10 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 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
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| Legal base | Article 95 EC; co-decision; QMV
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| Department | Trade and Industry
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| Basis of consideration | Minister's letter of 20 September 2004
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| Previous Committee Report | HC 23-vi (1999-2000), para 2 (26 January 2000) and HC 23-xx (1999-2000), para 5 (7 June 2000)
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| Discussed in Council | 24 September 2004
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
10.1 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 put in the mouth, in
that risks could arise from six phthalates[18]
used in these circumstances, including two in particular di-isononyl
phthalate (DNIP) and bis (2-ethylhexyl) phthalate (DEHP).[19]
10.2 It was initially thought that these dangers
could be averted by establishing migration limits to ensure any
leaching from toys or childcare articles did not exceed the scientifically
established tolerable daily intake, but ensuring compliance would
have required a suitable testing procedure, which was not available.
The Commission therefore proposed in November 1999 a ban on the
use of the six phthalates in toys and childcare articles intended
to be put in the mouths of children under the age of three, whilst
their use in toys of soft PVC which could be put in the
mouth would have required a warning label.
10.3 As our predecessors noted in their Report of
26 January 2000, the UK believed that there was unlikely to be
any health risk for children from the majority of phthalates provided
exposure was kept low, but, since the UK industry had stopped
using five of the six covered by the proposed ban, the Government
accepted this approach. However, it shared the wider concern
about DEHP, and wished to see a Community-wide ban on its use
in toys and childcare articles intended to be put in the mouth.
Its main outstanding concern related to the labelling proposal,
in that, although the hazards from the products subject to it
were very much smaller than for those covered by the ban, it considered
that the labelling proposed could 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.
10.4 Our predecessors subsequently noted that, as
a result of discussions in Brussels, it seemed very unlikely that
the proposal as described would be adopted, since Member States
were almost evenly split between those which (like the UK) felt
the proposal went too far and those which believed that only a
wholesale ban would be sufficient. Our predecessors also expressed
concern about the difficulties which had arisen on the proposal,
as they believed it would be right for the Community to take some
action in this area, particularly in the case of DEHP. Consequently,
they said that they would welcome a further indication from the
Minister of what was now likely to happen in the light of a progress
report which was being made to the Council.
Minister's letter of 20 September 2004
10.5 Since then, neither our predecessors nor we
had heard from the Government until we received a letter of 20
September 2004 from the Secretary of State for Trade and Industry
(Ms Patricia Hewitt) providing a belated update. She tells us
that there have been ongoing discussions between Member States,
but that, whilst several revisions of the proposal have appeared,
they never reached the point where the Government felt that they
could be taken forward with us, and indeed they were subsequently
withdrawn. However, she says that the Presidency would be pressing
for political agreement on 24 September at the Competitiveness
Council on the text of a comprehensive proposal which it had first
submitted to COREPER on 27 July.[20]
10.6 In enclosing with her letter a copy of that
text, the Minister says that, in the period since the original
proposal was put forward, new risk assessments on phthalates have
become available, and that the health issues regarding their use
are now more clear-cut. Consequently, DEHP, DBP and BBP have been
identified as reprotoxic and classified accordingly (with a prohibition
on their use applying to all toys, whether or not they are intended
to be put in the mouth), whereas the information on DINP, DIDP
and DNOP is still inconclusive, and, pending further risk assessments,
the restrictions proposed on them are thus less severe (applying
only to toys intended for children under three years of age and
which can be put in the mouth). Also, the earlier labelling provisions
for toys which could be put in the mouth appear to have been dropped.
10.7 The Minister suggests that, in the light of
this evidence and the time which has elapsed, the continuation
of a temporary ban would be unsatisfactory, and she says that
the Government has consulted UK industry contacts, who agree with
that view. On that basis, the Government supports the Presidency's
proposal, which it believes provides a good basis for a workable
solution. That said, the Minister expresses regret that the latest
text was not brought to our attention early enough to provide
us with an opportunity to clear it before it was taken in the
Council, but she points out that her officials were concerned
that the text presented on 27 July would be subject to further
change, as with previous drafts, before a final version was presented
to COREPER. However, in recognising that the approach followed
is inconsistent with the principles of scrutiny, she also says
that she thinks it reasonable to vote for the proposal on this
occasion, as it is in the UK's interest to resolve this issue
with a permanent Directive.
Conclusion
10.8 We note, and share, the Minister's regret
that we did not see this latest text sufficiently soon to enable
us to take a view before it was agreed in the Council. Indeed,
we regret also the gap of over four years during which nothing
was heard from her Department on this proposal, a lapse for which
we do not find her explanation particularly convincing.
10.9 Having said that, we have noted that the
text — which we have been told has now been agreed by the
Council — amends the earlier proposal somewhat in order
to reflect more recent risk assessments, and that it was supported
by the UK. In the circumstances, we are now prepared to clear
the document.
18 Di-isononyl phthalate (DNIP), bis (2-ethylhexyl)
phthalate (DEHP), dioctyl phthalate (DNOP), di-"isodecyl"
phthalate (DIDP), benzyl butyl phthalate (BBP) and dibutyl phthalate
(DBP). Back
19
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.
Back
20
We have since been told that the Presidency text was agreed on
24 September. Back
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