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 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)

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 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.

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
Decision
OK? 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

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

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

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

Example of LEGO “Element risk assessment”

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
found in TSD, Annex II - Parts V and VI

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

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.

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
Make sure the toy can be
cleaned. Add cleaning

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

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
found in TSD, Annex II – Part III

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

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.

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)

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)

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
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

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

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)

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
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

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 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

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”)

Chemicals
Using the CLP
• 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/rele
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 %)

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:

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

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

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.

The end

Thank you!

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