98/485/EC: Commission Recommendation of 1 July 1998 on childcare articles and toys intended to be placed in the mouth by children of less than three years of age, made of soft PVC containing certain phthalates (notified under document number SEC(1998) 738)
Date: 1998-07-01
Institutions: European Commission
Subjects: early childhood, plastics, product safety, public health, toy industry

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Official Journal of the European Communities

L 217/35

COMMISSION

COMMISSION RECOMMENDATION

of 1 July 1998

on childcare articles and toys intended to be placed in the mouth by children of
less than three years of age, made of soft PVC containing certain phthalates

(notified under document number SEC(1998) 738)

(98/485/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

protection in regard to these products, pending the
implementation of permanent Community measures;

Having regard to the Treaty establishing the European
Community, and in particular Article 155, second indent,
thereof,

Whereas, pursuant to the Treaty establishing the Euro-
pean Community, the Community must contribute to the
attainment of a high level of consumer health protection;

Whereas, pursuant to Article 3 of Council Directive 92/
59/EEC of 29 June 1992 on general product safety (1),
only safe products may be placed on the market; whereas
the Directive emphasises in particular the need to ensure
a high level of protection for the health and safety of
children;

Whereas the Sientific Committee on Toxicity, Ecotoxicity
and the Environment (SCTEE), after being consulted by
the Commission, delivered an opinion on 24 April 1998,
supplemented by clarifications on 16 June 1998, on the
effects on the health of children of the use of certain
phthalate-containing soft PVC toys and childcare articles;
whereas in this opinion it expressed its concern about the
exposure of children to some of these phthalates;

Whereas the SCTEE has in particular recommend that
certain limit values for the migration of the phthalates
DINP, DEHP, DBP, DIDP, DNOP and BBP released by
soft PVC toys and childcare articles intended to be placed
in the mouth by children of less than three years of age
should not be exceeded;

Whereas it is important that Member States take the
measures required to ensure a high level of child health

Whereas the said migration limit values are liable to be
exceeded in certain cases; whereas it is therefore im-
portant that the Member States proceed, in the context of
appropriate checks, to monitor the level of exposure of
children to phthalates which may be caused by the migra-
tion of these substances when using the products in ques-
tion;

is important

Whereas it
that Member States should
exchange information on the test and measurement
methods used in these checks and on the results obtained
and that they should collaborate among themselves and
with the Commission in order to achieve as consistent as
possible
the Community,
pending the adoption of a standardised method;

an approach throughout

Whereas it is appropriate in the context of this collabora-
tion, to examine, inter alia, the results of the ongoing
study in the Netherlands concluded by the Rijksinstituut
voor Volksgezondheid en Milieu (RIVM), which may
make it possible to define a common reference method;

Whereas, whenever a Member State restricts the placing
on the market of products covered by this recommenda-
tion, it must inform the Commission in line with the
procedure prescribed in Article 7 of Directive 92/59/EEC
on general product safety, in the case of childcare articles,
Article 7 of Council Directive 88/378/EEC (2) of 3 May
1988 on the safety of toys, in the case of toys, or in
accordance with the Article 8 procedure of Directive 92/
59/EEC,
there is a serious and
immediate risk and, where appropriate, proceed to notify
the Commission in compliance with Council Directive

it considers that

if

(1) OJ L 228, 11. 8. 1992, p. 24.

(2) OJ L 187, 16. 7. 1988, p. 1.

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83/189/EEC of 28 March 1983 laying down a procedure
for the provision of information in the field of technical
standards and regulations (1),

HEREBY RECOMMENDS:

Article 1

1. Member States shall adopt the measures required to
ensure a high level of child health protection in regard to
phthalate-containing soft PVC childcare articles and toys
intended to be placed in the mouth of less three years of
age, and notably 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).
Particular attention should be paid to the substances
DINP and DEHP.

In vetting the products in question, Member States
2.
shall monitor the levels of migration of these substances
in the context of appropriate checks, taking into account
the opinion on phthalates in toys delivered by the
Scientific Committee on Toxicity, Ecotoxicity and the
Environment (SCTEE) on 24 April 1998 and notably the
migration limit values for phthalates released by these
products
recommended by this Committee and re-
produced in the Annex.

3. Member States shall regularly inform the Commis-
sion of the test methods and measurement methods used
to determine the levels of migration in question, the
the checks, and the conclusions they have
results of

reached; Member States are invited to furnish initial infor-
mation before the end of August 1998.

4. Member States shall participate in the exchange of
information with other Member States and in work to
ensure a consistent approach to test and measurement
methods and to identifying a common method, which
will be organised by the Commission.

Article 2

For the purpose of this recommendation,

(1)

(2)

toy: means any product designed or clearly intended
for use in play by children,

childcare article: means any product designed to
facilitate sleep, relaxation, the feeding of children, or
sucking on the part of children.

Article 3

This recommendation is addressed to the Member States.

Done at Brussels, 1 July 1998.

For the Commission

Emma BONINO

Member of the Commission

(1) OJ L 109, 26. 4. 1983, p. 8.

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ANNEX

Substance

Maximum tolerable extractable quantity (1)
(mg)

DINP

DNOP

DEHP

DIDP

BBP

DBP

1,2

3,0

0,4

2,0

6,8

0,8

(1) These quantities relate to a sample with a surface of 10 cm2, over a test period of six hours, for a child weighing 8 kg.