Common Position (EC) No 22/2005 of 4 April 2005 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council 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: 2005-04-04
Institutions: Council of the European Union
Subjects: child, dangerous substance, principle of subsidiarity, product safety, toy industry

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COMMON POSITION (EC) No 22/2005

adopted by the Council on 4 April 2005

with a view to adopting Directive 2005/…/EC of the European Parliament and of the Council of …
amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regu-
lations 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 child-
care articles)

(2005/C 144 E/04)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Commission, has delivered opinions on the health risks
raised by these phthalates.

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

(5)

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

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

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

Whereas:

(1)

Article 14 of the Treaty establishes an area without
internal frontiers in which the free movement of goods,
persons, 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 protec-
tion in the definition and implementation of all Com-
munity policies and activities.

(3)

The use of certain phthalates in toys and childcare arti-
cles made of plasticised material or including parts made
of plasticised material
should be prohibited as the
presence of certain phthalates presents or could poten-
tially present risks related to the health of children.

(4)

The Scientific Committee on Toxicity, Ecotoxicity and
the Environment (SCTEE), after being consulted by the

(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 and
Position of the European Parliament of … (not yet published in the
Official Journal).

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 phtha-
lates (4),
invited Member States to take measures to
ensure a high level of child health protection with
regard to these products.

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

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
Member States in this field and consequently to amend
Annex I to Council Directive 76/769/EEC (7).

The precautionary principle should be applied where
scientific evaluation does not allow the risk to be deter-
mined 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.

(6)

(7)

(8)

(9)

(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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(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
provisions relating to the classification, packaging and
labelling of dangerous substances (1), DEHP, DBP and
BBP have been identified as reprotoxic substances and
have therefore been classified as reprotoxic, category 2.

(18)

This Directive applies without prejudice to Community
legislation laying down minimum requirements for the
protection of workers contained in Council Directive
89/391/EEC of 12 June 1989 on the introduction of
measures to encourage improvements in the safety and
health of workers at work (4) and in individual directives
based
Council Directive
particular
90/394/EEC of 28 June 1990 on the protection of
workers from the risks related to exposure to carcino-
gens 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),

thereon,

in

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 76/769/EEC is hereby amended as follows:

1. The following subparagraph shall be added to Article 1(3):

‘(c) “childcare article” means any product intended to facili-
tate sleep, relaxation, 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.

Article 2

The Commission shall re-evaluate, by … (*) at the latest, the
measures provided for in Directive 76/769/EEC as amended by
this Directive in the light of new scientific information 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 … (**) Member States shall adopt and publish the
laws, regulations and administrative provisions necessary to
comply with this Directive. They shall forthwith inform the
Commission thereof.

They shall apply these measures from … (***).

(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).
(6) OJ L 131, 5.5. 1998, p. 11.
(*) Four years after entry into force of this Directive.
(**) Six months after entry into force of this Directive.
(***) Twelve months after entry into force of this Directive.

(11)

(12)

(13)

(14)

lacking or conflicting, but

Scientific information regarding DINP, DIDP and DNOP
is either
it can not 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
emissions from other sources, require that precautionary
considerations be taken into account. Therefore, restric-
tions on the use of these phthalates for toys and child-
care 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 line with the Commission Communication on the
Precautionary Principle, the measures based on this prin-
ciple should be subject to review in the light of new
scientific information.

The Commission, in cooperation with the Member State
authorities responsible for market surveillance and enfor-
cement for toys and childcare articles, and in consulta-
tion with the relevant organisations of producers and
importers, should monitor the use of phthalates and
other substances as plasticisers in toys and childcare arti-
cles.

(15)

For the purpose of Directive 76/769/EEC,
‘childcare article’ should be defined.

the term

(16)

(17)

in accordance with paragraph 34 of the
The Council,
law-making (2),
Interinstitutional agreement on better
should encourage Member States to draw up, for them-
selves and in the interest of the Community, their own
tables, which will, as far as possible, illustrate the corre-
lation 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 Regu-
lation (EEC) No 793/93 of 23 March 1993 on the
existing
evaluation and control of
substances (3) will have been concluded.

risks of

the

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

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

(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).

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

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 twentieth day
following its publication in the Official Journal of the European
Union.

Article 5

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament

The President

…

For the Council

The President

…

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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-
the

numbers

Einecs

covering

and
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-
the

Einecs numbers

covering

and
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 preparations, at
concentrations of greater than 0,1 % by mass of the plasticised mate-
rial, 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 preparations, at
concentrations of greater than 0,1 % by mass of the plasticised mate-
rial, in toys and childcare articles intended for children under three
years of age and which can be placed in the mouth by them.

