1999/815/EC: Commission Decision of 7 December 1999 adopting measures prohibiting the placing on the market of toys and childcare articles intended to be placed in the mouth by children under three years of age made of soft PVC containing one or more of the substances di-iso-nonyl phthalate (DINP), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), di-iso-decyl phthalate (DIDP), di-n-octyl phthalate (DNOP), and butylbenzyl phthalate (BBP) (notified under document number C(1999) 4436) (Text with EEA relevance)
Date: 1999-12-07
Institutions: European Commission
Subjects: early childhood, plastics, product safety, public health, toxic substance, toy industry

L 315/46

EN

Official Journal of the European Communities

9. 12. 1999

COMMISSION DECISION

of 7 December 1999

adopting measures prohibiting the placing on the market of toys and childcare articles intended to
be placed in the mouth by children under three years of age made of soft PVC containing one or
more of the substances di-iso-nonyl phthalate (DINP), di(2-ethylhexyl) phthalate (DEHP), dibutyl
phthalate (DBP), di-iso-decyl phthalate (DIDP), di-n-octyl phthalate (DNOP), and butylbenzyl phtha-
late (BBP)

(notified under document number C(1999) 4436)

(Text with EEA relevance)

(1999/815/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 92/59/EEC of 29 June 1992
on general product safety (1), and in particular Article 9 thereof,

Whereas:

(1)

(2)

(3)

(4)

Pursuant to Article 3 of Directive 92/59/EEC, producers
are obliged to place only safe products on the market;
the Directive stresses in particular the need to ensure a
high level of protection of the health and safety of
children;

Article 9 of the Directive provides that the Commission
may, under certain conditions and in conformity with
the procedure set out in the Directive, adopt a decision
requiring Member States to take temporary measures to
prevent, restrict or submit to particular conditions the
placing on the market of a product, or requiring its
withdrawal from the market, if it presents a serious and
immediate risk to the health and safety of consumers;

The Commission may adopt such a decision with regard
to a product which,
in accordance with information
provided by a Member State, presents a serious and
immediate risk and in respect of which one or more
Member States have adopted measures entailing restric-
tions on the marketing of the product or requiring its
withdrawal from the market;

Such a decision is subject to the conditions that Member
States differ on the adoption of measures to deal with
the risk in question; that the risk cannot be dealt with in
a manner compatible with the urgency of the case under
the other procedures
specific
Community legislation applicable to the product or
category of products concerned; that the risk can be
eliminated effectively only by adopting appropriate
in order to
measures applicable at Community level,
ensure the protection of
the health and safety of
consumers and the proper functioning of the internal
market;

laid down by the

(1) OJ L 228, 11.8.1992, p. 24.

(6)

(7)

(8)

(9)

(10)

(11)

The Danish authorities have informed the Commission,
in four notifications presented in April and July 1997
under Article 8 of Directive 92/59/EEC, of the serious
and immediate risk presented by certain soft PVC
teething rings containing the phthalates DINP, DEHP,
DBP, DIDP, DNOP and BBP;

The Spanish authorities have informed the Commission,
in a notification presented in the same framework in
February 1998, of the risk presented by a soft PVC
imitation fruit containing the phthalate DINP, intended
for children;

The Greek authorities adopted on 15 January 1999
measures concerning the withdrawal from the market of
soft PVC childcare articles intended for teething by
infants and the prohibition of the import and marketing
of certain soft PVC toys intended for children under the
age of three years;

The Austrian authorities adopted on 4 August 1998 a
law prohibiting toys containing phthalates; intended for
children of less than three years of age, which are, under
normal and foreseeable conditions of use,
sucked,
chewed or otherwise frequently placed in the mouth;

The Danish authorities issued on 15 March 1999 a
Statutory Order prohibiting the production, import and
marketing of childcare articles intended or likely to be
placed in mouth, and of toys, and products which must
be expected to be used as toys by children under the age
of three years, or parts thereof, containing more than
0,05 % of phthalates;

The Swedish authorities adopted on 10 June 1999, a
measure prohibiting the marketing and sale of phthalate-
containing toys and childcare articles intended for chil-
dren under three years of age and which can be put in
the mouth;

