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 on REACH Defence Exemptions, established in EDA_REACH Working group.
Description of National Procedure
This is an abstract of the national procedure; PE/54/01 , which is aligned with the harmonized CoC, details the way 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 defense use, and which complies with any of the criteria established in Art. 2 of Royal Decree 1237/2011, details the way to manage the REACH exemption dossiers.
The supplier, manufacturer or importer, should submit the application form to the General Director of Armament and Material (DIGAM) as the competent authority to resolve the request and issue the corresponding certificate of exemption to the REACH Regulation for defense reasons. A technical and administrative dossier will be also submitted to head office of Ministry of Defense.
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 defense 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, 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 defense specific use. If the substance is of concern, the applicant should realize 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.
Description of National Safeguard Measures
Suppliers will comply with national regulations regarding worker safety, occupational health and the environment, throughout the substance or article life cycle, including disposal.
A multidisciplinary group of experts (GTER) belonging to the MoD is in charge of carrying out the assessment in support to DGAM before granting an exemption. The exemption certificate is valid for a maximum period of three years (case by case), after which the supplier should apply for renewal if considered.
The exemption dossier is also evaluated by both Health and Environment Ministries.
National Bodies Involved
The implementation of the REACH exemption procedure is led by the Ministry of Defense, in concrete by National Armament Directorate (DGAM) with the support of Subdirectorate of Inspection, Regulation and Industrial Strategy of Defence (SDGINREID) of the DGAM. Ministry of Defense is who grants, in connection with Health and Environmental Ministries (a technical report is requested).
Where to File an Application
The supplier should submit an application at the electronic head office of the Ministry of Defense, and submit it in: https://sede.defensa.gob.es/acceda/procedimientos within the section “Defense Industry” to the procedure of Exemption request to REACH regulation that is there available.
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 Defense” 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.
Conditions/Procedures for Acknowledgment/Recognition of Foreign Defence Exemptions
Number of Exemptions Granted
To date (25/09/2018), no defence exemption has been granted.
Unit of Laboratories and REACH Exemption.
Subdirectorate of Inspection, Regulation and Industrial Strategy of Defence (SDGINREID)
C/Donoso Cortes 92,
Phone: +34 915506125
Fax: +34 915506167
Link to national web site(s) (if any)
Last Update: 19 November 2019