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

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STATEMENT OF THE COUNCIL REASONS

I. INTRODUCTION

The Commission submitted to the Council and to the European Parliament its proposal for amending
for the 22nd time Directive 76/769/EEC on 24 November 1999 (1), based on Article 95 of the EC
Treaty.

The European Economic and Social Committee delivered an opinion on 15 February 2000 (2).

The European Parliament completed its first reading and delivered an opinion on 6 July 2000 (3).

On 4 April 2005, the Council adopted its Common Position as set out in Document 5467/05.

II. OBJECTIVE

The draft Directive relates to the marketing and use of toys and childcare articles containing phthalates.
In its original form it foresaw prohibition of six different phthalates in toys and childcare articles
containing PVC and intended to be put in the mouth by children under the age of three years.

The European Parliament,
proposing some amendments to the Commission proposal. The main amendments are the following:

in its first reading, adopted a resolution on phthalates and toy safety

— in the case of toys that contain phthalates and are intended for children between the ages of three
and six, but which younger children could place in their mouths, warnings must be placed on the
packaging and on the toy itself,

— the prohibition should apply to all phthalates and not only to the six contained in the Commission

proposal,

— the ban should be extended to all toys, not just toys intended for children under three, and not
only toys that are designed to be placed in the mouth. Toys which can be placed in the mouth by
children may have concentrations no greater than 0.1 %, rather than 1 % as envisaged in the
Commission proposal,

— fragrances may not be added to toys, containing phthalates, which a child can place in its mouth.

On 25 May 2000, the Council examined the file but was not able to reach agreement on a common
position.

Meanwhile, the results of new risk assessments had become available, and it seemed desirable to
strengthen some of the original provisions, in line with what the European Parliament had concluded.
On 24 September 2004, the Council reached a political agreement by unanimity on the draft Directive,
amending for the 22nd time Directive 76/769/EEC, as set out in Annex I to Document 12469/04.

III. ANALYSIS OF THE COMMON POSITION AS SET OUT IN DOCUMENT 5467/05

1. General

Though not incorporating all amendments of the European Parliament, the common position
broadens considerably the scope of the ban, by replacing labelling with an outright ban and ensures
legal certainty by clearly defining the items which fall within the scope of the ban (a definition of
childcare article, identical to the one contained in the Toys Decision (4), has been added).

(1) OJ C 116 E, 26.4.2000, p. 14.
(2) OJ C 117, 26.4.2000, p. 17.
(3) OJ C 121, 24.4.2001, p. 410.
(4) Commission Decision 1999/815/EC (OJ L 315, 9.12.1999, p. 46).

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Amendments 1, 3, 4, 6 and 8 have been accepted in principle, though redrafted.

Amendments 18, 2, 5, 11, 24, 7, 17/rev., 16 and 9 have not been deemed acceptable.

2. New elements contained in the Common Position as compared with the Commission

proposal

Recitals 3, 4 and 7 have undergone minor drafting changes, mostly of a legal nature. New recitals 6
and 9 to 15 have been added, to indicate that a temporary ban is already in force and to clarify the
relationship between the phthalates to be banned, the precautionary principle and the risk assess-
ment procedures.

The definition of 'childcare article' has been introduced in the new Article 1(1).

Article 2 has been redrafted to introduce the obligation for the Commission to review these
measures within four years from their entry into force.

Article 3 has been redrafted to comply with the guidelines on drafting legislative texts, and to add
the obligation for Member States to notify the transposition measures to the Commission.

In the Annex, the scope of the ban has been clarified, by extending it, for DEHP, DBP and BBP, to
all toys and childcare articles; for DINP, DIDP and DNOP, the ban will cover toys and childcare arti-
cles intended for children under three years of age and which can be placed in the mouth by them.
In both cases, it has been clarified that the concentration limit of 0,1 % of the mass applies to the
plasticised material mass, so that in case of items which include both plasticised material and other
components, it remains applicable in full to the plasticised part only.

IV. CONCLUSION

The Council, through its Common Position, wishes to move forward in the same direction as the Euro-
pean Parliament, by significantly broadening the scope of the ban, replacing labelling with an outright
ban. The Council believes that this will greatly assist towards adopting a permanent ban, subject to a
continuous review, leading to an even broader ban, should new scientific evidence arise after its entry
into force.