The Finnish authorities adopted on 23 September 1999,
a Resolution of the Council of State prohibiting child-
care articles and toys which can be put into the mouth
by children under three years of age which are made of
soft PVC and contain more than 0,05 % by weight of
DINP, DEHP, DBP, DIDP, DNOP or BBP;

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Official Journal of the European Communities

L 315/47

(12)

(13)

(14)

The Italian authorities adopted on 30 September 1999 a
measure prohibiting the marketing of soft plastic toys
for children under three years of age intended or likely
to be put in the mouth, containing more than 0,05 % of
DINP, DIDP, DEHP, DBP, DNOP or BBP; in addition the
Italian authorities notified the Commission on 14 June
1999 within the framework of Directive 98/34/EC of
the European Parliament and of the Council (1) as last
amended by Directive 98/48/EC (2), of a draft measure
prohibiting the use of
four phthalates (DIDP, DEHP,
in plastic materials and elastomers and
DINP, DBP)
restricting the use of certain other phthalates to a
maximum of 5 % by weight in childcare articles;

The French authorities adopted on 5 July 1999 a
measure suspending the marketing, production, import
and export and ordering a withdrawal of certain toys
and childcare articles intended for placing in the mouth
by children under 36 months in soft PVC containing
DINP, DIDP, DEHP, DBP, DNOP and BBP; they have in
addition notified the Commission within the framework
of Directive 98/34/EC of a draft measure prohibiting the
use of DINP, DIDP, DEHP, DBP, DNOP and BBP in toys
and childcare articles intended for placing in the mouth
by children under three years of age;

The German authorities notified the Commission on 24
August 1999 within the framework of Directive 98/
34/EC of a draft measure prohibiting the marketing,
production and import of teething rings and certain
plastic toys for children up to three years of age entirely
or partly made of plastic materials, of which the plastic
parts are intended or can be foreseen to be put in the
mouth, containing more than 0,1 % of any phthalates;

(15) All

the abovementioned notifications and measures
relate to the risks associated with exposure of children to
phthalates and concern childcare products and/or toys
made of soft PVC containing certain phthalates which
are intended or Likely to be placed in the mouth by
young children;

(16)

The Commission adopted, on 1 July 1998 recommenda-
tion 98/485/EC (3) on phthalates in certain childcare
articles and toys, on the basis of the scientific knowledge
then available, inviting Member States to monitor the
level of phthalate migration from the products in ques-
tion, taking into account the opinion of the Scientific
Committee on Toxicity, Ecotoxicity and the Environ-
ment (SCTEE) of 24 April 1998, and to take the meas-
ures required to ensure a high level of child health
protection;

(17)

The Scientific Committee on Toxicity, Ecotoxicity and
the Environment (SCTEE), consulted by the Commission,
in its opinion on phthalates in toys of 27 November
1998, taking into account the results of the most recent

(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ L 217, 5.8.1998, p. 18.
(3) OJ L 217, 5.8.1998, p. 35.

relevant studies, has confirmed that there are grounds
for concern with the low safety margins as regards the
exposure of children to the phthalate DEHP and DINP,
in connection with the use of certain toys and childcare
articles made of soft PVC containing these substances;

(18)

(19)

(20)

(21)

(22)

The SCTEE has come to this conclusion on the basis,
inter alia, of adverse effects of DINP for liver and kidney
and testicular damage caused by DEHP observed in labo-
ratory tests;.
therefore appears that under certain
conditions these substances may have serious adverse
health effects:

it

In the light of the SCTEE opinion, the Commission
considers that young children who use certain toys and
childcare articles which are placed in the mouth, made
of phthalate-containing soft PVC, may be subject to daily
levels of exposure to DINP and DEHP higher than the
levels deemed to be safe;

The SCTEE found the release of the other phthalates
(DNOP, DIDP, BBP and DBP) to be low and to present
no risk under current conditions of use. The Committee
observed that a larger release would occur if they were
used as plasticisers in higher concentrations;

