Opinion of the Economic and Social Committee on the '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: 2000-03-01
Institutions: European Economic and Social Committee
Subjects: chemical product, child, labelling, product safety, public health, toy industry

26.4.2000

EN

Official Journal of the European Communities

C 117/59

Opinion of the Economic and Social Committee on the ‘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’

(2000/C 117/12)

On 29 February 2000, the Council decided to consult the Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing
the Committee’s work on the subject, adopted its opinion on 15 February 2000. The rapporteur was Mrs
Williams.

At its 370th plenary session on 1 and 2 March 2000 (meeting of 1 March), the Economic and Social
Committee adopted the following opinion by 27 votes to twenty-one, with eight abstentions.

1.

Introduction

1.1.
First and foremost, the present proposal relates to the
high level of protection of health and safety of consumers
endorsed in the EU Treaty and continuing now in the
Amsterdam Treaty under Article 153. The Commission pro-
poses to ban the use of six toxic phthalates in certain products
for babies and small children — the weakest and most
vulnerable consumers. It sets out a twenty-second amendment
to the existing Directive on dangerous substances (1) and adds
a separate amendment to the Directive on toy safety (2).

Nevertheless, the proposal has wide-ranging general
1.2.
implications. It is concerned with the following major issues
or subjects:

The relevance of the precautionary principle in
1.2.5.1.
particular must be highlighted. This is a relatively new
procedure described in a recent Communication from the
Commission (4), and this is only the third time it has been
invoked. The procedure enables the Commission to take
preventive action where evidence is ‘insufficient, inconclusive
or uncertain’ but where failure to act would result in excessive
risk to public health or the environment (as in the case of
dioxins in Belgian food). The central principle is that when
there is a potential threat, risk assessment studies should be
carried out; nevertheless,
the results do not have to be
conclusive for action to be taken. ‘The absence of scientific
proof … should not be used to justify inaction.’

2. Background information

1.2.1.
the harmonisation of practices and the establishment
of uniform rules in both the Internal Market and the ‘candidate’
countries;

2.1. What are phthalates?

1.2.2.
the interaction with other Directives, such as the use
of emergency procedures outlined in Article 9 of the General
Product Safety Directive (GPSD) (3);

1.2.3.
level of release of phtalates;

the validity of test methods used to ascertain the

Six phthalates, itemised in an Annex, are the subject of the
present proposal. They are long established chemicals which
are added to hard plastic (like polyvinyl chloride — PVC) to
soften it. The softened plastic can then be used to make
products for babies and small children under thirty-six months
such as teething rings, dummies, rattles and some toys such as
bathtime ducks. The commonest phthalate in use for products
such as teethers has been di-‘isononyl’ phthalate (DINP). Some
phthalates can also occur naturally in foods such as bananas.

1.2.4.
bound to arouse emotion as well as practical considerations;

pressures from environmental groups on a subject

2.2. What are the problems with phthalates?

1.2.5.
and the use of the precautionary principle.

the growing emphasis on risk assessment procedures

Phthalates are not bound into the PVC and can over time
migrate or leach. Tests on rats show that phthalates can cause
hormonal disturbances as well as cancer with consequent
damage to liver, kidneys and testicles. The particular risk is to
babies and small children who chew and suck over prolonged

(1) Directive 76/769/EEC, OJ L 262, 27.9.1976, p. 201.
(2) Directive 88/378/EEC, OJ L 187, 16.7.1988, p. 1.
(3) Directive 92/59/EEC, OJ L 228, 11.8.1992, p. 24.

(4) COM(2000) 1 final of 2.2.2000.

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periods. Their chewing action can break down the plastic
which accelerates the release of phthalates and its consequent
migration into their saliva. Moreover, an Acceptable Daily
Intake (ADI) tolerable in an adult is not tolerable in a baby
because of its lower body weight. Phthalates may be cumulative
and can be absorbed by the baby from other sources e.g.
through breast milk.

Secondly, regarding future action,

3.2.
the Committee
questions the Commission’s procedure (outlined in Article 2)
for dealing with products which can be put in the mouth
although not intended for that purpose. The Commission
intends to deal with the risks inherent in such items —
predominantly toys where the length of sucking/chewing time
is less — via labelling which will provide warnings to parents
and other carers of small children.

2.2.1.
Therefore there has been a strong call from certain
Member States for a ban on phthalates in products for infants,
which resulted in a Recommendation in July 1998 (1) (rather
than the emergency ban Commissioner Bonino would have
wished). There has also been pressure from environmental
groups for a ban as part of a broader campaign for the removal
of all PVC products. The Scientific Committee on Toxicology,
Ecotoxicology and the Environment produced its Opinion in
Autumn 1999.

