New Official Register of Biocidal Products according the Royal Decree 1054/2002

Introduction

The implementation of the Directive 98/8/CE Will open in a new window of the European Parliament of 16 February 1998 concerning the placing of biocidal products on the market, transposed to our legal system through the Royal Decree 1054/2002 File pdf. Will open in a new window , of 11 October 2002, amended by the Orden PRE/1982/2007 File pdf. Will open in a new window of 29 June 2007, regulating the assessment process for registration, authorisation and marketing of biocides, provides that biocides that have not been approved under the procedure laid down in this regulation  can not be marketed after a fixed date. Furthermore those biocides can only contain the active substances that are included in Annex I of the Directive 98/8/EC. In Annex V of the above mentioned Royal Decree, there is a classification product-types and their descriptions; according to the purpose, there are 23 Biocidal Product-Types (23 PT).

Once the active substances have been evaluated by the relevant Member State within the review program (COM (2008) 620) established by the European Commission, they are included in Annex I of the Directive 98/8/EC (and consequently, in Annex I of the Royal Decree 1054/2002). The first inclusions were in 2009, and the procedure for approval of biocides in the Official Register of Biocides of the General Directorate of Public Health and Foreign Health (Dirección General de Salud Pública y Sanidad Exterior; DGSA and SE) has started at the same time.

In accordance with the aforementioned legislation, each  company that has a product on the market that contains an active substance included in Annex I of Royal Decree 1054/2002 (Calendar inclusions) File pdf. Will open in a new window , shall submit an application for authorisation / registration to be placed on the market before the date of inclusion of active substance, in accordance with the rules and practices of the Royal Decree, or submit an application for mutual recognition of an authorisation / registration already granted by another Member State. Otherwise, the product must be phased out from the market.

For more information, please see the Update Registration Biocides File pdf. Will open in a new window  (Spanish document).

Procedure for Authorisation / Registration of a Biocidal Product

According  to the kind of application  to be submitted, we will find two types of procedures:

  • Procedure for Authorisation / Registration (AA)- When the first application in the European Union is submitted to Spain under Directive 98/8/EC.

Or,

  • Procedure for Mutual Recognition (AM)- When the first application in the European Union is NOT  submitted to Spain under Directive 98/8/EC. The objective of an application for mutual recognition is to obtain other authorisations of the original reference product requested in the first Member State, either the same or different owner.

Preparation and evaluation of the dossier

After receiving the complete application for authorisation / registration of a product, the Administration begins to study the dossier. For more information, please see the summary of the Administrative Procedure File pdf. Will open in a new window (Spanish document.)

Revision of Directive 98/8/EC

The Directive 98/8/EC was created with the commitment to be reviewed in light of the report on its implementation under Article 18.5. As a result, the Commission has taken some steps File pdf. Will open in a new window . (Spanish document)

EU Commission website provides a homepage with additional information on the Biocidal Products Will open in a new window .

Notes

For new biocidal products:

  • The applications under the previous legislation (Royal Decree 3349/1983) shall be submitted at least six months before the date of inclusion in Annex I of Royal Decree 1054/2002 of the active substance that it contains.

For existing biocidal products:

  • The holders of a biocidal product under the previous legislation (Royal Decree 3349/1983) which want to maintain their products on  the market after the date of inclusion of the active substance in Annex I of Royal Decree 1054/2002, shall submit a dossier satisfying the requirements of the new legislation. If there are changes in the new product compared to the previous one (change of composition, change of owner, etc ...), they should submit the application for such changes, before the date of inclusion of the substance in Annex I.

  • If the change in composition affects the active substance, its concentration or the presence and quantity of the co-formulants responsible for the classification of the preparation, a change in the name of the product shall also be requested.

  • The procedure for the phasing-out  of the products for which  the  application for authorisation / registration (AA) or mutual recognition (AM) has not been submitted before  the date of inclusion in Annex I of active(s)  substance(s)  will be  as follows:

    1. The manufacture of the biocidal product must stop at the date of inclusion in Annex I of the active substance (s).

    2. The deadline to eliminate remaining stocks must be the first of the following dates: either the expiry date of the resolution of the authorisation / registration in the Official Register of Pesticides, or the deadline for compliance with the active substance’s inclusion in Annex I.