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France

1. Legal Basis

The granting of a defence exemption from the REACH Regulation (article 2.3) implies the integration of a legal basis into the French code. This requires 3 hierarchic levels of code:

  • The legislative part L.521-1 of the French environmental code has been modified by an ordinance on the 26th of February 2009, integrating the part III that allows administrative authorities to grant exemptions from REACH in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence.
  • The regulative part R.521-1 of the French environmental code have been created by a decree issued on the 17th of February 2010, that details the procedure for acknowledgment (see Conditions/procedures for acknowledgment on this page below) and content of the decision.
  • An Order, forecasted by the previous decree, issued on the 22nd of March 2011 details the national procedure (see Description of National Procedure on this page below).

2. Description of National Procedure

2.1. Overview

The applicant has to submit an exemption dossier to the MoD and the Ministry in charge of Environmental affairs (MoE). The exemption dossier consists of two sub-dossiers: an administrative dossier and a technical dossier:

  • The administrative dossier, which aims to give a quick overview of the relevance of the exemption dossier, must provide the following information:
    • name(s) and reference(s) of applicant(s)
    • names and references of beneficiaries if they differ from applicant(s)
    • reasons of the exemption application
    • reference(s) of concerned substance(s), mixture(s) or article(s)
      their uses and quantities
    • concerned defence operation(s) and justification of defence interest
    • start date and desired duration of defence exemption
      REACH obligation(s) to which it seems impossible to conform

Two copies of this sub-dossier must be sent to both MoD and MoE, against a receipt of deposit.

  • The technical dossier features 2 parts:
  • A “defence interest” description which contains all the information useful to testify the necessity to apply for a defence exemption. It must go deeper into information given by the administrative dossier. Detailed composition of the “defence interest” is described in annex I of the decree as follows:
    • Reference(s) of defence operation(s)
    • MoD’s department in charge
    • Purpose of the dossier
    • Role of the applicant(s)
    • Constraints in terms of calendar of the applicant(s)
      Accurate description of the substance(s), mixture(s) or article(s), featuring technical reference(s), trade name(s) and considered suppliers.
    • Use of the product for which the exemption is requested and full description of its implementation into the supply chain of the operation(s). The role of each applicant and beneficiary must also be explained.
    • Specific use of the product for the operation(s) and criticality of the product for obtaining targeted performances.
      Reasons which make compliance to REACH obligations impossible, adding encountered difficulties and concerned beneficiaries.
    • Analysis of possible alternatives at all levels (technological, industrial, conceptual, procurement). The analysis must detail advantages and drawbacks of each solution in terms of performances, costs, deadlines, durability, and security of procurements
    • Description of international initiatives and their results if the exemption request relates to international issues such as exemption dossiers in other countries, distributed production, import/export

Two copies of this sub-dossier must be sent to the MoD only.

  • A “risks mitigation” report, featuring national safeguard measures that will be taken by applicant(s) in case the defence exemption would be granted. Each health and environmental risk linked to the manufacture and use of substance(s), mixture(s) or article(s) need to be detailed. Information to be provided in this report depends on the REACH obligation(s) to which it seems impossible to conform.

Two copies of this sub-dossier will be sent to both MoE and MoD.

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

Applications for exemption include a catch-all clause for cases not specified in the risk management technical sub-dossier annex.

It is possible for stakeholders to apply for an exemption from the REACH Regulation in its entirety (from all provisions/articles). In this case, the applicant should give the information requested for all relevant cases of “risk management” technical sub-dossier.

2.3. Template/Form

Applicants are not required to fill in a specific formal document/template or form when they apply for a defence exemption.

2.4. Charges/Fees

There are no charges/fees foreseen to be paid by stakeholders to the MoD, when applying for a defence exemption.

2.5. Decision-making process

The Defence interest will be assessed by the MoD, then MoE will contribute to the health and environmental risks assessment. The final decision will be taken by both MoD and MoE with possible exceptions. The only exception to this rule applies to emergency situations: in such cases, MoD alone will take the decision.

The final decision granting the defence exemption is notified to applicants and beneficiaries and features:

  • Name of applicants and beneficiaries if they differ from applicants
  • Substance(s), mixture(s) or article(s) concerned by the exemption
  • Defence exemption’s national number
  • Concerned defence operation(s)
  • Concerned quantities
  • Scope
  • Limit of validity of the defence exemption
  • Deadline for requesting an extension of this exemption
  • Potential obligations those beneficiaries have to respect, especially in terms of risk mitigation.

2.6. Validity period

There is a specific validity duration when the exemption is granted. The validity duration is decided on a case-by-case basis, for instance, similar to the authorisation process (4, 7 or 12 years).

After an exemption has been granted and during its validity period, the applicant to which the exemption has been granted is required to (re-)justify the requirements. On a yearly basis, the applicant must report on the potential requirements for implementation mentioned in the granted defence exemption decision (article 8 of Order n° DEFD1106196A).

2.7. Extension

It is possible to provide an extension of the initial validity period of the defence exemption. The request for extension is made up of an administrative dossier and a technical dossier, just like the initial defence exemption request, which must justify the extension and the implementation conditions (article 10 of Order n° DEFD1106196A).

3. Description of National Safety and Traceability Measures

The National Safeguard Measures mirror those imposed by REACH (see “risks mitigation” sub-dossier in the “Description of National Procedure”).
In certain cases and under certain conditions, a Chemical Safety Assessment (CSA) is required. It is requested in the “risk management” technical sub-dossier, when the defence exemption request is related to:

  1. substance registration when used for defence purposes above 10 tonnes per year;
  2. authorisation or restriction procedures, if not already supplied as regards registration exemption request.

The “risk management” technical sub-dossier is addressed to the MoE.

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

4. National Bodies Involved

The setup of the defence exemption procedure is led by the MoD in connection with MoE.

5. Where to File an Application

It is recommended to have a preliminary contact with:
Ministère des armées (MoD)
SGA/DTIE
Environmental office
Postal address: 60 Boulevard du Général Martial Valin – CS21623 F-75509 Paris Cedex 15, France
Email: dtie-bmrc.expert-hn.fct@intradef.gouv.fr

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

Exemptions
There is no automatic acknowledgment/recognition of foreign defence exemption decisions.

7. Number of Exemptions Granted

To date, 3 defence exemptions have been granted.

8. Contact Info

Ministère des armées (MoD)
DGA/DT (Technical Directorate)
Materials, Components & Environmental risk division
Postal address: PC 62, 60 Boulevard du Général Martial Valin – CS21623 F – 75509 Paris Cedex 15, France

9. Links to national websites

French MoD website: http://www.defense.gouv.fr

French MoE website: https://www.ecologie.gouv.fr/

https://www.ixarm.com/fr/reglement-reach

 

Last Update: 14 November, 2023