Proposal for a Directive of the European Parliament and of the Council amending for the 22nd time 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) and amending Council Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys
Date: 1999-11-10
Institutions: European Commission
Subjects: child, dangerous substance, principle of subsidiarity, product safety, toy industry

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 10.11.1999
COM(1999) 577 final

1999/0238 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending for the 22nd time 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)
and amending Council Directive 88/378/EEC on the approximation of the laws of the
Member States concerning the safety of toys

(presented by the Commission)

EXPLANATORY MEMORANDUM

1.

INTRODUCTION AND CONTEXT

In 1997 Denmark and in 1998 Spain notified the Commission, in the framework of Directive
92/59/EEC1 on general product safety, about health risks to small children through the release
of phthalates from certain child-care articles and toys made of PVC and intended for
mouthing. The phthalates are plasticisers used to soften the PVC. The Commission requested,
in October 1997, the Commission’s Scientific Committee on Toxicology and Ecotoxicology
and the Environment (SCTEE) to give its opinion.

In a first opinion delivered in February 1998 (updated in April and June the same year) the
SCTEE reviewed the risks posed by phthalates and established migration limits for phthalates
in soft PVC toys. As a short term measure the Commission adopted a Recommendation in
July 1998 (98/485/EC) based on the work of the Scientific Committee. The Recommendation
concerns child care articles and toys intended to be placed in the mouth by young children of
less than three years of age and made of soft PVC containing certain phthalates. Member
States are asked to adopt the measures required to ensure a high level of child health
protection taking into consideration the opinion of the SCTEE. The SCTEE delivered a new
opinion based on the latest scientific information in November 1998 expressing « some
concern » on the most commonly used phthalate (DINP), and « serious concern » on another
one (DEHP). It was furthermore concluded that the use of these phthalates in toys put in the
mouth by children, did not respect the recommended safety margin. Exposure to DINP and
DEHP from other sources than soft PVC toys will, according to the Committee, increase the
concern but the magnitude of such exposures is uncertain. The existence of such additional
exposure should be taken into account in managing the risks in question.

Two approaches to reduce the risks to children of phthalates have been considered, i.e. to
establish limits for migration of phthalates from toys and to ban the use of phthalates in toys.
An approach based on migration limits requires testing methods to ensure compliance.
However, the testing methods developed have, in a review by the SCTEE, not been found
sufficiently good for regulatory purposes (opinion of 28 September 1999) which means that
the approach based on migration limits is not possible at this time. The present proposal
adopts the approach of a ban and stipulates that certain phthalates may not be used in toys and
child care articles intended to be put in the mouth by children under the age of three.
Furthermore, it is not allowed to place such products on the market if they contain certain
phthalates. Other toys of soft PVC intended for children under the age of three and which
could be put in the mouth, should bear a label alerting the caretakers to ensure that the
children are not putting them in the mouth. This ban approach should provide a high level of
safety to small children.

As the adoption and implementation of the proposed ban on phthalates under Directive
76/769 will, due to the decision-making arrangements applicable, take a certain period, it is
also necessary, given the character of the risk, to ensure a consistent high level of child health
protection during the period preceding this implementation. Therefore the Commission is
simultaneously to agree a Commission Decision under Article 9 of the Directive on Product
Safety 92/59/EEC requiring Member States to take temporary measures to implement the
prohibition foreseen in the proposal under Directive 76/769 within less than 10 days.

1

OJ L 228, 11.8.1992, p. 24.

2

However, the market situation must be continually monitored to ensure that any alternative
products or substitute plasticisers do not introduce new health dangers. Member States will
perform this monitoring and inform the Commission which will produce a report within three
years of adoption of this Directive. The report will, together with other scientific information,
serve as a basis for reviewing this Directive within four years of adoption and for considering
possible restrictions on other substances.

2.

JUSTIFICATION FOR PROPOSAL AND CONSIDERATIONS OF
SUBSIDIARITY

What are the objectives of the proposal in relation to the Community’s obligations ?

The objective of the proposal is to introduce harmonised provisions with regard to phthalates
in toys and child care articles and thus preserving the Internal Market, as required by Article
95 of the Treaty. The objective is also, as set out in Article 95.3, Article 152.1 and 153.2 of
the Treaty, to ensure a high level of health protection and of consumer protection, notably of
young children.