The Commission, through the emergency procedures
2.2.2.
in the GPSD, has received the agreement of Member States to
a temporary and interim ban of the six phthalates on the
grounds that they pose a serious risk to child health. This
measure came into effect on 19 December 1999.

2.2.3.
legislation in the longer term.

This present proposal deals with the amendment of

3. General Comments: the Committee’s view

First,

the Committee supports

3.1.
the Commission’s
immediate ban on phthalates in certain childcare products and
accordingly Article 1 of the proposed Directive.

Since the ban is an interim and temporary measure
3.1.1.
to be reviewed on 8 March, the Committee asks what future
transitional procedures are to be followed.

3.1.2.
The Committee realises that the Commission had
two choices: either to impose a ban or to rely on stringent
tests for maximum release limits against which checks could
be instituted. Since such test methods for phthalates are still
uncertain, unreliable and unable to be reproduced in view of
the difficulty in simulating the sucking and chewing action of
a baby, the Committee accepts the Commission’s decision
invoking the Precautionary Principle. Moreover, it points out
that alternatives which may be developed could present new
doubts and uncertainties and accordingly calls for much
further research.

(1) Recommendation 98/485/EC, OJ L 217, 5.8.1998, p. 35.

3.2.1.
The Committee emphasises the practical difficulties
in formulating any form of cautionary words which can
reasonably cover the huge range of children’s products
involved, particularly if such words have to appear on the
product as well as on the packaging in several languages.

4. Specific comments

4.1. Article 1

The Committee accepts this Article as the only possibility
under present circumstances with the general reservations
already expressed. There are the following additional points to
be raised:

4.1.1.
The Committee regrets that the final amendment to
the legislation on the marketing of dangerous products can
only be applied several years from now ‘for procedural reasons’
but notes that the bridging mechanisms to be put in place
must continue to ensure the safety of babies and young
children.

4.1.2.
The Committee points out the particular problem of
controlling the supply of items handed down in families and
used by children in different age groups. It also notes the
problem of childcare products sold second hand (e.g. in charity
shops).

4.1.3.
The Committee stresses the importance of enforce-
ment (with Europe-wide co-ordination) by responsible auth-
orities, bearing in mind the problems of those countries where
there is not always a single authority.

4.1.4.
The Committee emphasises the need for constant
and effective monitoring of the ban, with special market
surveillance for products imported from third and third-world
countries.

4.1.5.
The Committee stresses the need for effective com-
munication with parents and all those responsible for childcare
on the subject of product safety in general and on phthalates
in particular, with special consideration given to the extension
of Helpline telephone numbers provided on packaging by
some manufacturers. It also calls for sensitive, non-authoritari-
an education, starting at an early age, relating to the care and
behaviour of babies and small children.

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4.2. Article 2

The Committee points out that the severity of these warnings
is such that they are effectively a ban. The suggested wording
of such labels, moreover, is difficult and fails to communicate
adequately.

Nevertheless, if such labelling is finally accepted as an appropri-
ate measure, then the Committee makes the following com-
ments.

4.2.1.
indelible. It must also be understandable.

It is not enough for any warning to be legible and

4.2.2.
The Committee questions the practicality — both in
design and manufacture — of applying permanent warning
labels to small items intended for children, particularly if a
range of languages is involved.

4.3.
Since the risk inherent in sucking or chewing a toy
intermittently is slight, then the Committee recommends for
the time being that the proposed cautionary labelling on actual

products should be dropped in the light of the difficulties it
would cause. Warnings should appear on packaging where
size permits. The precautionary principle invoked states that
measures based on the precautionary principle must be
proportionate to the risk which is to be limited or eliminated.

5. Conclusion

5.1.
The Committee reiterates the over-riding importance
of safety, particularly where children are concerned, and
supports the Commission’s efforts in introducing the current
ban. It remains concerned, however, that the validity of present
test methods to ascertain the level of release of phthalates is
still uncertain, and that alternative materials provide new
doubts. It accordingly calls for much further research.

The Committee accepts that

5.2.
the Commission in
Article 2 is indicating its belief in parents’ right to information
by providing stringent warnings on both packaging and actual
childcare items. If the Commission persists in enforcing these
warnings, both their language and practicality of communi-
cation must be taken into account.

Brussels, 1 March 2000.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI