Chemicals of concern in

toys and children products

Which hazardous substances in which

products, which effects on human

health and how to reduce exposure?

Elisabeth Ruffinengo, Advocacy Officer WECF

elisabeth.ruffinengo@wecf.eu

Workshop Hazardous chemicals in consumer products, Vilnius

March 25th 2014

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Introduction The context:

Science Global recognition by scientists of the health impact of

environmental perinatal exposures (like EDCs): in utero development

periods and early childhood are considered especially vulnerable. (PPTox

III Statement, UNEP/WHO report on Endocrine Disruptors, etc.)

Policy EU REACH regulation is 7 years, Toys Safety Directive (July

2013), Biocides Regulation (Sept 2013), development of EDCs Strategies

and chemical plans in the EU and in MS (France, Sweden, Denmark, etc.),

US-EU TTIP negotiations

Chemicals on the market over 100,000 worldwide, globalized

market, production shifting to developing countries, waste issue,

occupational exposure, environmental pollution

Society demand for safer chemicals/alternatives, contribution of the civil

society (campaigns, advocacy activities, etc.)

Children’s vulnerabilityImmature & developing organisms

(immune, nervous, endocrine system,

organs, etc.)

+

Size and weight of children

(proportionally increased the exposure

compared to adults with same burden of

exposure)

+

Behaviours: hand-mouth contacts,

exploratory behaviour, sucking products,

playing on the ground, etc. (dermal, oral,

respiratory absorption)

=

increased effects of toxic exposures on

the health of the child and future adult

I) Chemicals of concern in children’s

articles (focus on EDCs and toys)

II) EU and Member States legislation

that protect children

III)Principles to reduce exposure to

chemicals of concerns (illustration with

some WECF activitities)

I – Chemicals of concern in children’s

products

• CMR substances: carcinogenic, mutagenic and reprotoxic

compounds

• metals (lead - neurotoxic), cadmium, nickel, barium, etc.)

• allergens

• sensitizers

• endocrine disruptors (bisphenol A, parabens, phthlates, etc. )

• neurotoxicants,

• immunotoxics,

• POPs,

• PBT, vPvB,

• biocides, etc.

A) Chemicals of concern in toys

• DEHP (phthalate) in soft

plastic – most commonly

found

• DINP, DBP (phthaltes)

• Nickel (metallic tea set)

• Lead (in electric toys)

• Certain azo-dyes releasing

aromatic amines (fancy

dresses)

• Cadmium (packaging)

Plus non-tested substances?

Source: RAPEX database

EDCs in toys

Data gap: Lack of data on EDCs use in toys

Regulatory gap: not regulated under TSD

• Bisphenol A:

EDC, reproductive, developmental and systemic toxicant, weakly

estrogenic, etc. – soon to be classified as “reprotoxic 1B”

KEMI (2012): no risk from BPA use in toys but the global exposure

to BPA of a child may vary depending of other sources

US Survey (2011): BPA found in 280 hard plastic toys

• Phtalates:

DEHP, BBP, DBP ban in all toys and childcare artilces

DIDP, DINP, DnOP bann in toys that can be placed in the mouth (3

years of age – 4 years in Canada)

Other phthalates (DiBP, DINCH, etc. ) still in use

2 issues: low dose + combined effect

Metal elements in toysLead

• Long-known neurotoxicant (IQ

loss, ADHD, etc.)

• Regulated by TSD: authorized

concentrations under review

since 2009, still no agreement

of the toys safety committee

• No « safe » threshold of lead

exposure identified

Cadmium

• carcinogen 1B

• mutagen and reproductive

toxicant 2

• linked to lung, kidney and

prostate cancer in workers

• Suspected to be linked to

mental retardation, learning

disability and IQ loss (Harvard

University study, 2012)

Compound Dry

material

(mg/kg)

Liquid material Scrapped-off

material

TSD 2009 Cd 1,9 0,5 23

2011 lowered Cd 1,3 0,3 17

TSD 2009

Under review

Pb 13,5 3,4 160

TSD 2009 Ba 4500 1125 56 000

2013 lowered Ba 1500 375 18750

TSD 2009 Hg 7,5 1,9 94

TSD 2009 Al 5625 1406 70 000

What about

authorized

levels of other

elements?

Hg? Al?

etc.

