4 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
|
| Legal base
| Article 95EC; co-decision; QMV
|
| Document originated
| 12 June 2009
|
| Deposited in Parliament
| 19 June 2009
|
| Department
| Work and Pensions
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| Basis of consideration
| EM of 3 July 2009
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| Previous Committee Report
| None |
| To be discussed in Council
| No date set
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| Committee's assessment
| Politically important
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| Committee's decision
| Not cleared; further information awaited
|
Background
4.1 Biocidal products are used to destroy
harmful organisms by chemical or biological means, and their marketing
and use within the Community is regulated under Directive 98/8/EC.[11]
As with comparable measures for other products, such as pesticides,
this involves a two-stage process — the so-called "active
substances" which give biocidal products their properties
being approved by the Community (and included in the list of such
products in an Annex to the Directive, following action by the
Commission under the comitology process), whilst the authorisation
of the biocidal 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; and it includes provisions
governing the use (and confidentiality) of data supplied in support
of an application for approval, the use of such data for second
or subsequent applications, and rules relating to the classification,
packaging, labelling and advertisement of products.
4.2 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 can continue to apply their national
rules for authorising these products. However, a report[12]
by the Commission in October 2008 noted that the progress to date
had been slower than anticipated, and that there was therefore
a need for a further transitional period so that existing active
substances and biocidal products could remain on the market while
that process was completed. It was therefore accompanied by a
draft Directive[13] extending
the transitional period by three years.
The current proposal
4.3 In the light of consultations which
it has carried out since then, the Commission has now put forward
this proposal to replace Directive 98/8/EC by a Regulation, and
to take into account a number of criticisms of the present arrangements.
4.4 More specifically, it would make
changes in the following areas:
Scope of the measure
Under the current Directive, where a
biocidal product is used to protect an article within the Community,
only an authorised product may be used, whereas no such restrictions
apply where such treatment takes place outside the Community and
the article is then imported: the proposal would remove that loophole,
and also ensure that appropriate labelling conditions apply to
both Community and non-Community manufacturers. In addition, it
would clarify application to active substances generated in situ
and to biocidal products used in materials which come into contact
with food.
Product authorisation
Under the current system, all biocidal
products are authorised at Member State level, with the proviso
that an authorisation by one Member State can be recognised in
another. The new Regulation would make two changes — it
would strengthen the mutual recognition arrangement, and introduce
a centralised Community authorisation system for biocidal products
based on new active substances and low-risk products, allowing
them to be placed on the Community market without any need for
separate national authorisations or the mutual recognition process.
Data sharing
At present, a Member State is prevented
from using data submitted by a first applicant for the evaluation
of subsequent applications unless the first applicant agrees,
and, whilst applicants are encouraged to cooperate in compiling
the necessary data, sharing is not mandatory. Subject to suitable
compensation being provided, the current proposal would make mandatory
the sharing of data relating to vertebrate animal tests in order
to avoid the submission of multiple dossiers and to minimise animal
testing so far as possible.
Data requirements
The current Directive requires toxicity
and ecotoxicity studies to be undertaken for active substances,
and the same set of data must be submitted for all biocidal products.
Given that this may not always be necessary and that the cost
of these studies is high, the Commission says that it has resulted
in a tendency for existing active substances to be supported or
for the abandonment of substances where there is no prospect of
an economic return. It also considers that the costs are likely
to be particularly disproportionate where substances are considered
to be low-risk. This proposal would therefore enable the need
for certain data to be waived where it is not scientifically necessary,
and would at the same time aim to harmonise the basis on which
Member States grant waivers.
Fees
At present, each Member State is responsible
for deciding its own structure and level of fees, which has resulted
in significant inconsistencies, as well as fees which are seen
to be disproportionately high in the case of small and medium
sized enterprises. The proposal would enable the Commission to
establish rules for a harmonised fee structure, and to set out
the principles on which this will be based.
The Government's view
4.5 We have received from the Parliamentary
Under-Secretary of State at the Department for Work and Pensions
(Lord McKenzie of Luton) an Explanatory Memorandum of 3 July 2009.
He says that the Government fully supports the regulation of biocidal
products at a European level, and that there are no major policy
issues which would give it grounds to oppose outright the introduction
of this Regulation, which he describes 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.
In particular, he notes that by June 2009 only some 30 such substances
had been agreed for inclusion in the positive list, and that no
biocidal products had yet been authorised in Member States: and
he suggests that, even though the review programme has been extended
until 2014, that extended deadline may not be achievable. He also
observes that UK stakeholders, and particularly SMEs, have been
heavily critical of the current Directive, and have argued that
its requirements are onerously expensive, and that it is overly
complicated and disproportionate in relation to its overall benefits.
In particular, the costs of supporting an active substance through
the assessment process are high, due to the cost of data gathering/provision
and the fees levied by some Member States for assessing the data
package.
4.6 As regards specific aspects of the
proposal, the Minister comments that:
· the proposed use of a Regulation
is in line with the measures agreed in 2006 and 2008 respectively
for chemicals (REACH) and Classification, Labelling and Packaging,
as well as with recent developments on pesticides and cosmetics;
· the UK supports the retention
of the concept of assessing active substances at Community level
for inclusion in a positive list, and then authorising biocidal
products for the market; however, although it considers the areas
identified by the Commission for improvement are appropriate,
it believes that, in some cases, the changes do not go far enough
and that other options should be explored to improve the workability
of the system;
· it aims to examine the opportunity
for further simplification and streamlining of the requirements,
and to question in particular the proposal to extend the scope
of biocides regulation to treated materials (where it is concerned
that the high cost to industry of assessing the additional active
substances and authorising additional products may outweigh the
current disadvantage to Community manufacturers from imported
materials containing biocides not authorised in the Community);
· practical, workable arrangements
for migrating from the present Directive to the new directly effective
Regulation are essential.
4.7 The Minister has also provided an
initial Impact Assessment, which forms the basis of the Government's
consultation with UK stakeholders, and which will be updated in
the light of the responses received. In the meantime, the Assessment
suggests that, on the basis of the figures produced by the Commission,
the total cost to the UK could give rise to a cost of between
£27.3 and £99.7 million over 10 years, with corresponding
benefits of between £318.2 and £804.9 million. However,
he also points out that the Commission accepts that the benefits
are likely to be towards the lower end of this range, and that
even these are unlikely to be realised fully in practice.
Conclusion
4.8 We note the Government's support
for the regulation of biocidal products at a European level, and
that it has no major problems over the amendments now proposed.
Equally, we note that it is in the process of consulting interested
parties within the UK on the basis of the initial Impact Assessment
provided by the Minister, and that, insofar as the figures in
that Assessment are based upon the one carried out by the Commission,
the Government intends to produce its own assessment of the costs
and benefits in the light of the responses to its consultation.
Consequently, we think it right to await that Assessment before
considering the proposal further, but we are in the meantime drawing
it to the attention of the House.
11 OJ No. L 123, 24.4.98, p.1. Back
12
(30029) 14027/08. Back
13
(30028) 14024/08. Back
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