Does the initiatives arise out of an exclusive Community competence or a shared
competence?

The action to preserve the Internal Market for dangerous substances falls within the exclusive
competence of the Community. This competence was established by Council Directive
76/769/EEC.

What are the courses of action available to the Community ?

The only course of action available that can provide a permanent solution is a proposal for an
amendment
the twenty-second amendment, providing for
harmonised rules on the marketing and use of phthalates in toys and child care articles2.

to Directive 76/769/EEC,

Are uniform rules necessary ? Is it not sufficient to establish targets to be implemented by
Member States ?

The proposed 22nd amendment establishes uniform rules for the marketing and use of
phthalates in toys and child care articles. It also guarantees a high level of protection of health
and safety of consumers. The proposed 22nd amendment is the only way to meet these goals.
Targets would be insufficient.

3.

RATIONALE OF THE PROPOSAL

Phthalates may pose a risk when used in soft PVC toys and child care articles put in the
mouth by small children. The proposed 22nd amendment would prohibit the placing on the
market of toys and child care articles intended to be put in the mouth by children under the
age of three and containing phthalates. Furthermore, other toys of soft PVC intended for
children under the age of three and which could be put in the mouth should bear a label
alerting those caring for the children that the toys and child care articles are not to be put in
the mouth.

2

The solution for the transitional period pending application of this proposal is a phthalates ban under the
General Product Safety Directive.

3

4.

COSTS AND BENEFITS

4.1.

Costs

A majority of Member States has introduced or notified their intention to introduce, in the
framework of Commission Recommendation 98/485/EC, national bans, with various scopes,
on the use of phthalates in toys. The Recommendation urges Member States to adopt the
measures required to ensure a high level of health protection for children in regard to toys and
child care articles made of soft PVC containing certain phthalates and intended to be put in
the mouth by children of less than three years of age. The industry has adapted to this
situation and, at least in a majority of Member States, most of the products in question no
longer contain phthalates which means that the costs are likely to be limited.

4.2.

Benefits

A benefit of the proposal is to protect the health of children. The proposed ban will ensure
that no toys and child care articles containing phthalates are placed on the market if intended
to be put in the mouth by children under the age of three. A second benefit is that the
proposed Directive will provide harmonised provisions throughout the Community thus
establishing an Internal Market in this field.

5.

PROPORTIONALITY

The 22nd amendment would yield benefits in terms of protecting the health of children. This
would be achieved at low costs.

6.

CONSULTATIONS PERFORMED IN RPEPARING THE DRAFT 22nd
AMENDMENT

Advice on the preparation of the proposal was sought from experts from Member States,
industry,
toys), and NGOs
(environmental and consumer organisations) through meetings and a written procedure.

(including manufacturers of chemicals, of PVC and of

7.

CONFORMITY WITH THE TREATY

This proposal is intended to facilitate a high level of protection of health of the consumers and
is therefore in conformity with Article 95.3, 152.1 and 153.2 of the Treaty.

The proposal does not call for any special provisions of the kind referred to in Article 15 of
the Treaty.

It is in conformity with Article 5.

8.

CONSULTATION OF THE EUROPEAN PARLIAMENT AND THE
ECONOMIC AND SOCIAL COMMITTEE

In compliance with Article 95 of the Treaty, the Co-decision Procedure with the European
Parliament is applicable. The Economic and Social Committee has to be consulted.

4

1999/0238 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending for the 22nd time 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)
and amending Council Directive 88/378/EEC on the approximation of the laws of the
Member States concerning the safety of toys

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular
Article 95 thereof,

Having regard to the proposal from the Commission3,

Having regard to the opinion of the Economic and Social Committee4,

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

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 and the measures proposed by this Directive comply with the
requirements that a high level of health protection and of consumer protection shall be
ensured in the definition and implementation of all Community policies and activities.

(3)

(4)

(5)

The presence of phthalates in certain toys and childcare articles made of soft PVC and
intended to be placed in the mouth, presents risks related to general toxicity to the
health of young children.

The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE),
after being consulted by the Commission, has delivered two opinions on these health
risks.

