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 active substances: dazomet for use in biocidal products of type 8 (wood preservatives) and N, N-diethyl-meta-toluamide for use in biocidal products of type 19 (repelling and attractant).

This has been done by way of Commission Directive 2010 /50/EU of 10 August 2010 amending Directive 98 /8/EC of the European Parliament and of the Council to include dazomet as an active substance in Annex I thereto, and in Commission Directive 2010 /51/EU of 11 August 2010 amending Directive 98 /8/EU of the European Parliament and of the Council to include N, N-diethyl-meta-toluamide as an active substance in its Annex I.

By this order, the Commission's aforementioned Directives 2010 /50/EU and 2010 /51/EU are transposed into national law. It also lays down the requirements to be met by undertakings wishing to continue to market type 8 biocidal products containing dazomet and type 19 biocidal products containing N, N-diethyl-meta-toluamide, to be accredited to the Directorate-General for Public Health and Foreign Health of the Ministry of Health, Social Policy 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 Ministries of Health, Social Policy and Equality and Environment, and Rural and Marine Environment, with the prior approval of the Third Vice President of the Government and Minister of Territorial Policy and Public Administration, according to 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:

Points 34 (dazomet) and 35 (N, N-diethyl-meta-toluamide) 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.

Single additional disposition. Adaptation of authorisations, records and conditions for placing biocidal products on the market with dazomet and N, N-diethyl-meta-toluamide.

To verify compliance with the conditions of inclusion set out in the Annex, companies that market type 8 biocidal products containing dazomet or biocidal products of type 19 containing N, N-diethyl-meta-toluamide, shall direct to the Directorate-General for Public Health and Foreign Health of the Ministry of Health, Social Policy 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 of October, or, where appropriate, a request for mutual recognition as provided for in the 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 August 2012.

In the event that no application is made for those provided for in the said single additional provision for products with the said national authorization, their corresponding records shall be deemed to be cancelled, and they must cease to be placed on the market, at the expiry of the period for which they were authorised and, in any case, on 31 July 2014.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2010 /50/EU of 10 August 2010 amending Directive 98 /8/EC of the European Parliament and of the Council to include dazomet is transposed into national law. as an active substance in Annex I and Commission Directive 2010 /51EU of 11 August 2010 amending Directive 98 /8/EC of the European Parliament and of the Council to include N, N-diethyl-meta-toluamide as an 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".

Madrid, April 4, 2011. -Minister of the Presidency, Ramón Jáuregui Atondo.

ANNEX

Conditions for inclusion of biocidal active substances dazomet and N, N-diethyl-meta-toluamide

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

No. 34. Dazomet (common name).

IUQPA Name: Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione.

Identification numbers:

CE 208-576-7.

CAS 533-74-4.

Minimum purity of the substance in the marketed biocidal product: 960g/Kg.

Date of inclusion: August 1, 2012.

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): 31 July 2014.

Include expiration date: July 31, 2022.

Type of biocidal product: 8 (wood protectors).

Specific provisions: When assessing the application for authorisation of a product, as provided for in Article 5 and Annex VI to Royal Decree 1054/2002, the uses or assumptions of exposure shall be assessed, where appropriate the risks to compartments and stocks that have not been representatively addressed in the risk assessment at the level of the European Union. In particular, when preceding, any use other than the professional use on the outside for the repairer treatment of wooden posts must be evaluated by the insertion of granules.

The authorisations shall be subject to the following condition: Biocides authorised for industrial and/or professional use shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for authorisation of the biocidal product that risks to industrial and/or professional users may be reduced to an acceptable level by other means.

Two. Conditions for the inclusion of the active substance N, N-diethyl-meta-toluamide in Annex I to Royal Decree 1054/2002 of 11 October 2002:

No. 35. N, N-diethyl-meta-toluamide (common name).

UIQPA Name: N, N-diethyl-m-toluamide.

Identification numbers:

CE 205-149-7.

CAS 134-62-3.

Minimum purity of the substance in the marketed biocidal product: 970g/Kg.

Date of inclusion: August 1, 2012.

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) 31 July 2014.

Include expiration date: July 31, 2022.

Type of biocidal product: 19 (Repelent and attractant).

Specific provisions. The authorisations shall be subject to the following conditions:

1. Direct and indirect exposure of human beings shall be minimised by the study and implementation of appropriate risk mitigation measures, including, where appropriate, instructions on the quantity and frequency of the application of the product on human skin.

2. The labels of biocidal products intended for application on the skin, hair or clothing of human beings shall indicate that, in children aged between two and 12 years, the product should only be used in a restricted manner and that it should not be used in minor children two years, unless it is demonstrated in the application for authorisation of the product that the product complies with the requirements of Article 5 and of Annex VI to Royal Decree 1054/2002 without such measures.

3. The products must contain ingredients that deter ingestion.