8 USE OF PHTHALATES IN TOYS
(27127)
PE CONS 3645/1/05 REV1
—
| 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)
|
| Legal base | Article 95 EC; co-decision; QMV
|
| Deposited in Parliament |
21 December 2005 |
| Department | Trade and Industry
|
| Basis of consideration |
EM of 9 January 2006 |
| Previous Committee Reports
| None, but see footnote 27 |
| Discussed in Council | Not applicable
|
| Committee's assessment | Politically important
|
| Committee's decision | Not cleared
|
Background
8.1 Phthalates are plasticisers which have been used for over
40 years to soften PVC, and are used in a wide range of products.
Concern had, however, been expressed over their use in toys and
childcare articles intended to be put in the mouth, since it was
considered that risks could arise from six phthalates[25]
used in these circumstances, including two in particular —
di-"isononyl" phthalate (DNIP) and bis (2-ethylhexyl)
phthalate (DEHP).[26]
8.2 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[27]
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. It has
also sought to apply since 1999 a series of temporary bans, using
its own powers, which the toy industry in the UK has operated
on a temporary basis.
8.3 A previous Committee noted on 26 January 2000
that, although the Government shared the wider concern about DEHP,
it believed there was unlikely to be any health risk for children
from the majority of phthalates so long as exposure was kept low,
but was prepared to accept the proposal in the light of the approach
adopted by the UK industry. However, it did have an outstanding
concern over the labelling proposal, which it considered 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
was known). It therefore intended to explore whether this requirement
could be amended to reflect more appropriately what it saw as
the very low level of risk involved.
8.4 Since Member States were almost evenly split
between as to the merits of the proposal, it seemed very unlikely
that it would be adopted as drafted, and the Government was therefore
asked in June 2000 for a further indication of what was now likely
to happen. In the event, no such indication was given until our
predecessors received a letter of 20 September 2004 from the then
Secretary of State for Trade and Industry. This said that there
had been ongoing discussions between Member States, but that these
had never reached the point where the Government felt they could
be taken forward. However, an attempt was being made to reach
political agreement at the Competitiveness Council on 24 September
2004 on a text which reflected new risk assessments showing that
DEHP, DBP and BBP had 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).
On the other hand, the information on DINP, DIDP and DNOP was
still inconclusive, and, pending further risk assessments, the
restrictions proposed on them would thus be 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 appeared to
have been dropped.
8.5 Since the Government supported the text in question,
which it believed provided a good basis for a workable solution,
our predecessors decided on 20 October 2004 to clear the proposal
on the basis of a further Report to the House.
Minister's letters of 4 August 2005, 8 November
2005 and 29 November 2005
8.6 We ourselves have since received three letters
from the Minister for Consumer Affairs at the Department of Trade
and Industry (Mr Gerry Sutcliffe). The first (on 4 August 2005)
made no reference to the developments in 2004, but said, following
the European Parliament's second reading vote, a revised text
was expected, and was likely to contain changes significant enough
to warrant a new Explanatory Memorandum, whilst the second (on
8 November 2005) confirmed that the Council had reached political
agreement in October 2004, and reiterated his earlier undertaking
to supply an Explanatory Memorandum on the revised text, which
we were told was expected shortly. However, the Minister then
wrote to us on 29 November 2005 to say that the matter had now
been agreed in COREPER, and that, as the new text had still not
been issued, it had not been possible to provide the promised
Explanatory Memorandum. He also said that the proposed restriction
on phthalates had been broadened, and that this was likely to
have a significant impact on the toys industry. In expressing
our incredulity at this turn of events, we also decided at our
meeting on 14 December 2005 to take up the Minister's offer to
provide an Explanatory Memorandum on the revised text.
The current document
8.7 The effect of the text now available —
which has been agreed as a result of the conciliation process,
and which we understand is to be published in the Official Journal
shortly —
is to impose a total ban on all toys containing more than 0.1%
by mass of DEHP, DBP and BBP, irrespective of whether they can
be put in the mouth, and to impose a similar ban in the case of
DINP, DIDP and DNOP for toys which could be put in the
mouth, irrespective of the age of the child. These provisions
would within four years be subject to a review, and amendment
if necessary, in the light of any new scientific evidence.
Explanatory Memorandum of 9 January 2006
8.8 We have now received from the Minister of State
for Industry and the Regions at the Department of Trade and Industry
(Alun Michael) an Explanatory Memorandum of 9 January 2006 enclosing
a partial Regulatory Impact Assessment, pointing out that what
has now been agreed goes further than the original proposal, or
the Common Position taken by the Council in 2004, in that, for
three of the phthalates concerned, restrictions would now be placed
on their use in toys which merely could be put in the mouth. He
points out that, according to the industry, substitute ingredients
used in toys cost on average 40% more than phthalates, but that
much will depend upon the guidance document which is being prepared
specifying what is to be considered as a toy which can be placed
in the mouth. He adds that, in view of this, any forecasts of
the financial implications of the Directive would at present be
speculative.
Conclusion
8.9 In our view, the Department's handling of
the scrutiny of this document and its predecessor —
ranging from the absence
in the earlier case of any indication of progress between 2000
and 2004, to the repeated failure more recently to provide the
promised Explanatory Memorandum —
has been lamentable. Furthermore, whatever the justification for
the measure now adopted in consumer protection terms, it is clear
that its impact remains uncertain, and will presumably do so unless
and until the further guidance referred to by the Minister becomes
available.
8.10 In the circumstances, we think it right at
this stage to draw the various scrutiny lapses to the attention
of the House, but to withhold clearance of the current document
pending further clarification of its financial impact.
25 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
26
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
27
(20750) 13308/99; see HC 23-vi (1999-2000), para 2 (26 January
2000), HC 23-xx (1999-2000), para 5 (7 June 2000) and HC 42-xxxiii
(2003-04), para 10 (20 October 2004). Back
|
