USE OF PHTHALATES IN TOYS
(20750)
13308/99
COM(99) 577
| Draft Directive amending for the 22nd time Directive 76/769/EEC on the
approximation of the laws, regulations and administrative procedures 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.
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| Legal base:
| Article 95 EC; co-decision; qualified majority voting
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| Department: |
Trade and Industry |
| Basis of consideration:
| Minister's letters of 6 March, 27 March and 23 May 2000
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| Previous Committee Report:
| HC 23-vi (1999-2000), paragraph 2 (26 January 2000)
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| Discussed in Council:
| 25 May 2000 |
| Committee's assessment:
| Politically important |
| Committee's decision:
| Not cleared; further information requested
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Background
5.1 Phthalates are plasticisers which have been
used for over 40 years to soften PVC, and are used in a wide range
of products. Concern has, however, arisen more recently over their
use in toys and childcare articles intended to be mouthed, in
that risks could arise from six phthalates used in these circumstances,
including two in particular — di-"isononyl" phthalate
(DNIP) and bis (2-ethylhexyl) phthalate (DEHP). In the case of
DNIP, there is no direct evidence of harm to human health, though
laboratory rats exposed to very high doses have developed liver
and kidney disorders, including liver tumours; DEHP, however,
causes adverse effects on the reproductive system of male rats
at relatively low exposure levels, and the mechanisms by which
these toxic effects come about are unknown.
5.2 It was initially thought that these dangers
could be averted by establishing migration limits to ensure any
leaching from toys or child care articles did not exceed the scientifically
established tolerable daily intake, but ensuring compliance would
require a suitable testing procedure, which is not yet available.
The Commission has, therefore, proposed a ban on the use of the
six potentially dangerous phthalates in toys and childcare articles
intended to be put in the mouths of children under the
age of three, whilst other toys of soft PVC which could
be put in the mouth would have to bear a warning label.
5.3 As we noted in our Report of 26 January 2000,
the UK believes that there is unlikely to be any health risk for
children from the majority of phthalates provided exposure is
kept low, but, since the UK industry has stopped using five of
the six covered by the proposed ban, the Government has accepted
this approach. However, it shares the wider concern about DEHP,
and would wish to see a Community-wide ban on its use in toys
and childcare articles intended to be mouthed. Its main outstanding
concern relates to the labelling proposal in that, although the
hazards from the products subject to it are very much smaller
than for those covered by the ban, it considers that the labelling
proposed can be expected to have virtually the same effect as
a ban (and would also involve the use of substitutes about whose
safety even less is known). The Government therefore intended
to explore in discussion whether the labelling requirement could
be amended to reflect more appropriately what it saw as the very
low level of risk involved.
5.4 In our conclusion, we noted that it clearly
made sense for the Community to take action to ensure a uniform
approach commensurate with the possible risks to children's health,
particularly from DEHP, and that the Government supported a ban
on the use in products intended to be mouthed by children of the
six phthalates judged to carry a risk. We also noted its reservations
over the labelling proposed by the Commission for products which
could be put in the mouth. We said that we would be interested
to see the outcome of its planned consultation on the labelling
proposed, and of any discussions in Brussels over this requirement.
We added that, before considering clearance of the document, we
would also welcome further information on two points. First, whether
the proposed measures would apply to articles imported from outside
the Community. Secondly, although the Government had said that
it was concerned that the labelling requirement could lead to
the use of alternative plasticisers of unknown safety, it seemed
to us that, given the known risks from DEHP, it would in any case
be prudent to apply the labelling proposal to that particular
substance.
Minister's letters of 6 March, 27 March
and 23 May 2000
5.5 We have since received three letters on this
proposal from the Minister for Competition and Consumer Affairs
at the Department of Trade and Industry (Dr Howells), dated 6
March, 27 March and 23 May 2000. Taken together, the first two
of these confirm that the proposed measures would also apply to
articles imported from outside the Community, and that the UK
would support a labelling requirement for DEHP of the sort proposed,
subject to the proviso that, should another measure be identified
in the course of discussion which would have the same effect of
ensuring that small children did not put DEHP-containing toys
or articles in their mouths, the Government would support it.
5.6 In his most recent letter, the Minister first
summarises the outcome of the consultation exercise carried out
by his Department, although only 24 out of the 348 organisations
to whom the proposal was sent actually responded. He says that
there appeared to be two main areas of concern — the difficulty
seen by manufacturers (including those in other areas where softened
PVC is used more extensively), who believed the proposal to be
unjustified and likely to lead to the use of more expensive, less
effective and less well researched substitutes, and the problem
foreseen by retailers in communicating a meaningful message to
consumers through labelling. Consumer groups were broadly in favour,
though one wanted the labelling requirement dropped, and another
suggested extending it to all toys for children under six.
5.7 The Minister also said that, as a result
of discussions in Brussels, it looks very unlikely that the proposal
as described will be adopted, since Member States are almost evenly
split between those who (like the UK) feel the proposal goes too
far and those who believe only a wholesale ban is sufficient.
He says that a similar division exists over a revised compromise
produced recently by the Portuguese Presidency, and that a progress
report was to be presented to the Internal Market Council on 25
May.
Conclusion
5.8 We are grateful to the Minister for his
various letters, which deal satisfactorily with the points which
we raised in our earlier Report. We were, however, concerned to
learn of the difficulties which have since arisen on the proposal,
as we believe it would be right for the Community to take some
action in this area, particularly in the case of DEHP. We note
that a progress report was to be presented to the Council on 25
May, and, in the light of this, we would welcome a further indication
from the Minister of what is now likely to happen. In the
meantime, we are again withholding clearance.
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