Directive 2005/84/EC of the European Parliament and of the Council of  14 December 2005  amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)
Date: 2005-12-14
Institutions: Council of the European Union, European Parliament
Subjects: dangerous substance, market approval, marketing standard, public health, toxic substance, toy industry

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Official Journal of the European Union

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DIRECTIVE 2005/84/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 14 December 2005

amending for the 22nd time Council Directive 76/769/EEC on the approximation of
the
laws, regulations and administrative provisions of the Member States relating to restrictions on
the marketing and use of certain dangerous substances and preparations (phthalates in toys
and childcare articles)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(5)

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

Commission Recommendation 98/485/EC 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 (4), invited Member
States to take measures to ensure a high level of child
health protection with regard to these products.

Having regard to the opinion of the European Economic and
Social Committee (2),

(6)

Acting in accordance with the procedure laid down in Article 251
of the Treaty (3),

Since 1999, the use of six phthalates in toys and childcare
articles intended to be placed in the mouth by children
under the age of three is subject to a temporary ban at
European Union level following the adoption of Commis-
sion Decision 1999/815/EC (5) in the framework of Coun-
cil Directive 92/59/EEC of 29 June 1992 on general
product safety (6). This Decision is being renewed regularly.

Whereas:

(1)

Article 14 of the Treaty establishes an area without inter-
nal frontiers in which the free movement of goods, per-
sons, services and capital is ensured.

(2) Work on the internal market should improve the quality of
life, health protection and consumer safety. This Directive
complies with the requirements of ensuring a high level of
health protection and of consumer protection in the defi-
nition and implementation of all Community policies and
activities.

(3)

The use of certain phthalates in toys and childcare articles
made of plasticised material or including parts made of
plasticised material should be prohibited as the presence of
certain phthalates presents or could potentially present
risks related to the health of children. Toys and childcare
articles which, although not intended for that purpose, can
be put in the mouth, may under certain circumstances
present a risk to the health of small children if they are
made of plasticised material, or include parts made of plas-
ticised material, which contains certain phthalates.

(4)

The Scientific Committee on Toxicity, Ecotoxicity and the
Environment (SCTEE), after being consulted by the Com-
mission, has delivered opinions on the health risks raised
by these phthalates.

(7)

(8)

(9)

Limitations already adopted by certain Member States on
the placing on the market of toys and childcare articles
because of their phthalate content directly affect the
completion and functioning of the internal market. It is
therefore necessary to approximate the laws of the Mem-
ber States in this field and consequently to amend Annex I
to Directive 76/769/EEC (7).

The precautionary principle should be applied where sci-
entific evaluation does not allow the risk to be determined
with sufficient certainty in order to ensure a high level of
protection of health, in particular for children.

Children as developing organisms are particularly vulner-
able to reprotoxic substances. Therefore, the exposure of
children to all practically avoidable sources of emissions of
these substances, especially from articles which are put
into the mouth by children, should be reduced as far as
possible.

(1) OJ C 116 E, 26.4.2000, p. 14.
(2) OJ C 117, 26.4.2000, p. 59.
(3) Opinion of the European Parliament of 6 July 2000 (OJ C 121,
24.4.2001, p. 410), Council Common Position of 4 April 2005
(OJ C 144 E, 14.6.2005, p. 24), Position of the European Parliament
of 5 July 2005 (not yet published in the Official Journal) and Council
Decision of 23 November 2005.

(4) OJ L 217, 5.8.1998, p. 35.
(5) OJ L 315, 9.12.1999, p. 46. Decision as last amended by Decision

2004/781/EC (OJ L 344, 20.11.2004, p. 35).

(6) OJ L 228, 11.8.1992, p. 24. Directive repealed by Directive
2001/95/EC of the European Parliament and of the Council (OJ L 11,
15.1.2002, p. 4).

(7) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commis-

sion Directive 2004/98/EC (OJ L 305, 1.10.2004, p. 63).

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(17)

(18)

(19)

(10) During risk assessments and/or within the framework of
Council Directive 67/548/EEC of 27 June 1967 on the
approximation of laws, regulations and administrative pro-
visions relating to the classification, packaging and label-
ling of dangerous substances (1), di(2-ethylhexyl) phthalate
(DEHP), dibutyl phthalate (DBP) and benzyl butyl phtha-
late (BBP) have been identified as reprotoxic substances and
have therefore been classified as reprotoxic, category 2.

(11)

(12)

Scientific information regarding di-isononyl phthalate
(DINP), di-isodecyl phthalate (DIDP) and di-n-octyl phtha-
late (DNOP) is either lacking or conflictual, but it cannot be
excluded that they pose a potential risk if used in toys
and childcare articles, which are by definition produced for
children.

The uncertainties in the evaluation of exposure to these
phthalates, such as mouthing times and exposure to emis-
sions from other sources, require that precautionary con-
siderations be taken into account. Therefore, restrictions
on the use of these phthalates for toys and childcare articles
and on the placing on the market of such articles should
be introduced. However, the restrictions for DINP, DIDP
and DNOP should be less severe than the ones proposed
for DEHP, DBP and BBP for reasons of proportionality.

In accordance with paragraph 34 of the Interinstitutional
Agreement on Better Law-making (2), Member States are
encouraged to draw up, for themselves and in the interest
of the Community, their own tables illustrating, as far as
possible, the correlation between this Directive and the
transposition measures, and to make them public.

The Commission will review the use of the phthalates listed
in Annex I to Directive 76/769/EEC in other products
when the risk evaluation under Council Regulation (EEC)
No 793/93 of 23 March 1993 on the evaluation and con-
trol of the risks of existing substances (3) will have been
concluded.

in

contained

of workers

This Directive applies without prejudice to Community
legislation laying down minimum requirements for the
Council
protection
Directive 89/391/EEC of 12 June 1989 on the introduc-
tion of measures to encourage improvements in the safety
and health of workers at work (4) and in individual direc-
in particular Council Directive
tives based thereon,
90/394/EEC of 28 June 1990 on the protection of work-
ers from the risks related to exposure to carcinogens at
work (5) and Council Directive 98/24/EC of 7 April 1998
on protection of health and safety of workers from the risk
related to chemical agents at work (6),

(13)

The Commission should review other applications of
articles made from plasticised material or including parts
made from plasticised material which may expose people
to risks, especially those used in medical devices.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

(14)

In line with the Commission Communication on the Pre-
cautionary Principle, the measures based on this principle
should be subject to review in the light of new scientific
information.

Directive 76/769/EEC is amended as follows:

1.

the following point shall be added to Article 1(3):

(15)

responsible for market

The Commission, in cooperation with the Member State
authorities
surveillance and
enforcement for toys and childcare articles, and in consul-
tation with the relevant organisations of producers
and importers, should monitor the use of phthalates and
other substances as plasticisers in toys and childcare
articles.

(16)

For the purpose of Directive 76/769/EEC, the term ‘child-
care article’ should be defined.

(1) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission

‘(c)

“childcare article” means any product intended to facili-
tate sleep, relaxation, hygiene, the feeding of children or
sucking on the part of children.’;

2. Annex I shall be amended as set out in the Annex to this

Directive.

(2) OJ C 321, 31.12.2003, p. 1.
(3) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(4) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC)

No 1882/2003.

(5) OJ L 196, 26.7.1990, p. 1. Directive repealed by Directive 2004/37/EC
of the European Parliament and of the Council (OJ L 158, 30.4.2004,
p. 50).

Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

(6) OJ L 131, 5.5.1998, p. 11.

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Article 2

The Commission shall re-evaluate, by 16 January 2010 at the lat-
est, the measures provided for in Directive 76/769/EEC as
amended by this Directive in the light of new scientific informa-
tion on substances described in the Annex to this Directive and
their substitutes, and if justified, these measures shall be modified
accordingly.

Article 3

1.
By 16 July 2006 Member States shall adopt and publish the
laws, regulations and administrative provisions necessary to com-
ply with this Directive. They shall forthwith inform the Commis-
sion thereof.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 4

This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

They shall apply these measures from 16 January 2007.

Done at Strasbourg, 14 December 2005.

When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such refer-
ence on the occasion of their official publication. The methods of
making such reference shall be laid down by Member States.

For the European Parliament
The President
J. BORRELL FONTELLES

For the Council
The President
C. CLARKE

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The following points shall be added to Annex I to Directive 76/769/EEC:

ANNEX

‘[XX.] The following phthalates (or other CAS- and EINECS
numbers covering the substance):

bis (2-ethylhexyl) phthalate (DEHP)
CAS No 117-81-7
Einecs No 204-211-0

dibutyl phthalate (DBP)
CAS No 84-74-2
Einecs No 201-557-4

benzyl butyl phthalate (BBP)
CAS No 85-68-7
Einecs No 201-622-7

[XXa.] The following phthalates (or other CAS- and
EINECS numbers covering the substance):

di-“isononyl” phthalate (DINP)
CAS No 28553-12-0 and 68515-48-0
Einecs No 249-079-5 and 271-090-9

di-“isodecyl” phthalate (DIDP)
CAS No 26761-40-0 and 68515-49-1
Einecs No 247-977-1 and 271-091-4

di-n-octyl phthalate (DNOP)
CAS No 117-84-0
Einecs No 204-214-7

Shall not be used as substances or as constituents of prepa-
rations, at concentrations of greater than 0,1 % by mass of
the plasticised material, in toys and childcare articles.

Such toys and childcare articles containing these phthalates
in a concentration greater than the limit mentioned above
shall not be placed on the market.

Shall not be used as substances or as constituents of prepa-
rations, at concentrations of greater than 0,1 % by mass of
the plasticised material, in toys and childcare articles which
can be placed in the mouth by children.

Such toys and childcare articles containing these phthalates
in a concentration greater than the limit mentioned above
shall not be placed on the market.’