Royal Decree 1054/2002 of 11 October 2002 regulating the evaluation process for the registration, authorisation and placing on the market of biocidal products has transposed Directive 98 /8/EC of the European Parliament and of the European Parliament into national law. Council Decision of 16 February 1998 concerning the placing of biocidal products on the market. In Annexes I and IA to that Royal Decree, which coincide with those of the same number of the said Directive, they are entitled 'List of active substances for inclusion in biocidal products' and 'List of active substances for inclusion in low-level biocidal products'. 'risk', respectively, should be included in advance of the active substances which are to be part of a biocidal product or a low-risk biocidal product, in order to be able to register it in the Official Register of Biocidal Products and, where appropriate, to obtain the mutual recognition of registration in the other States of the European Union. As a result of the study and evaluation carried out at Community level, the Commission has approved the inclusion in Annexes I and IA of Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 of active substances difetialone and carbon dioxide, respectively, for use in biocidal products and low-risk biocidal products of the type of rodenticides. This has been done by means of Commission Directive 2007 /69/EC of 29 November 2007 amending Directive 98 /8/EC of the European Parliament and of the Council in order to include difethialone as an active substance in its Annex I and Commission Directive 2007 /70/EC of 29 November 2007 amending Directive 98 /8/EC of the European Parliament and of the Council in order to include carbon dioxide as an active substance in Annex IA thereto. By that order, the Commission's Directives 2007 /69/EC and 2007 /70/EC of 29 November 2007 are transposed into national law. It also lays down the requirements to be met by undertakings wishing to continue to market biocidal products and low-risk biocidal products containing difethialone and carbon dioxide, respectively, in order to demonstrate to the Directorate-General for Public Health and Foreign Health of the Ministry of Health and Consumer Affairs, compliance with the conditions of inclusion established in this order. However, since the characteristics of the active substance difetialone make it potentially persistent, prone to bioaccumulation or toxic, or very persistent and very prone to bioaccumulation, this active substance should be the subject of a Assessment of comparative risks at the level of the European Union before its inclusion in Annex I to Royal Decree 1054/2002 of 11 October 2002 is renewed. In drawing up this provision, the sectors concerned and the Autonomous Communities have been consulted. This order is issued under the terms of the final provision of Royal Decree 1054/2002 of 11 October 2002. In its virtue, on a proposal from the Ministers of Health and Consumer Affairs and the Environment, and the Rural and Marine Environment, according to the State Council, I have:

Single item. Amendment of Royal Decree 1054/2002 of 11 October 2002 regulating the evaluation process for the registration, authorisation and placing on the market of biocidal products.

Royal Decree 1054/2002 of 11 October 2002 regulating the evaluation process for the registration, authorisation and placing on the market of biocidal products is amended as follows: Point 3 (difetialone) is included in Annex I (List of active substances for inclusion in biocidal products) with the conditions of inclusion set out in Annex I to this order.

Two. Point 1 (carbon dioxide) with the conditions of inclusion set out in Annex II to this order is included in Annex IA (List of active substances for inclusion in low-risk biocidal products).

Single transient arrangement. Adaptation of authorisations, registrations and marketing conditions.

1. In order to verify compliance with the conditions of inclusion laid down in the Annexes, undertakings which market rodenticides containing difethialone or carbon dioxide may submit to the Directorate until 1 November 2009. General of Public Health and Foreign Health of the Ministry of Health and Consumer Affairs, an application for authorisation to place biocidal products on the market, in accordance with the requirements of Article 8 of Royal Decree 1054/2002 of 11 October 2002, or, where appropriate, a application for mutual recognition as provided for in Article 4 of the Royal Decree itself.

In the case of an application for mutual recognition, all the requirements laid down in Article 4 shall be met, except those duly justified, which can only be completed after obtaining a first authorisation or registration in a Member State, in which case they shall be submitted within two months of the first authorisation or registration. 2. The products for which any of the applications provided for in paragraph 1 have been submitted, and which, at the entry into force of this order, have a national authorization in accordance with the provisions of the transitional provision Royal Decree 1054/2002 of 11 October 2002 may continue to be placed on the market under that authorisation until the relevant decision on its application is made. Where none of the applications provided for in paragraph 1 are submitted for products covered by the said national authorization, their corresponding records shall be deemed to be cancelled and shall no longer be placed on the market. the deadline for which they were authorised and, in any case, 31 October 2011.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2007 /69/EC of 29 November 2007 amending Directive 98 /8/EC of the European Parliament and of the Council of 29 November 2007 on the inclusion of the difetialone as an active substance in Annex I, and Commission Directive 2007 /70/EC of 29 November 2007 amending Directive 98 /8/EC of the European Parliament and of the Council to include carbon dioxide as active substance in its Annex IA.

Final disposition second. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, 4 September 2008. -First Vice-President of the Government and Minister of the Presidency, Maria Teresa Fernández de la Vega Sanz.

ANNEX I Conditions for the inclusion of the active substance difetialone in Annex I to Royal Decree 1054/2002 of 11 October

N. 3 Difetialone (common name)

Naming UIQPA: 3 [3-(4'bromo (1,1'biphenyl) 4-yl) -1,2,3,4-tetrahydro-1-naphthyl] -4-hydroxybenzothiopyran-2-one.

Identification numbers: N. CE to be determined. CAS No 104653-34-1

Minimum purity of the active substance in the marketed product: 976 g/kg.

Date of inclusion: 1 November 2009 Deadline for implementation of the conditions of inclusion (except in the case of biocidal products containing more than one active substance, the period of which shall be the last fixed at the last of the inclusion decisions related to their active substances): 31 October 2011. Date of expiry of the inclusion: 31 October 2014 Type of product: 14 (rodenticides) Specific provisions:

The authorisations shall comply with the following conditions: 1. The nominal concentration of the active substance in the products shall not exceed 0,0025% by weight and only ready-to-use baits shall be authorised.

2. The products must contain an aversive agent and, if appropriate, a dye. 3. Products shall not be used as a trace powder. 4. The direct and indirect exposure of humans, animals to which the substance and the environment is not addressed, shall be reduced to a minimum, taking into account and applying all appropriate risk mitigation measures. These include, inter alia, the restriction for professional use, the establishment of a maximum limit for the packaging and the obligation to use safe and tamper-proof bait boxes.

ANNEX II Conditions for the inclusion of the active substance carbon dioxide in Annex IA to Royal Decree 1054/2002 of 11 October

No. 1 Carbon dioxide (common name)

IUQPA name: Carbon dioxide.

Identification numbers: N. CE: 204-696-9 N. CAS: 124-38-9. Minimum purity of the active substance in the marketed product: 990 ml/litre. Date of inclusion: 1 November 2009. Time limit for the application of the conditions of inclusion (except in the case of biocidal products containing more than one active substance, the period of which shall be the last fixed in the last of the inclusion decisions related to its active substances): October 31, 2011. Date of expiry of the inclusion: 31 October 2019. Product type: 14 (rodenticides).

Specific provisions:

Only for use in gas cartridges ready for use and provided with a holding device.