The Commission considers that, should the use of
DNOP, DIDP, BBP and DBP be allowed to replace DINP
and DEHP, as a consequence of the prohibition of these
two substances as plasticisers in the products in ques-
tion, the exposure of children to them would increase
and consequently the risk would be higher. Therefore,
the Commission, adopting a precautionary approach,
considers that this Decision should also apply to them;

Young children are also exposed to phthalates from
sources other than PVC toys and childcare articles, but
the level of exposure due to these sources cannot,
according to the SCTEE opinion, be quantified because
of lack of sufficient data; the existence of such additional
exposure should however be taken into account
in
managing the risks in question;

(23) Although the serious effects mentioned above do not
become manifest until some time after exposure, the risk
associated with the products in question is an immediate
one because it is directly associated with exposure to the
phthalates; such products. following the normal period
of use by a child, may lead to significant exposure with
serious effects later in life;

(24)

Therefore,
toys and
the Commission considers that
childcare articles for young children made of soft PVC
containing phthalates arc liable to present a serious and
immediate risk to health;

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Official Journal of the European Communities

9. 12. 1999

(25)

The products which pose the abovementioned risks are
toys and childcare articles which. are intended to be
placed in the mouth by young children and are made of
soft PVC containing one or more of the phthalates in
question, because they are expected to be placed in the
mouth for periods long enough and in a way liable to
give rise to daily phthalate-extraction above the levels
deemed to be safe; this Decision concerns, taken into
account the nature of the risk, both products produced
in the Community and imported products;

(26) Denmark, Austria, Greece, Finland, Sweden, Italy, France
and Germany have decided to submit
the products
belonging to the category in question to restrictive
measures with different scope, aimed at eliminating the
use of phthalates in this application; the Commission
has ascertained, that Member States differ on the adop-
tion of measures to deal with the risk in question;

Because of the differences between Member States and
between the scope of the measures taken by certain
Member States, a Community measure is necessary to
eliminate the risk and effectively ensure a consistent
high level of protection of child health and the proper
functioning of the internal market;

substances

as
applies

and preparations (1),

Council Directive 76/769/EEC of 27 July 1976 on the
the laws, regulations and adminis-
approximation of
the Member States relating to
trative provisions of
restrictions on the marketing and use of certain
last
dangerous
amended by Directive 1999/77/EC (2)
to
dangerous substances and preparations, but does not yet
concerning phthalates; Council
contain provisions
Directive 88/378/EEC of 3 May 1988 on the approx-
imation of the laws of the Member States concerning the
safety of
toys (3), as last amended by Directive 93/
68/EEC (4), as regards dangerous substances refers to the
relevant Community legislation relating to certain cate-
gories of products or to the prohibition, restriction of
use or labelling of certain dangerous substances and
preparations; it does not apply to childcare articles and
does not provide for an emergency procedure;

(27)

(28)

(29)

(30)

The Danish authorities requested the Commission on 15
April 1998 to adopt a decision introducing restrictive
measures in relation to the products in question,
in
compliance with Article 9 of Directive 92/59/FEC;

in its

The European Parliament,
resolution on a
consumer policy action plan, adopted on 4 May 1999,
has called on the Commission to take steps in removing
phthalates from PVC toys intended for babies and young
children (5);

(35)

(1) OJ L 262, 27.9.1976, p. 201.
(2) OJ L 207, 6.8.1999, p. 18.
(3) OJ L 187, 16.7.1988, p. 1.
(4) OJ L 220, 30.8.1993, p. 1.
(5) OJ C 279, 1.10.1999, p. 86.