Allergenic preservatives in toys

Danish Environment Agency, Survey Febr 2014:

Regulatory gap: allergenic compounds other than fragrances not

regulated by TSD

finger paint, modelling clay, cosmetics, face paint, glue, slime,

soap bubbles and hobby paint

23 different preservatives identified

11 pieces of toys analysed for 16 different preservatives

Outcome: Cosmetic Products Directive limits seem to be used as

a guideline

formaldehyde - strongly allergenic, persons allergic to

formaldehyde can get allergenic reactions already at low

concentrations (60 ppm). 2 of 11 products > 60 ppm

kathone - still used in toys, despite EU’s Scientific Committee

on Health and Environmental Risks (SCHER) recommends:

Kathon, MI, MCI (constituents in Kathon) shall not be used in

toys due to the allergenic properties of the substances.

Survey of toys manufacturers/retailers:

KEMI, sept 2013:

• 44 toys companies

• variety of knowledge of

existing legislations

• 211 toys tested

• 53 contained hazardous

substances in prohibited

concentrations (phthalates in

soft plastics and lead in

electric toys were the most

commonly found

WECF, dec 2012 (France):

• 16 big toys

companies/retailers

surveyed on preparation of

implementation of new TSD,

• 6 replies

• only 1 replies to have taken

out of its collection 1 toy

incompatible with new

requirements

• global lack of transparency

B) chemicals of concern in other articlesBisphenol A: lining of tin cans,

cash receipts, food contact materials, etc.

Other bisphenols’ (BPS, etc.) use as alternatives

Parabens: cosmetics, food, etc.

Methylhexyl ethoxycinamate (EDC): cosmetics

Nonylphenol ethoxylates: children’s wear, textiles, mattresses,

household paints, etc.

Flame retardants (TBBPA, etc.): furniture, electronics, etc.

Phthalates: DINP, DIDP, DiOP, DEHP etc. in food, consumer

products, fancy dresses, school supplies, etc.

Metals : Lead, mercury, nickel, cadmium, aluminium: food

contamination, and consumer products

US survey (2013) :

phthalates in more than 770 children’s products (baby car

seats, changing mats, bedding, clothes, Halloween masks, etc.) http://www.environmentalhealthnews.org/ehs/news/2013/phthalates

Illustrations (RAPEX, KEMI, other

studies) • Chromium VI (leather article)

• Lead, cadmium, nickel

(jewelry, etc.)

• Benzene and solvents (in

marker pens)

• DINP, DEHP (children’s

chair)

• Azo-dyes (release of

aromatic amines)

• PAHs (toys, hair dyes, etc.)

• Short Chain chlorinated

Paraffins (POPs) in plastic

bag of toys

II) EU and Member States legislation

that protect children

Toys Safety Directive

2009/48/EC :

• CMR 1A, 1B, 2 banned but

derogations

• Migration limits for 19

elements (Pb, Cd, As, etc.)

• Ban of 55 allergenic

fragrances

• Mandatory labelling of 11

allergenic fragrances

• Nitrosamines and nitrosables

substances (0,05 to 1 mg/kg in

toys for children under 3 or

placed in the mouth)

• 6 phthalates ban/restriction

Recent evolutions :

2014:

• Bisphenol A – migration limit

(0,1mg/l)

• TCEP, TCPP and TDCP (3

flame retardants) - 5 mg/kg

• Nickel – new exemption for

use in toys granted

• PAHs (REACH amendment

– content of 0,5 mg/kg as

from 2017)

2009-2013:

• Cd limits lowered

• Ba limits lowered

RAPEX & market surveillance in the EU

January 2014 statistics:

• Toys: 44 notifications (23%),

• Clothing, textiles and

fashion items: 43

notifications (22%),

• Chemical risk: 44

notifications (20%),

• majority of the dangerous

products notified originated

from China, including Hong

Kong (123 notifications,

64%)

How many substances are

investigated? Mostly know

phthalates, some heavy metals

(former REACH covered

substances), but what about

other chemicals?

In 2012 in France, on 299 toys

tested for heavy metals, only

16% fulfill legal requirements(source: DGCCRF, France)

B) Member States approaches:

France• 2nd H&E action plan 2009-

2013 with a focus on children’s

health and vulnerable

populations

• Indoor air quality

• Chemicals

• Pesticides

• etc.

• 3rd action plan in preparation

(febr-sept 2014)

• Communication, training

• Chemicals & diseases

• Global exposures

EDCs Strategy:

• WG (NGOs, industry, MoE,

MoH, research bodies, etc.)

