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 Cis-Tricos-9-ene active substances for use in biocidal products of type 19 (repellent and attractant) and hydrogen cyanide for use in biocidal products of type 8 (wood preservatives), type 14 (rodenticides) and type 18 (insecticides, acaricides and products to control other arthropods). In addition, the Commission has also approved the extension of the inclusion in Annex I of Directive 98 /8/EC of the active substance nonanoic acid to product type 2 (disinfectants used in the areas of private life and public health and other biocidal products).

This has been done by way of Commission Directive 2012/38/EU of 23 November 2012 amending Directive 98 /8/EC of the European Parliament and of the Council to include cis-Tricos-9-ene as active substance in its Annex I, by means of Commission Directive 2012/42/EU of 26 November 2012 amending Directive 98 /8/EC of the European Parliament and of the Council to include hydrogen cyanide as a substance active in its Annex I, and by means of Commission Directive 2012/41/EU of 26 November 2012 on the amend Directive 98 /8/EC of the European Parliament and of the Council to extend the inclusion in Annex I of the active substance nonanoic acid to product type 2.

By this order, the Commission's aforementioned Directives 2012 /38/EU, 2012 /41/EU and 2012 /42/EU are transposed into national law. It also lays down the requirements to be met by undertakings wishing to continue to trade biocidal products of type 19 containing cis-Tricos-9-ene, type 2 biocidal products containing nonanoic acid or biocidal products of type 8, type 14 or type 18 containing hydrogen cyanide to accredit to the General Directorate of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality, compliance with the conditions of inclusion established in this order.

In the preparation of this provision have been heard the sectors affected and consulted the autonomous communities and the cities of Ceuta and Melilla.

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, 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:

These are included in Annex I (List of active substances for inclusion in biocidal products): 59 (cis-Tric-9-ene) and 60 (hydrogen cyanide) with the inclusion conditions listed in the Annex to this order and added in entry No 41 (nonanoic acid) the conditions of inclusion 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 cis-Tricos-9-ene, nonanoic acid and hydrogen cyanide.

To verify compliance with the conditions of inclusion set out in the Annex, companies placing on the market biocidal products of type 19 containing cis-Tricos-9-ene, type 2 biocidal products containing nonanoic acid or biocidal products of type 8, type 14 or type 18 containing hydrogen cyanide, shall direct to the Directorate-General for Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality, an application for a marketing authorisation of biocidal products, in accordance with the requirements of Article 8 of Royal Decree 1054/2002 of 11 September 2002. October, or, where appropriate, a request 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 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.

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 October 2014.

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 30 September 2016.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2012/38/EU of 23 November 2012 amending Directive 98 /8/EC of the European Parliament and of the Council in a manner which includes the provisions of Directive 2012/38/EU is transposed into national law. cis-Tricos-9-ene as an active substance in Annex I, Commission Directive 2012/41/EU of 26 November 2012 amending Directive 98 /8/EC of the European Parliament and of the Council in order to extend the inclusion in Annex I thereto of the active substance nonanoic acid at product type 2 and Commission Directive 2012/42/EU of 26 November 2012, amending Directive 98 /8/EC of the European Parliament and of the Council to include hydrogen cyanide as an active substance in Annex I thereto.

Final disposition second. Staff costs.

The forecasts contained in this order will not entail an increase in personnel costs for any concept, and will be carried out with the means available in the affected ministries and their autonomous bodies.

Final disposition third. Entry into force.

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

Madrid, September 17, 2013. -Government Vice President and Minister of the Presidency Soraya Saenz de Santamaria Anton.

ANNEX

(Conditions for inclusion of the active substances cis-Tricos-9-ene, nonanoic acid for product type 2 and hydrogen cyanide)

One. Conditions for the inclusion of the active substance cis-Tricos-9-ene in Annex I to Royal Decree 1054/2002 of 11 October 2002:

No. 59.

Common name: cis-Tricos-9-ene (Muscalure).

IUQPA Denomination: cis-Tricos-9-en; (Z) -Tricos-9-ene.

Identification numbers:

CE: 248-505-7.

CAS: 27519-02-4.

Level of minimum purity of the active substance (*): 801 g/kg.

Date of inclusion: October 1, 2014.

Term of expiration of the conditions of inclusion, unless one of the exceptions set out in the footnote under this heading applies (**): 30 September 2016.

Include Due Date: September 30, 2024.

Product type: 19 (repellent and attractant).

Specific provisions (***):

The risk assessment at Union level did not consider all possible uses and exposure scenarios; certain uses and assumptions of exposure, such as outdoor use and food exposure, were excluded. feed. 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 the risks to stocks shall be examined where appropriate according to the particular product human and environmental compartments that have not been representatively addressed in the risk assessment at Union level.

With regard to biocidal products containing cis-Tricos-9-ene which may result in residues in food or feed, the need to establish new or amend existing maximum residue limits (MRLs) shall be verified. according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and appropriate risk mitigation measures shall be taken to ensure that the applicable maximum residue limits are not exceeded.

(*) The purity indicated in this heading is the minimum degree of purity of the active substance used for the assessment carried out in accordance with Article 11. The active substance in the marketed biocidal product may be of equal or different purity, if it is shown to be technically equivalent to the substance evaluated.

