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 abovementioned Directive and which is entitled 'List of active substances for inclusion in biocidal products', the active substances which are to be included are to be included. are to be part of a biocidal product in order to be able to register this product in the Official Register of Biocidal Products and, where appropriate, to obtain mutual recognition of registration in 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 Creosote active substance for use in type 8 biocidal products (wood preservatives). This has been done by means of Commission Directive 2011 /71/EU of 26 July 2011 amending Directive 98 /8/EC of the European Parliament and of the Council to include creosote as an active substance in

I.

By this order, the Commission's Directive 2011 /71/EU is transposed into national law. It also lays down the requirements to be met by companies wishing to continue marketing type 8 biocidal products containing creosote, to be accredited to the Directorate-General for Public Health, Quality and Innovation of the Ministry of Health. Health, Social Services and Equality, 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, which has the character of a basic rule, as it is an adaptation to the Community law of Royal Decree 1054/2002 of 11 October 2002, is given in accordance with the provisions of Article 149.1.16. agreement with the provisions of the final provision of Royal Decree 1054/2002 of 11 October 2002.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality and the Minister of Agriculture, Food and Environment, with the prior approval of the Minister of Finance and Public Administrations and, Agreement with the State Council, I have:

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

Annex I to Royal Decree 1054/2002 of 11 October 2002 regulating the assessment process for the registration, authorisation and placing on the market of biocidal products is amended as follows:

Annex I (List of active substances for inclusion in biocidal products) is included in point 45 (creosote), with the inclusion conditions set out in the Annex to this order.

Single additional disposition. Adaptation of authorisations, records and conditions for placing biocidal products on the market with creosote.

In order to verify compliance with the conditions of inclusion set out in the Annex, companies that market type 8 biocidal products containing creosote, shall direct to the Directorate-General for Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality, 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 as 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 must 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.

Single transient arrangement. Products that have a national authorization.

Products which, at the entry into force of this order, have a national authorisation in application of the provisions of the first transitional provision of Royal Decree 1054/2002 of 11 October 2002, may continue by placing on the market under that authorization until the relevant decision is made in respect of their application, provided that they have submitted one of the applications provided for in the single additional provision of this order before of 1 May 2013.

In the event that no application is made for those provided for in the single additional provision of this order, for products that have the said national authorization, their corresponding records, and shall cease to be placed on the market, at the expiry of the period for which they were authorised and, in any case, on 30 April 2015.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2011 /71/EU of 26 July 2011 amending Directive 98 /8/EC of the European Parliament and of the Council of 26 July 2011, including as regards creosote, is transposed into national law. active substance in Annex I.

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" and shall apply from 1 May 2013.

Madrid, May 3, 2012. -Government Vice President and Minister of the Presidency Soraya Saenz de Santamaria Anton.

ANNEX

Conditions for the inclusion of the active substance creosote

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

No. 45. Creosota (common name).

Identification numbers:

CE: 232-287-5.

CAS number: 8001-58-9.

UIQPA Naming: Creosote.

Minimum purity of the active substance in the marketed biocidal product: Grade B or grade C Creosote as specified in European Standard EN 13991:2003.

Date of inclusion: May 1, 2013.

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 will be the last set in the last of the inclusion decisions related to the active substances): 30 April 2015.

Date of inclusion due: April 30, 2018.

Type of biocidal product: 8 (wood protectors).

Specific provisions:

Biocidal products containing creosote may be authorised only for uses in respect of which the Member State granting the authorisation has concluded that there are no appropriate alternatives available on the basis of an analysis of the technical and economic feasibility of the replacement, which shall have been requested by the applicant, and other information available to it. Member States which authorise such biocidal products in their territories shall submit to the Commission, by 31 July 2016 at the latest, a report justifying their conclusion that there are no appropriate alternatives and indicate how the development of alternatives. The Commission shall make such reports available to the public.

The active substance should be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10 (6) of Royal Decree 1054/2002 before its inclusion in this Annex is renewed.

When assessing the application for authorisation of a biocidal product in accordance with Article 5 and Annex VI to Royal Decree 1054/2002, the uses or assumptions of exposure and risks for exposure shall be assessed, where appropriate according to the particular product environmental compartments and stocks that have not been representatively addressed in the risk assessment at the level of the European Union.

The authorities will be subject to the following conditions:

1. Creosote may only be used under the conditions referred to in point 2 of column 2 of entry No 31 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on registration, the assessment, authorisation and restriction of chemicals (REACH), establishing the European Chemicals Agency, amending Directive 1999 /45/EC and repealing Council Regulation (EEC) No 793/93 Council and Commission Regulation (EC) No 1488/94 as well as Council Directive 76 /769/EEC and the Commission Directives 91 /155/EEC, 93 /67/EEC, 93 /105/EC and 2000 /21/EC.

2. Creosote shall not be used for the treatment of wood intended for the uses referred to in point 3 of column 2 of entry No 31 of Annex XVII to Regulation (EC) No 1907/2006.

3. Appropriate risk mitigation measures shall be taken to protect workers, including downstream users, in the face of exposure during the treatment and handling of treated wood, in accordance with Regulation (EC) No 139/2014. 1907/2006 and Directive 2004 /37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens during work (sixth specific Directive within the meaning of Article 16 (1) of Directive 89 /391/EEC) Advice).

4. Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, on the labels and on the safety data sheets, where available, authorised biocidal products must be indicated that the newly treated wood must be stored, after treatment, to be covered or on a hard surface and impermeable (or both) to avoid direct losses to the ground or water and that any losses must be collected for reuse or disposal.