14 Marketing and use of biocidal products
(30702)
11063/09
+ ADDs 1-2
COM(09) 267
| Draft Regulation concerning the placing on the market and use of biocidal products
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Legal base | Article 95 EC; co-decision; QMV
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Department | Work and Pensions
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Basis of consideration | Minister's letters of 13 October 2010 and 2 December 2010
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Previous Committee Report | HC 19-xxiv (2008-09), chapter 4 (15 July 2009)
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To be discussed in Council | 20 December 2010
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Committee's assessment | Politically important
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Committee's decision | Cleared
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Background
14.1 Biocidal products are used to destroy harmful organisms,
and their marketing within the EU is regulated under Directive
98/8/EC.[67] This involves
a two-stage process the so-called "active substances",
which give biocidal products their properties, being approved
by the EU (and listed in an Annex to the Directive), whilst the
authorisation of the products themselves is in the hands of Member
States, with provision being made for a product approved in one
Member State to be used in another. The Directive contains a simplified
procedure for approving low-risk products, as well as provisions
governing the use (and confidentiality) of data supplied in support
of an application for approval, and rules relating to the classification,
packaging, labelling and advertisement of products.
14.2 The Directive also provides that active substances
on the market when it came into force should be reviewed to ensure
they can still be used, and individual products containing them
would then have to be authorised. This review programme was originally
expected to last 10 years, and the Directive therefore contained
a transitional period (until 14 May 2010) during which Member
States could continue to apply their national rules for authorising
these products. However, as progress turned out to be slower than
anticipated, the transitional period was extended by three years.
14.3 In the meantime, the Commission put forward
in June 2009 this proposal to replace Directive 98/8/EC by a Regulation,
and to take into account a number of criticisms of the present
arrangements. More specifically, as our predecessors noted in
their Report of 15 July 2009, it suggested changes which would
extend the scope of the measure to imported products; strengthen
the mutual recognition of products authorised by a Member State;
introduce a centralised EU authorisation system; strengthen the
provisions relating to data sharing; enable the need for certain
data to be waived where this is not scientifically necessary;
and enable the Commission to establish rules for a harmonised
fee structure.
14.4 The then Government said that it fully supported
the regulation of biocidal products at a European level, and that
there were no major policy issues which would give it grounds
to oppose outright the introduction of this Regulation, which
it described as urgently needed in the light of the very slow
progress made so far in the 10 year programme envisaged in Directive
98/8/EC for reviewing existing active substances. It also observed
that UK stakeholders, and particularly SMEs, had been heavily
critical of the current Directive, and had argued that its requirements
are both onerously expensive and overly complicated and disproportionate
in relation to the overall benefits. In particular, the costs
of supporting an active substance through the assessment process
are high, due to the need to provide data and the fees levied
by some Member States for assessing this. The then Government
also provided an initial Impact Assessment, which formed the basis
of its consultation with UK stakeholders, and which it said would
be updated in the light of the responses received.
14.5 In noting the UK's support for the regulation
of biocidal products at a European level, our predecessors also
said that, since the then Government intended to produce a further
assessment of the costs and benefits, they would draw the proposal
to the attention of the House, but await that assessment before
considering it further.
Minister's letter of 13 October 2010
14.6 We received from the current Minister for Employment
at the Department for Work and Pensions (Rt Hon Chris Grayling)
a letter of 13 October 2010 providing an update on the negotiations.
He said that the Belgian Presidency was aiming to achieve political
agreement in December, and that he would write to us again prior
to that, when he would request scrutiny clearance.
14.7 In the meantime, the Minister said that the
UK had put forward numerous drafting suggestions, many of which
had been incorporated into the latest draft text, its focus having
been on the need to streamline the authorisation process, without
compromising protection of human health and the environment. He
added that, although the overall picture was somewhat mixed, with
some Member States favouring tighter controls, the direction of
negotiations has been broadly positive so far as the UK's more
pragmatic, risk-based approach was concerned. He also noted that
the European Parliament had shown a high level of interest, with
the plenary session having voted on a package of amendments, and
he identified the positive outcomes for the UK as including the
fact that (with a few exceptions) all biocidal product types would
be open to EU-wide authorisation after an initial transitional
period lasting until 2017; support for reduced testing on vertebrate
animals and the waiving of data requirements; and the defeat of
an amendment to increase the number of substances which are considered
candidates for substitution (which had the potential to further
restrict the biocidal substances allowed on the market).
14.8 However, he observed that there had also been
some less positive outcomes, including the inclusion of some potentially
burdensome additional administrative requirements, and some restrictive
provisions on the use of nanomaterials in biocidal products. He
summed up the overall position by suggesting that the picture
for UK was mixed, though with more positives than negatives on
the most important issues, and he noted that there had also been
signs of a convergence of views on several of the main issues,
leaving open the possibility of an agreement between the Council
and Parliament in the first half of 2011.
14.9 The Minister also attached to his letter a full
UK Impact Assessment, which identified savings from improved product
authorisation procedures and from provisions for data-sharing
and data-waiving, though with some increased costs as a result
of an increase in scope to cover treated articles and materials.
Overall, the assessment estimated that the Regulation proposed
would lead to an overall cost saving of between £135m and
£264m for UK industry over 10 years, but that these could
potentially be greater if UK was able to secure further streamlining
and simplification to the regime through drafting changes.
Minister's letter of 2 December 2010
14.10 We have now received from the Minister a further
letter of 2 December 2010, providing an update on the negotiations.
He says that the indications are that Member States are now converging
on an agreed text, on which the UK remains relatively well placed
in most respects. In particular, he says that there is a consensus
that active substances with certain health and environmental hazards
should be excluded from use in biocides, but that, in recognition
that inherently hazardous substances may be required for beneficial
purposes, derogations would be allowed where the exclusion of
a substance would have a disproportionately negative impact and
no suitable alternatives are available; that the UK favours giving
a wide scope to the EU-wide authorisation of certain products
to maximise the cost savings for businesses which market biocides
across the EU, and has resisted pressure from some other Member
States to narrow this provision; and that an agreed position is
now close on provisions for data-sharing and data-waiving and
the mutual recognition of authorisations.
14.11 The Minister concludes by asking us to release
the document from scrutiny in advance of the meeting of the Environment
Council on 20 December, when he says the Presidency is hoping
to achieve a common position.
Conclusion
14.12 We are grateful to the Minister for this
information, and, in the light of the progress in the negotiations
and the positive overall cost-benefit position revealed by the
full UK Impact Assessment, we are now content to clear the document.
67 OJ No. L 123, 24.4.98, p.1. Back
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