Joint Committee on Statutory Instruments Third Report


Memorandum by the Department of the Environment, Transport and the Regions


1. The Committee has asked for a memorandum on the following points:

    "(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.

3. Therefore—

      (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 to.

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 requirement.

13. Evidence of failure to comply with the provision might include:

      (a)  the lack of any attempt by the new applicant to contact the authorisation holder; and

      (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

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