1. Legal Basis

The granting of exemptions for defence reasons is supported by:  Art. 2.3 of the REACH regulation, Art. 1.4 of the CLP regulation and the fourth additional provision of Law 7/2022, of April 8, these provisions are established at the national level in:

• The Royal Decree 312/2023, of 25 April, provides the possibility to grant exemptions from compliance with certain regulations for substances, mixtures or articles containing them, for defence reasons.
• The Order DEF/828/2024, of 29 July, establishes the national procedure to submit and to grant an exemption.

The exemption procedure is complemented by the specific procedure PE/54/01“Exemption from compliance with certain regulations on substances, mixtures or articles for defence reasons” which is based on the Code of Conduct (CoC) on REACH Defence Exemptions, established in EDA_REACH Working group, within the framework established by EDA to be able to request an exemption for defense reasons.

2. Description of National Procedure

2.1. Overview

This is an abstract of the national procedure, which is aligned with the EDA CoC for REACH defence exemptions, that also established the framework for requesting an exemption for defense reasons on how to manage the exemption applications.

Manufacturers, importers or intermediate users may request exemptions from the Ministry of Defense requirements imposed by community regulations, when they are in any of the situations established in Art. 3 of Royal Decree 312/2023.

The application will be submitted at the Spanish MoD electronic headquarters, to the General Director of Armament and Material (DGAM) as the competent authority will resolve the request.

A technical and administrative file must be submitted, which will contain, in addition to what is required by Art. 66 of Law 39/2015, of October 1, the following information and documentation:

a) Identification of the applicant.

b) Identification and specific use of the substance, mixture or article containing it for which it is requested.

c) Assumption of Art.3 of the Royal Decree 312/2023, of April 25, on which it is based and its justification.

d) Technical report indicating, at least, the risks to human health and the environment, as well as its safe use throughout its life cycle.

e) Other documentation specified in the national procedure PE/54/01 according to the type of file

2.2. Scope

This procedure applies to exemption files for defense reasons for a chemical substance, as such or in the form of a mixture or contained in articles that is based on any of the assumptions established in Art.3 of Royal Decree 312/2023, of April 25.

2.3. Template/Form

The application will be submitted at the Spanish MoD electronic headquarters, through the national procedure request for exemption for defense reasons (Solicitud de Exención por Razones de Defensa, código SIA: 687336).

2.4. Charges/Fees

The costs incurred by carrying out the tests will be borne by the applicant. For costs incurred within the scope of the Ministry of Defence, whether for tests carried out or for other services provided, current legislation will apply.

2.5. Decision-making process

Once the documentation received has been evaluated, Sub-Directorate General for inspection and Regulation (SDGINREG), as the entity responsible for managing the exemption file and with the support of an interdepartmental working group, will establish the viability of the application. If it is considered necessary to have more information for the decision-making, it will contact the applicant through the Spanish MoD electronic headquarters.

The SDGINREG will prepare a report, which will end with the proposal for a resolution to the DGAM authority.

In those applications that have an exemption for defence reasons granted by another country belonging to the European Union, this will be taken into account in case its validation is appropriate.

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 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.

After the deadline has elapsed, the applicant may reapply for the exemption as if it were a new one.

3. Description of National Safety and Traceability Measures

Applicants shall comply with national rules on worker safety, occupational health and the environment throughout the life cycle of the substance, mixture or article, including disposal.

In certain cases and under certain conditions, a chemical safety assessment (CSA) will be required when the application concerns chemical substances, on their own or in mixtures or articles, with a medium or high level of risk, as specified in procedure PE/54/01.

The government body that reviews the CSA is the SDGINREG. It will process the request for exemption and may request the support, if necessary, of an interdepartmental working group.

A Chemical Safety Report (CSR) is requested, as in the REACH authorization process.

4. National Bodies Involved

The Spanish MoD leads the implementation of the exemption procedure, in particular by DGAM with the support of SDGINREG. The Spanish MoD grants the defense exemption and the Ministries of Health and Environment are informed.

5. Where to File an Application

Applications must be submitted to the Spanish MoD electronic headquarters at the Internet address https://sede.defensa.gob.es/acceda/procedimientos (see 2.3).

The documentation of the exemption file specified in procedure PE/54/01 must be attached and will depend on the type of file, which the applicant must identify, based on the danger and the quantity manufactured or imported of said substance, mixture or article.

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

Art.9.2 of Order DEF/828/2024 states that in those applications that have an exemption for defense reasons granted by another country belonging to the European Union, this will be taken into account in case its validation is appropriate, however, the exemption decision will be based on the assessment according to national procedure.

7. Number of Exemptions Granted

To date, one defence exemption has been granted.

8. Contact Info

Unit of Laboratories and REACH Exemption.
exenciones_reach@oc.mde.es
Sub-Directorate of Inspection and Regulation of DGAM
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: 10 December 2024