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 into national law Directive 98 /8/EC of the European Parliament and of the European Parliament Council of 16 February 1998 concerning the placing of biocidal products on the market.

In Annex I to that royal decree, which coincides with that of the same number of the said Directive, which is entitled 'List of active substances for inclusion in biocidal products', the active substances to be included must be included in advance. to be part of a biocidal product in order to register it in the Official Register of Biocidal Products and, where appropriate, to be able to obtain 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 EU Commission has approved the inclusion in Annex I of Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 on the active substances thiabendazole and tebuconazole, for use in biocidal products of the type of wood protectors.

This has been done by way of Commission Directive 2008 /85/EC of 5 September 2008 amending Directive 98 /8/EC of the European Parliament and of the Council to include thiabendazole as a substance active in Annex I and Commission Directive 2008 /86/EC of 5 September 2008 amending Directive 98 /8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto.

By this order, the Commission's Directives 2008 /85/EC and 2008 /86/EC are transposed into national law. It also lays down the requirements to be met by undertakings wishing to continue to trade biocidal products of the type protective wood containing thiabendazole or tebuconazole to be accredited to the Directorate-General for Public Health and Health External Ministry of Health and Consumer Affairs, compliance with the conditions of inclusion established in this order.

In the preparation of this provision, the sectors affected 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 the proposal of 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:

Points 12 (tiabendazole) and 13 (tebuconazole) are included in Annex I (list of active substances for inclusion in biocidal products), with the inclusion conditions set out in the Annex to this order.

Additional disposition first. Adaptation of authorisations, records and conditions for placing biocidal products on the market with thiabendazole.

1. In order to verify compliance with the conditions of inclusion laid down in the Annexes, undertakings placing wood preservatives containing thiabendazole may submit to the Directorate-General for Public Health and External Health 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, an application for mutual recognition, provided for in Article 4 of the same royal decree.

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. Products which, at the entry into force of this order, have a national authorisation in application of the provisions laid down in the first transitional provision of Royal Decree 1054/2002 of 11 October 2002, may continue to be placed on the market under such authorisation until the relevant decision is made in respect of their application, provided that they have submitted some of the applications referred to in paragraph 1 before 1 July 2010.

In the event that no application is made for those provided for in paragraph 1 for products with the said national authorization, their corresponding records shall be deemed to be cancelled, and shall cease to be be placed on the market, at the expiry of the period for which they were authorised and, in any case, on 30 June 2012.

Additional provision second. Adaptation of authorisations, records and conditions for placing biocidal products on the market containing tebuconazole.

1. In order to verify compliance with the conditions of inclusion laid down in the Annexes, undertakings placing wood preservatives containing tebuconazole may submit to the Directorate-General for Public Health and External Health Ministry of Health and Consumer Affairs an application for the 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 request for mutual recognition, provided for in Article 4 of the same royal decree.

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. Products which, at the entry into force of this order, have a national authorisation in application of the provisions laid down in the first transitional provision of Royal Decree 1054/2002 of 11 October 2002, may continue to be placed on the market under such authorisation until the relevant decision is made in respect of their application, provided that they have submitted some of the applications referred to in paragraph 1 before 1 April 2010.

In the event that no application is made for those provided for in paragraph 1 for products with the said national authorization, their corresponding records shall be deemed to be cancelled, and shall cease to be be placed on the market, at the expiry of the period for which they were authorised and, in any case, on 31 March 2012.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2008 /85/EC of 5 September 2008 amending Directive 98 /8/EC of the European Parliament and of the Council, including the tiabendazole as an active substance in Annex I and Commission Directive 2008 /86/EC of 5 September 2008 amending Directive 98 /8/EC of the European Parliament and of the Council to include tebuconazole as a substance active in Annex I.

Final disposition second. Entry into force.

This order will take effect the day following your publication in the "Official State Bulletin".

Madrid, April 2, 2009. -First Vice-President of the Government and Minister of the Presidency, María Teresa Fernández de la Vega Sanz.

ANNEX

(Conditions for the inclusion of active substances thiabendazole and tebuconazole)

One. Conditions for the inclusion of the active substance thiabendazole in Annex I to Royal Decree 1054/2002 of 11 October 2002.

No. 12. Tiabendazole (common name).

IUQPA Name: 2-thiazol-4-yl-1H-benzimidazole.

Identification numbers:

CE: 205-725-8.

CAS No. 148-79-8.

Minimum purity of active substance in the marketed product: 985 g/kg.

Date of inclusion: July 1, 2010.

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 in the last of the inclusion decisions related to their active substance). active substances): 30 June 2012.

Include Due Date: June 30, 2020.

Product type: 8 (wood protectors).

Specific provisions:

The authorities will be subject to the following conditions:

In view of the assumptions established during the risk assessment, products authorised for industrial and/or professional use in relation to applications by immersion and double vacuum should be used with the appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

In view of the risk identified for soil and aquatic compartments, appropriate risk mitigation measures should be taken to protect such compartments. In particular, the labels and/or safety data sheets of products authorised for industrial use must indicate that the newly treated wood has to be stored after the treatment is covered or on a hard and impermeable surface, to prevent direct spills to the soil or water, and that spills have to be collected for reuse or disposal.

The use of products for the in situ treatment of wood on the outside or for wood that is exposed to the effects of weathering shall not be authorised unless data are submitted demonstrating that the product is it complies with the requirements laid down in Article 5 and in Annex VI to Royal Decree 1054/2002, if applicable by the application of appropriate risk mitigation measures.

Two. Conditions for the inclusion of the active substance tebuconazole in Annex I to Royal Decree 1054/2002 of 11 October 2002.

No. 13. Tebuconazole (common name).

IUQPA Name: 1-(4-chlorphenyl) -4-4-dimethyl-3-(1,2,4-triazol-1-ylmethyl) pentan-3-ol.

Identification numbers:

CE: 403-640-2.

CAS No. 107534-96-3.

Minimum purity of active substance in the marketed product: 950 g/kg.

Date of inclusion: April 1, 2010.

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 in the last of the inclusion decisions related to their active substance). active substances): 31 March 2012.

Include Due Date: March 31, 2020.

Product type: 8 (wood protectors).

Specific provisions:

The authorities will be subject to the following conditions:

In view of the risk identified for soil and aquatic compartments, appropriate risk mitigation measures should be taken to protect such compartments. In particular, the labels and/or safety data sheets of products authorised for industrial use must indicate that the newly treated wood has to be stored after the treatment is covered or on a hard and impermeable surface, to prevent direct spills to the soil or water, and that spills have to be collected for reuse or disposal.

In addition, the use of products for the in situ treatment of wood on the outside or for wood that will be exposed in permanent contact with water shall not be permitted unless data are submitted showing that the product complies with the requirements laid down in Article 5 and in Annex VI to Royal Decree 1054/2002 of 11 October 2002, if applicable by the application of the appropriate risk mitigation measures.