(**) In the case of biocidal products containing more than one active substance to which the first transitional provision of this royal decree applies, the time limit for the expiry of the conditions of inclusion is that of the last of its active substances included in this Annex. In the case of biocidal products for which the first authorisation has been granted after the date corresponding to 120 days before the initial due date for the expiry of the conditions of inclusion, and for which a full application for mutual recognition in accordance with Article 4 (1), within 60 days of the granting of the first authorisation, the time limit for the expiry of the conditions of inclusion, in relation to that application is extended to 120 days from the date of receipt of the complete mutual recognition application. In the case of biocidal products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4 (4), the time limit for the expiry of the conditions for inclusion is extended to 30 days from the date of entry into force of this Regulation. of the date of adoption of the Commission decision in accordance with the second subparagraph of Article 4 (4) of Directive 98 /8/EC.

(***) For the purposes of applying the common principles of Annex VI, the content and conclusions of the assessment reports can be found on the Commission's website: http://ec.europa.eu/comm/environment/biocides/index.htm

Two. Extension of the conditions for the inclusion of the active substance nonanoic acid in Annex I to Royal Decree 1054/2002 of 11 October 2002.

No. 41.

Date of inclusion: October 1, 2014.

Term of expiration of the conditions of inclusion, unless one of the exceptions set out in the footnote under this heading applies (**): 30 September 2016.

Include Due Date: September 30, 2024.

Type of product: 2 (disinfectants used in the areas of private life and public health and other biocidal products).

Specific provisions (***):

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 shall be examined where appropriate according to the particular product for human populations and environmental compartments that have not been representatively addressed in the risk assessment at Union level.

It shall be ensured that the authorisations of products intended for non-professional use are conditional on the packaging being designed to minimise the exposure of the user, unless in the application for authorisation of the product it can be demonstrated that risks to human health can be reduced to acceptable levels by other means.

(**) In the case of biocidal products containing more than one active substance to which the first transitional provision of this royal decree applies, the time limit for the expiry of the conditions of inclusion is that of the last of its active substances included in this Annex. In the case of biocidal products for which the first authorisation has been granted after the date corresponding to 120 days before the initial due date for the expiry of the conditions of inclusion, and for which a full application for mutual recognition in accordance with Article 4 (1), within 60 days of the granting of the first authorisation, the time limit for the expiry of the conditions of inclusion, in relation to that application is extended to 120 days from the date of receipt of the complete mutual recognition application. In the case of biocidal products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4 (4), the time limit for the expiry of the conditions for inclusion is extended to 30 days from the date of entry into force of this Regulation. of the date of adoption of the Commission decision in accordance with the second subparagraph of Article 4 (4) of Directive 98 /8/EC.

(***) For the purposes of applying the common principles of Annex VI, the content and conclusions of the assessment reports can be found on the Commission's website: http://ec.europa.eu/comm/environment/biocides/index.htm

Three. Conditions for the inclusion of the active substance hydrogen cyanide in Annex I to Royal Decree 1054/2002 of 11 October 2002.

No. 60.

Common name: Hydrogen cyanide.

IUQPA name: Hydrogen cyanide.

Identification numbers:

CE: 200-821-6.

CAS: 74-90-8.

Level of minimum purity of the active substance (*): 976 g/kg.

Date of inclusion: October 1, 2014.

Term of expiration of the conditions of inclusion, unless one of the exceptions set out in the footnote under this heading applies (**): 30 September 2016.

Include Due Date: September 30, 2024.

Product type: 8 (wood protectors), 14 (rodenticides) and 18 (insecticides, acaricides, and products to control other arthropods).

Specific provisions (***):

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 human populations and environmental compartments that have not been representatively addressed in the risk assessment at Union level.

It shall be ensured that the authorisations of biocidal products for use as fumigant are subject to the following conditions:

1) products will only be provided to professionals with appropriate training to use them, and only they will be able to use them;

2) Secure operational procedures shall be established for operators and persons present during fumigation and ventilation;

3) Biocides shall be used with appropriate personal protective equipment, including, where appropriate, self-contained breathing apparatus and gas-tight clothing;

4) Reentry in the fumigated areas shall be prohibited until such time as there has been a level of air concentration that is safe for operators and persons present by ventilation;

5) the exposure during and after ventilation should be prevented from exceeding safe levels for operators and persons present by the establishment of a supervised exclusion zone;

6. prior to fumigation, any food or porous material that may absorb the active substance, except wood intended for treatment, must be removed from the area to be fumigated, or protected from absorption by adequate means, and the area to be fumigated shall be protected against accidental inflammation.

(*) The purity indicated in this heading is the minimum degree of purity of the active substance used for the assessment carried out in accordance with Article 11. The active substance in the marketed biocidal product may be of equal or different purity, if it is shown to be technically equivalent to the substance evaluated.

(**) In the case of biocidal products containing more than one active substance to which the first transitional provision of this royal decree applies, the time limit for the expiry of the conditions of inclusion is that of the last of its active substances included in this Annex. In the case of biocidal products for which the first authorisation has been granted after the date corresponding to 120 days before the initial due date for the expiry of the conditions of inclusion, and for which a full application for mutual recognition in accordance with Article 4 (1), within 60 days of the granting of the first authorisation, the time limit for the expiry of the conditions of inclusion, in relation to that application is extended to 120 days from the date of receipt of the complete mutual recognition application. In the case of biocidal products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4 (4), the time limit for the expiry of the conditions for inclusion is extended to 30 days from the date of entry into force of this Regulation. of the date of adoption of the Commission decision in accordance with the second subparagraph of Article 4 (4) of Directive 98 /8/EC.

(***) For the purposes of applying the common principles of Annex VI, the content and conclusions of the assessment reports can be found on the Commission's website: http://ec.europa.eu/comm/environment/biocides/index.htm.