The Commission Recommendation 98/485/EC 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

3

4

OJ
OJ

5

(6)

(7)

(8)

(9)

containing certain phthalates5 invites Member States to take measures required to
ensure a high level of child health protection in regards to these products.

Limitations already adopted or planned by certain Member States on the marketing of
the
toys and childcare articles because of their phthalate content directly affect
completion and functioning of the internal market and it is therefore necessary to
approximate the laws of the Member States in this field and consequently to amend
Annex 1 to Directive 76/769/EEC6.

It is necessary to provide for adequate labeling for child care articles made of soft
PVC or including parts made of soft PVC intended for children under the age of three,
which, although not intended for that purpose, can be put in the mouth. Such labeling
also has to be provided for in Directive 88/378/EEC of 3 May 1988 on the
approximation of the laws of the Member States concerning the safety of toys7 for
those toys, which fall within the scope of that Directive.

The Commission will review the provisions in this Directive in the light of further
scientific knowledge within four years of adoption.

for

This Directive does not affect Community legislation laying down minimum
the protection of workers contained in Council Directive
requirements
89/391/EEC8 and in individual directives based thereon,
in particular Council
Directive 90/394/EEC9 and Council Directive 98/24/EC10 on protection of health and
safety of workers from the risk related to chemical agents at work.

HAVE ADOPTED THIS DIRECTIVE:

Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex hereto.

Article 1

In Annex IV of Directive 88/378/EEC the following paragraph is added:

Article 2

“7. Toys, made of or including parts of soft PVC containing the phthalates listed
in point XX of the Annex to Directive 76/769/EEC, which are intended for
children under the age of three and which can be put in the mouth, although not
intended for that purpose

The following warning shall appear in an easily legible and indelible form on the
packaging for the toy.

5

6

7

8

9

10

OJ L 217, 5.8.1998, p. 35-37
OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 1999/77/EC,
OJ L 207, 6.8.1999, p. 18.
OJ L 187, 16.7.1988, p. 1. Directive as last amended by Council Directive 93/68/EEC, OJ L 220,
30.8.1993, p. 1.
OJ L 183, 29.06.1989, p. 1.
OJ L 196, 26.07.1990, p. 1.
OJ L 131, 5.5. 1998, p. 11

6

“Warning – do not put in the mouth for extended periods as could release phthalates
dangerous to child health”.

The following shorter warning shall appear in an easily legible and indelible form on
the toy:

“Not to be kept in the mouth”.

Article3

1.

2.

Member States shall adopt and publish the laws, regulations and administrative
provisions necessary to comply with this Directive no later than [six month] after the
date of its entry into force. They shall forthwith inform the Commission thereof.

They shall apply these provisions [one year] after entry into force of this Directive.

When Member States adopt those provisions, 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.

This Directive shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Communities.

Article 4

Article 5

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

7

The following point is added to Annex I to Directive 76/769/EEC:

ANNEX

XX

Phthalates

of the following types:

- di-“isononyl” phthalate (DINP)

CAS No 28553-12-0
EINECS No 249-079-5

- bis(2-ethylhexyl) phthalate (DEHP)

CAS No 117-81-7
EINECS No 204-211-0

- dioctyl phthalate (DNOP)

CAS No 117-84-0
EINECS No 204-214-7

- di-“isodecyl” phthalate (DIDP)

CAS No 26761-40-0
EINECS No 247-977-1

- benzyl butyl 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

1. May not be used as substances or as
constituents of preparations at concentrations
of greater than 0.1% in toys and child care
articles made of PVC, or including parts of
PVC, intended to be put in the mouth by
children under the age of three.

2. Products referred to in point 1 above may
not be placed on the market unless they
conform to the requirements stated.

3. The following warning shall appear in an
easily legible and indelible form on the
packaging for childcare articles, other than
those referred to in point 1 above, made of or
including parts of soft PVC containing one or
more of these phthalates, and intended for
children under the age of three and which can
be put in the mouth:

“Warning – do not put in mouth for extended
periods as could release phthalates dangerous
to child health”.

The following shorter warning shall appear in
an easily legible and indelible form on the
childcare article:

“Not to be kept in the mouth”.

8