Select Committee on European Scrutiny Fifteenth Report


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 baseArticle 95 EC; co-decision; QMV
Deposited in Parliament 21 December 2005
DepartmentTrade and Industry
Basis of consideration EM of 9 January 2006
Previous Committee Reports None, but see footnote 27
Discussed in CouncilNot applicable
Committee's assessmentPolitically important
Committee's decisionNot 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


 
previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2006
Prepared 30 January 2006