Radioactivity – the requirement and process

Has radioactive

material been added?

OK to place the toy

on the market

Do not place toy on

the market

NO

YES

Radioactivity – particular requirementsToys shall comply with all relevant measures adopted under Chapter III of the Treaty establishing the European Atomic Community.

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

Chemicals

• 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

Chemical requirements in TSD from 2013 (rough summary!)

Chemicals

• 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

Available standards (not before 2013)

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.

Chemicals

• 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.

Scope of the chemical safety assessment

Note: Other relevant legislations are e.g. REACH (Regulation 1907/2006) and RoHS (Dir. 2002/95/EC) for electronic toys)

Chemicals

• 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)

What are the ideal conditions for a successful chemical safety assessment?

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

Chemicals

• 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

What are poor conditions for a successful chemical safety assessment?

Chemicals

• 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

No exact “truth” for the chemical safety assessment

There may be no “truth” but good and bad approaches. The closer one can get to the ideal situation the better

Chemicals

The approach in the guidance document

1. Identification• Identify substances and materials2. 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 (Classified/Non classified)

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

Chemicals

Bill of Substances

Needed for a full

chemical safety

assessment

Needed for a good chemical

safety assessment

Will become

more and more

important in the

future

Only relevant for

accessible parts

Can be found

through the

(M)SDS

Specific for every

trade name

Requires control

of raw materials to

avoid surprises

Identification

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

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

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 worst-case (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

Chemicals

• 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”)

Summary: The LEGO Groups identification/characterization/assessment (resins, inks, glue, lubricants etc)

Chemicals

• Find CAS-number (e.g through ESIS European chemical Substances Information System) http://esis.jrc.ec.europa.eu/

• Use table 3.1 in ANNEX VI of CLP (1272/2008) http://ec.europa.eu/enterprise/sectors/toys/documents/relevant-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 %)

Using the CLP

Chemicals

• If there is no SCL (Specific concentration limit) the general limits apply (until 2015 different limits may apply in DPD-directive 1999/45/EC).

Example from CLP:

Using the CLP (continued)

Chemicals

Inks, coatings, lubricants and glues• Normally possible to get SDS since solvents are used and thus

SDSs are elaboratedPlastics and paper• Possible to request Food contact material-certificates• For paper: Certificate regarding lead and optical agentsMetals• Test certificates for EN 71-3, Nickel release, Total lead.

Supplier certificate for CMRsTextiles• Test certificates for Azo-dyes• Request Ökotex-certification and certificate for formaldehyde

and NonylphenoleAdd REACH and when applicable RoHS

Alternatives to full BOS

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



InternalExternal

Yearly test

Raw material supplier

Yearly test

Batch size test at selected suppliers

Component supplier

Yearly test

Batch size test at selected suppliers

Part supplier

Visual inspection of set

of elements one time per

shift.

Moulding

Periodic visual

inspections by

operators.

Minimum frequency –

1x per hour.

Results of periodic in -

process inspections

must be documented.

Decoration

Random visual

inspection of assembled

elements

Assembly

1 internal sample per

5000 produced - used

for DPMO calculation

and reporting.

Prepack

1 internal sample per

2000 produced - used

for DPMO calculation

and reporting.

Yearly chemical test of

all play materials in the

product.

Final Pack

An example from the LEGO Group

The end

Thank you!

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