Febr-July 2013

• public consultation (July-sept

2013)

Waiting for release of the

Strategy by mid-2014

Delay of the publication

BPA ban: in food contact

materials – under 3 and from

January 2015 all food contact

materials

ANSES study on chemicals in toys and

childcare articles

Scope: Investigate the presence of 20 substances

(phthalates, other plasticizers, flame retardants, etc.) in childcare

articles and toys for under 3 - May 2013-end 2014

Denmark

• Phthalates Strategy:

• ban of 4 phthalates in a wide range of consumer products

(0,1%) and all phthalates have been banned in Denmark in toys

and childcare articles for children aged 0-3 years in

concentrations higher than 0.05%

• Ex: in 2010, a study shows sun lotion increases the exposure to

phthalates from plastic shoes

• Chemical Action Plan 2010-2013 (ex: focus on EDCs and

cocktail effects) - new plan 2014-2017 focuses on focuses on

chemicals of concern in products for children and young people

• Surveys on chemicals in consumer products

• Publications and awareness raising for children and pregnant

women

• List of undesired substances (LOUS)

Sweden

• Action Plan for a toxic-free environment 2011-2014

• Increased number of inspections and analysed articles in 2013:

On 550 toys tested, only 12% comply with legislation

• Report on chemicals in textiles, 2013

• Strong support of the adoption of EDCs criteria at EU level

Germany

• Safeguard clause use to ensure lower contents of chemicals

than planned by new TSD and maintain more protective national

legislation

On lead, barium, cadmium, nitrosamines and nitrosable

substances, PAHs

Outcomes:

• Ba, Cd limits lowered

• PAHs, new European legislation (REACH amendment) : for

toys, including activity toys, and childcare articles: new limit

value of 0.5 mg/kg in concentration not implemented before 27th

December 2015

III) Principles to reduce exposure to

chemicals of concern

Situation:

Is the public aware of the risks?

Does it know about its rights to information?

Ex: EU REACH regulation 1997/2006 – a right to know on chemicals of

concern in products of article 33 is generally a right ignored, and

consequently not used

Ex: RAPEX EU website in English only

http://ec.europa.eu/consumers/dyna/rapex/create_rapex.cfm?rx_id=496

Is environmental information available?

Where?

Under which form? understandable by the general public?

When identified, does the public know how to reduce the risks (if

possible to do so)?

Illustration: concerns of parents-to-be on

chemicals in products

• Precise questions

Which paint/decoration product shall I choose for a newborn

bedroom?

What are the ingredients of the mattress I just bought for my

baby?

Is this toy containing phthalates?

• Need for quick reaction

• Want concrete solutions

• Role of NGOs to convey information in a context of a relative

loss of confidence in public authorities (following health,

environment scandals)?

Key principles

1) Reduce exposure at the source is the best way to avoid extra

communication/information costs and to ensure a better health

and environment protection, as well save costs of disposal of

hazardous substances/articles

2) Implement the clause of the « best protected child in the EU »

to harmonize legislations

3) Transparency on behalf of manufacturers to enhance the

knowledge of official risk assessment bodies and allow proper

assessment of combined/real life exposures

4) Centralized contacts & accessibility of information for the

public to allow wide dissemination of information

5) Format of the information as well as labelling where existing

must be adequate to allow understanding, and acess made

through user-friendly tools

Some WECF activities : 2013

• Toys testing at European

Parliament

• Toys petition to ban EDCs in

toys receives 30,000

signatures

• Working group on EDC

Strategy (FR)

• NGOs Statement « EDCs:

Time to act », France, with

campaign partners

• Workshop on toys eco-

design, Paris, 120 participants

• EDC-free coalition action,

Brussels

WECF pocket guides

ConclusionEU chemical policy has now reached a turning point:

• A substantial body of robust scientific evidence is available

worldwide on the need to reduce in utero and early life exposure to

hazardous chemicals (EEA, UNEP, WHO, etc.) taking into account

combined exposure and low doses

• EU Horizontal adoption and implementation of EDCs criteria and

strategy is urgently needed

• Coherence among EU regulatory instruments is needed

• Commercial and trade interests should no more prevail over health

and environment : precautionary principle should be implemented

for the benefit of populations

THANK YOU!

www.wecf.eu www.projectnesting.org/