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Spain

1. Legal Basis

The transcription of Art 2.3 of REACH within the Spanish legal framework is carried out at two hierarchical levels:

  • The Royal Decree R.D. 1237/2011, of 8 September provides the possibility to grant exemptions to the REACH Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of the national defence.
  • The Order DEF/1056/2013, of 30 May, establishes the national procedure to submit and to grant an exemption.

The exemption procedure is complemented by the specific procedure PE/54/01 “Exemption procedure to the REACH Regulation of Substances for Use in the Field of Defense” which is based on the Code of Conduct (CoC) on REACH Defence Exemptions, established in EDA_REACH Working group.

2. Description of National Procedure

2.1. Overview

This is an abstract of the national procedure, PE/54/01, which is aligned with the harmonised EDA CoC, on how to manage the REACH exemption dossiers, which are initiated as a result of a request submitted by a supplier company for a specific substance and specific defence use, and which complies with any of the criteria established in Art. 2 of Royal Decree 1237/2011.

The supplier, manufacturer or importer, should submit the application form to the General Director of Armament and Material (DGAM) as the competent authority to resolve the request and issue the corresponding certificate of exemption to the REACH Regulation for defence reasons. A technical and administrative dossier will also be submitted to head office of Ministry of Defence.

The administrative part of this dossier will provide:

  • Information related to the applicant or supplier
  • Main data related with the chemical substance as such or in a mixture or in an article (name, CAS or EU number, manufactured o imported quantities…)
  • Specific defence use
  • Justification. Reason for exemption application, it is important to identify criteria by which the exemption can be granted (Section 2 of RD 1237/2011 indicates the criteria by which a waiver to the REACH regulation may be requested)

The dossier content will be a mirror of articles 10, 12 and 14 of REACH. The supplier must submit additional information depending on several factors, such as confidentiality, grade of concern of the substance, and quantity manufactured or imported for the defence specific use. If the substance is of concern, the applicant should produce a chemical safety assessment and report (CSA/CSR) including exposure scenarios (ES), risks management measures (RMM), a socio-economic analysis (or justification for the exemption) and a substitution plan.

2.2. Scope

Stakeholders can apply for a defence exemption from the following provisions/articles of the REACH Regulation:

  • Article 33 notifications in the supply chain
  • Article 66(1) notifications
  • Registration
  • Authorisation
  • Restriction

It is NOT possible for stakeholders to apply for an exemption from the REACH Regulation in its entirety (from all provisions/articles).

2.3. Template/Form

The applicant is required to fill a specific formal document/template when applying for a defence exemption. The document is accessible in original language (Spanish) via the following link: https://sede.defensa.gob.es/acceda/procedimientos

A copy of the document in original language (Spanish) can be found here: https://api.typeform.com/responses/files/f225b3bca1a406705320bf7e1a0c0e04a9aab091c459ece24b11e1ca0417957f/F5401_01C_Formulario_de_Solicitud_ACCEDA.docx

A pdf format can be downloaded from here: https://www.defensa.gob.es/portalservicios/servicios/industriadefensa/exencionreach/

2.4. Charges/Fees

There are no charges/fees foreseen to be paid by stakeholders to the Ministry of Defence when applying for a defence exemption. A regulation is being approved to include certain fees/charges associated with the submission of an application for defence exemption.

2.5. Decision-making process

A multidisciplinary group of experts (GTER) belonging to the Ministry of Defence is in charge of carrying out the assessment in support to DGAM before granting an exemption.

The exemption dossier is also evaluated by both Health and Environment Ministries.

2.6. Validity period

Each defence exemption has a specific period of validity. The validity period is fixed at 3 years and is the same for all cases. However, in some cases, the duration may be modified on the proposal of the Sub-Directorate for Inspection and Technical Services according to the particularities of the case or other justified reasons.

After an exemption has been granted and during its period of validity, the applicant to whom the exemption has been granted is not required to (re)justify the requirements.

The continuation of the exemption granted during the stipulated period will be conditioned by the permanence of the conditions which allowed the granting of the exemption and may be subject to subrogation.

2.7. Extension

There is no possibility to request an extension.

3. Description of National Safety and Traceability Measures

Suppliers will comply with national regulations regarding worker safety, occupational health and the environment, throughout the substance or article life cycle, including disposal.

In certain cases, and under certain conditions, a Chemical Safety Assessment (CSA) is required. It is indeed required when the application is for chemical substances, as such or in mixtures or articles, with a medium or high level of risk, as specified in the procedure PE/54/01 https://www.defensa.gob.es/Galerias/portalservicios/exencionreach/pe-54-01_ed03_procedimiento_exencion_web.pdf.

The governmental agency that reviews the CSA is the Sub-Directorate General for Inspection, Regulation and Industrial Strategy belonging to the Directorate General for Armament and Material of the Ministry of Defence. It will process the exemption request and may ask for the support, where appropriate, of an interdepartmental working group.

There is a Chemical Safety Report (CSR) requested, as in the REACH authorisation process.

4. National Bodies Involved

The implementation of the REACH exemption procedure is led by the Ministry of Defence, in particular by National Armament Directorate (DGAM) with the support of Sub-Directorate of Inspection, Regulation and Industrial Strategy of Defence (SDGINREID) of the DGAM. This is the Ministry of Defence that grants the defence exemption, in conjunction with the Ministries of Health and Environment (a technical report is requested).

5. Where to File an Application

Applications are to be submitted at the electronic head office of the Ministry of Defence, on the following website: https://sede.defensa.gob.es/acceda/procedimientos within the section “Defence Industry” under the voice: Application for Exemption from the REACH Regulation.

The additional documentation of the exemption file that the applicant must attach, is specified in PE / 54/01 “Exemption to the REACH Regulation of Substances for Use in the Field of Defence” and will depend on the type of file that will lead to the substance for which the exemption is requested. The applicant must identify the type of file according to the hazard and the quantity manufactured or imported of said substance.

6. Conditions/Procedures for Acknowledgment/Recognition of Foreign Defence Exemptions

Art. 2 of Royal Decree 1237/2011, states that: “Possible certified exemptions of the same substance will be taken into account, if this has been granted in other EU countries with harmonization agreements for exemptions”, however, the exemption decision will be based on the assessment according to national procedure.

7. Number of Exemptions Granted

To date, 1 defence exemption has been granted.

8. Contact Info

Unit of Laboratories and REACH Exemption.
exenciones_reach@oc.mde.es
Sub-Directorate of Inspection, Regulation and Industrial Strategy of Defence (SDGINREID)
C/Donoso Cortes 92,
28015-Madrid- SPAIN
Phone: +34 915506125
Fax: +34 915506167

9. Link to national website

http://www.defensa.gob.es/portalservicios/servicios/industriadefensa/exencionreach/

 

Last Update: 14 November, 2023