Memorandum by the Department of the Environment,
Transport and the Regions
2001 (S.I. 2001/880)
1. The Committee has asked for a memorandum on the
"(1) Explain how regulation
8 fully implements Article 3 of the Directive, given that that
regulation does not require a biocidal product containing an active
substance which is included in Annex 1B of the Directive to be
used in accordance with the conditions of use specified in the
label of that product."
2. Article 3(1) of the Directive provides that a
biocidal product shall not be placed on the market and used unless
it has been authorised in accordance with the Directive. Article
5 of the Directive contains provisions relating to the conditions
for the issue of an authorisation. Article 3.7 of the Directive
provides that proper use shall include compliance with conditions
established pursuant to Article 5 and specified under the labelling
provisions of the Directive. Article 3(2)(ii) of the Directive
contains a derogation from the provisions of Article 3(1) so that
member States shall allow the placing on the market and use of
active substances placed on Annex 1B.
(a) biocidal products
containing active substances which are on Annex 1B do not have
to be authorised;
(b) no conditions of
use established pursuant to Article 5 will apply to such biocidal
products because the products do not have to be authorised; and
(c) since there are no
such conditions, no label is required on such a biocidal product
under Article 3.
4. The Department therefore considers that Article
3 of the Directive has been fully implemented.
(2) Regulation 8(5) imposes
a duty on all users of the relevant biocidal product. Given that
failure to comply with this duty is an offence (Schedule 11),
explain how a person subject to the duty can be expected to establish,
with sufficient certainty to avoid criminal liability, if he is
using a product in a manner "which involves the rational
application of a combination of physical, biological, chemical
or other measures" or that such measures are "appropriate
to limit the use of biocidal products to the minimum necessary
for the effective control of target organisms"."
5. Where guidance is given by the manufacturer of
the biocidal product in question on the amount which should be
used , it is expected that a person who uses the biocidal product
will follow that guidance.
6. If a person is in any doubt about the use of the
biocidal product he should seek appropriate advice as to its use.
7. The Committee will of course be aware that the
UK is under an obligation to implement the provisions of the Directive
and, where appropriate, include provisions enabling such obligations
to be enforced. In this case, the relevant article in the Directive
is Article 3.7 which provides that "Member States shall prescribe
that biocidal products are to be properly used." The article
then goes on to explain what is meant by "properly used",
which explanation includes the words which the Committee has referred
8. Finally, the Department is working with industry
with a view to producing guidance on this issue.
(3) Regulation 19(11) provides
that the Ministers may revoke an authorisation granted under regulation
17 if the experiment or test in question is liable to have harmful
effects on human or animal health or an unacceptable adverse effect
on the environment. Explain the sort of circumstances in which
it is contemplated that the Ministers may exercise their discretion
not to revoke the authorisation, and why (unlike the preceding
paragraphs in regulation 19) this provision confers a discretion
on the Ministers whether or not to revoke the authorisation.
9. The use of biocides is always subject to a risk
benefit assessment. The use of a biocide may affect organisms
which it is not intended to target as well as those which are
the intended targets or may adversely affect the environment.
The Ministers would need to weigh the risks to the organisms which
it is not intended to target or the environment against the need
to have a biocide to deal with target organisms. In some cases
the need to have the biocide may outweigh the risks to the organisms
it is not intended to target or the environment. Consequently,
it was considered that, in the case of a revocation of an authorisation
granted pursuant to regulation 17, it would be appropriate for
the Ministers to have a discretion.
10. For example, testing a new rodenticide may involve
risks to birds of prey. In this case, the Ministers would need
to weigh the risk to the birds against the need for the new rodenticide
(or even the knowledge that the product is available and would
be effective if it were needed). Consequently, it is considered
that the Ministers should have a discretion, rather than a duty,
to revoke in order to enable the test to continue if they consider
that the need to have the biocidal product prevails over the risks
to the birds of prey.
"(4) Regulation 25(6)
requires the authorisation holder and the new applicant to take
all reasonable steps to reach agreement on the sharing of information
in order to avoid, if possible, the duplication of testing on
vertebrate animals. Given the imprecise nature of this obligation,
explain why failure to comply with it has been made a criminal
offence (Schedule 11), and how it can be determined whether this
provision has been contravened."
11. Article 13(2) of the Directive requires the holder
of an authorisation and a new applicant to take all reasonable
steps to reach agreement on the sharing of information to avoid
if possible the duplication of testing vertebrate animals.
12. Further it is the Department's policy that people
should share data on experiments on animals. It is therefore considered
that making the failure to comply with the provision a criminal
offence is the appropriate sanction for the enforcement of the
obligation contained in the Directive and to achieve the policy
13. Evidence of failure to comply with the provision
(a) the lack of any
attempt by the new applicant to contact the authorisation holder;
(b) the failure of the
authorisation holder to respond positively to a request for information
from a new applicant.
14. Evidence that the provision has been complied
with might be gained from correspondence between the parties involved
and minutes of meetings.
"(5) Paragraph 3 of
Schedule 11 provides that a failure to discharge a duty (a) placed
on the Ministers by these Regulations, or (b) placed on any person
by the regulations specified, including 9(8) and 10(9), shall
not be an offence. Explain why regulations 9(8) and 10(9) have
been included in (b), given that they only impose a duty on the
Ministers and are therefore covered by (a). Are those provisions
intended to impose a duty on the applicant to provide the additional
information requested by the Ministers? If so, why is no express
provision made to this effect?"
15. It is thought that regulation 9(8) and 10(9)
could be interpreted as implying the placing of a duty on the
applicant when asked by the Ministers to provide additional information.
However, it is desired that failure to comply with any such duty
as may exist should not be a criminal offence. Therefore, to put
the matter beyond doubt, a reference to regulations 9(8) and 10(9)
was included in paragraph 3(b) of Schedule 11.
8 May 2001