(31)

(32)

(33)

(34)

SCTEE,

consulted by

the Commission. has
The
concluded in its opinion of 28 September 1999 on
TNO, LGC and United States CPSC reports on phthalate-
migration test validation that none of the phthalate-
migration test methods which have been subject to vali-
control
currently
dation attempts
purposes;

suitable

for

is

In the absence of a test method of phthalate migration
that has been validated and standardised at Community
level, it is not currently feasible to guarantee a consis-
tently high level of child health protection by laying
down limits on the migration of these substances from
the toys and childcare articles in question, and to ensure
standard and non-discriminatory application of
these
limits; furthermore it is at present very difficult to estab-
lish phthalate migration limits which take account of the
contribution to phthalate child exposure from sources
other than PVC toys and childcare articles;

The scientific evidence on phthalate migration-test
methods mentioned above, which has been made avail-
able recently, has shown that Recommendation 98/
485/EC is not sufficient to ensure a consistent high level
of child health protection; it is now urgent to prohibit
rapidly the placing on the market of toys and childcare
articles intended to be placed in the mouth by children
under three years, because it has now become evident
that there is no other effective control measure currently
available for regulatory purposes;

The Commission has presented a proposal
for an
amendment to Directive 76/769/EEC on restrictions on
the marketing and use of dangerous substances and
preparations prohibiting, the use of DINP, DEHP, DIDP;
DNOP, DBP and BBP in toys and childcare articles made
of soft PVC and intended to be put in the mouth by
children under the age of three. Furthermore, the placing
on the market of such products is not allowed if they
contain the mentioned phthalates; the proposal aims, in
addition, at ensuring that other
toys and childcare
articles of soft PVC intended for children under the age
of three and which could be put in the mouth should
bear a label in order to ensure that the children do not
put them in the mouth;

In order to ensure a consistent high level of child health
protection throughout the EU, in the period preceding
the adoption by the European Parliament and the
Council of the proposed Directive and its implementa-
tion by the Member States, and given that toys and
childcare articles of soft PVC containing phthalates
intended for placing in the mouth by children under
three years of age present a serious and immediate risk,
it is necessary to prohibit immediately their placing on
the market;

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L 315/49

(36) All

the relevant phthalates must be covered by this
Decision in order to eliminate those which are presently
used and prevent use of the others which pose compar-
able risks for child health;

(37)

(38)

(39)

(40)

This Decision should eliminate the deliberate use of the
relevant phthalates as plastisizers in the products in
question. while acknowledging the possibility of their
presence at a trace level of up to 0,1 % by weight which
is considered a level allowing for non-intended impuri-
ties not giving rise to concern for child health;

The duration of the validity of this Decision is limited to
three months; period of validity may be prolonged if
necessary;

to Article 11(3) of Directive 92/59/EEC
Pursuant
Member States shall
take all necessary measures to
implement the decision adopted within less than 10
days;

The measures provided for in this Decision are in
accordance with the opinion of
the Emergencies
Committee,

HAS ADOPTED THIS DECISION:

Article 1

This Decision shall apply to toys and childcare articles:
— made of, or in part made of; soft PVC containing more than
the following

0,1 % by weight of one or more of
substances:
— di-isononyl phthalate (DINP) CAS No 28553-12-0

Einecs No 249-079-5,

— di(2-ethylhexyl) phthalate (DEHP) CAS No 117-81-7

Einecs No 204-211-0,

— di-n-octyl phthalate (DNOP) CAS No 117-84-0 Einecs

No 204-214-7,

— di-iso-decyl phthalate (DIDP) CAS No 26761-40-0

Einecs No 247-977-1,

— butyl benzyl phthalate (BBP) CAS No 85-68-7 Einecs

No 201-622-7,

— dibutyl phthalate (DBP) CAS No 84-74-2 Einecs No

201-557-4,

— intended to be placed in the mouth by children of less than

three years of age.

Article 2

For the purposes of this Decision:
— a ‘toy’ shall mean any product designed or clearly intended

for use in play by children,

— childcare article shall mean any product intended to facili-
tate sleep, relaxation. the feeding of children, or sucking on
the part of children.

Article 3

Member States shall prohibit the placing on the market of the
toys and childcare articles referred to in Article 1.

Article 4

Member States shall take the measures necessary to comply
with this Decision within less than 10 days of its notification.
They shall forthwith inform the Commission thereof.

This Decision shall be applicable until 8 March 2000.

Article 5

This Decision is addressed to the Member States.

Article 6

Done at Brussels, 7 December 1999.

For the Commission

David BYRNE

Member of the Commission