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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 must 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 substance spinosad for use in biocidal products of type 18 (insecticides, acaricides and substances to control other arthropods). This has been done by way of Commission Directive 2010 /72/EU of 4 November 2010 amending Directive 98 /8/EC of the European Parliament and of the Council to include spinosad as an active substance in its Annex I.
By this order, the Commission's Directive 2010 /72/EU is transposed into national law. It also lays down the requirements to be met by companies wishing to continue to market type 18 biocidal products containing spinosad, 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:
Annex I (List of active substances for inclusion in biocidal products) is included in point 37 (spinosad), 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 spinosad.
In order to verify compliance with the conditions of inclusion set out in the Annex, companies which place biocidal products of type 18 containing spinosad shall direct the Directorate-General for Public Health and External 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 October 2002, or, where appropriate, an application for recognition According to the provisions of Article 4 of the Royal Decree itself.
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 November 2012.
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 31 October 2014.
Final disposition first. Incorporation of European Union law.
By this order, Commission Directive 2010 /72/EU of 4 November 2010 amending Directive 98 /8/EC of the European Parliament and of the Council to include spinosad is transposed into national law. 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, September 27, 2011. -Minister of the Presidency, Ramón Jáuregui Atondo.
ANNEX
Conditions for the inclusion of the active substance spinosad
Conditions for the inclusion of the active substance spinosad in Annex I to Royal Decree 1054/2002 of 11 October 2002.
No. 37. Spinosad (common name).
Identification numbers:
CE: 434-300-1.
CAS No. 168316-95-8.
IUQPA Denomination: Spinosad is a mixture of 50-95% of spinosin A and 5-50% of spinosin D.
Spinosine A (2R, 3aS, 5aR, 5bS, 9S, 13S, 14R, 16aS, 16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manopyranosyl) oxy]-13- {[(2R, 5S, 6R) -5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2-yl] oxy} -9-ethyl-2,3, 3a, 5a, 5b, 6,9,10,11,12,13,14,16a, 16b-tetradecahydro-14-methyl-1H-as-indacene [3,2-d] oxacyclododecin-7,15-dione.
CAS No. 131929-60-7.
Spinosine D (2S, 3aR, 5aS, 5bS, 9S, 13S, 14R, 16aS, 16bS)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manopyranosyl) oxy]-13-{[(2R, 5S, 6R)-5-(dimethylamino) tetrahydro-6-methyl-2H-piran-2-yl] oxy}-9-ethyl-2,3, 3a, 5a, 5b, 6,9,10,11,12,13,14,16a, 16b tetradecahydro-4,14-dimethyl-1H-as-indacene [3,2-d] oxacyclododecin-7,15-dione. CAS No. 131929-63-0.
Minimum purity of the active substance in the marketed biocidal product: 850g/kg.
Date of inclusion: November 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 October 2014.
Include due date: October 31, 2022.
Type of biocidal product: 18 (insecticides, acaricides and products to control other arthropods).
Specific provisions:
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI to Royal Decree 1054/2002, the uses or assumptions of exposure and the risks to the products shall be assessed, where appropriate compartments and stocks that have not been representatively addressed in the risk assessment at European level.
The authorities will be subject to the following conditions:
-Products authorised for professional use by spraying must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that the risks to professional users can be reduced to an acceptable level by other means.
-In the case of biocidal products containing spinosad which may lead to residues in food or feed, the need to establish new or to amend existing maximum residue limits (MRLs) shall be verified, Regulation (EC) No 470/2009 and/or Regulation (EC) No 396/2005 and take the necessary risk mitigation measures to ensure that the applicable MRLs are not exceeded.
