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Sweden

1. Legal Basis

Exemption from the requirements in REACH are to be found in § 24 in regulation (2008:245) regarding chemical products and biotechnical organisms. The regulation has been issued under the provisions of the Environmental Code (1998:808).

The Inspectorate for Medicine and Environmental Health (FIHM) is the Swedish governmental authority granting defence exemptions from the requirements in the REACH regulation as well as the CLP regulation.

FIHM will consult with the Swedish Chemicals Agency (KemI) before granting a defence exemption.

The Inspectorate for Medicine and Environmental Health may in the specific case grant an exemption:

1. from the requirements in the REACH or CLP regulation, if:

  • It is required with consideration to the overall interests of the total defence services, and
  • The exemption relates to the following authorities: the Swedish Armed Forces, the Swedish Defence Materiel Administration, the National Defence Radio Establishment, the Swedish Fortifications Agency and the Swedish Defence Research Agency.

2. from article 33.1 in the Reach regulation, if:

  • It is required with consideration to Swedish defence interests, and the exemption relates to articles that are intended to be used for military purpose.

2. Description of National Procedure

2.1. Overview

The Swedish national defence exemption procedure is based on the EDA “Code of Conduct on REACH Defence Exemptions” (CoC).

The following procedure applies to an application with reference to abovementioned part 1 in § 24 in regulation (2008:245):

The application is to be sent to one of designated defence authorities and by that authority forwarded (3 copies) to FIHM. The defence authority in question is responsible for the application as the applicant. FIHM may request additional information if the application is not complete. When FIHM is of the opinion that the applicant has submitted complete documentation FIHM will establish a draft decision. The draft decision is sent to the Swedish Chemicals Agency for consultation. If necessary, additional information may be requested. The decision is communicated to the applicant if the application is negative, i.e. if FIHM refuses the exemption application. FIHM makes a final decision when the matter is communicated, and consultation has taken place with the Swedish Chemicals Agency. The decision is communicated to the organisation initially making the request for exemption by the applying defence authority.

A time limit is imposed on FIHM´s decision and applies only to the substance, mixture or article being applied for. All changes that are relevant from a health and environmental point of view must be reported to FIHM. If the applicant is of the opinion that there is a need for additional time for the exemption, a new updated notification for exemption must be submitted to FIHM. If the new updated notification is not submitted within the stipulated period, the exemption is terminated.

When applying for a defence exemption with reference to part 1 in § 24 in regulation (2008:245), the form “Blankett ansökan om dispens REACH CLP” (in Swedish) or “Exemption application form REACH CLP” (in English) must be used. The applicant shall provide the information requested in the form, depending on the scope of the application. The forms can be downloaded at:
https://www.forsvarsmakten.se/sv/om-forsvarsmakten/dokument/blanketter-fihm

The following procedure applies to an application with reference to abovementioned part 2 in § 24 in regulation (2008:245):

The application is to be sent (3 copies) by a legal entity (e.g. a company) directly to FIHM. The procedure that follows is similar to the procedure described for part 1 in § 24 in regulation (2008:245). FIHM may consult with the defence authorities regarding the applicant´s claims related to Swedish defence interests. The decision is communicated by FIHM to the legal entity making the request for exemption. When applying for a defence exemption with reference to part 1 in § 24 in regulation (2008:245), the form “Blankett ansökan om dispens REACH CLP” (in Swedish) or “Exemption application form REACH CLP” (in English) must be used.

The applicant shall provide the information requested in the form, relevant for an application for exemption from article 33.1 in the Reach regulation.

The forms can be downloaded at: https://www.forsvarsmakten.se/sv/om-forsvarsmakten/dokument/blanketter-fihm

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

There is no limit of the provisions in REACH from which the defence authorities can apply for an exemption, but every application must be assessed on a case-to-case basis.
Some additional remarks:

  • On Article 33 notifications in the supply chain: if it is necessary with regard to Swedish defence interests and if the exemption relates to articles (as defined in REACH art 3(3)) that are intended to be used for military purposes
  • On Article 66(1) notifications: if it is necessary with regard to the interests of the total defence and if the exemption refers to Swedish defence authorities
  • On Registration: if it is necessary with regard to the interests of the total defence and if the exemption refers to Swedish defence authorities
  • On Authorisation: if it is necessary with regard to the interests of the total defence and if the exemption refers to Swedish defence authorities
  • On Restriction: if it is necessary with regard to the interests of the total defence and if the exemption refers to Swedish defence authorities
  • 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

Applicants are required to fill in a specific formal document/template or form when they apply for a defence exemption.

The template for application for a defence exemption (see template ”Blankett ansökan om dispens REACH CLP” (in Swedish) or “Exemption application form REACH CLP” (in English)) is available at: https://www.forsvarsmakten.se/sv/om-forsvarsmakten/dokument/blanketter-fihm/.

The template is currently available only in the national language (Swedish) but a translation to English will be available by September 2023.

2.4. Charges/Fees

No charges/fees are foreseen to be paid by stakeholders to the Ministry of Defence.

2.5. Decision-making process

Applications for exemption will be handled jointly by the Inspectorate for Medicine and Environmental Health (FIHM) and the Swedish Chemicals Agency which ensures a competent review of the applications both from a chemical and military point of view.

Exemptions will be reviewed after a pre-determined period of time.

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 example 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.

Within 3 months every impact on human health and the environment has to be communicated. If the legislation changes during the period of validity, the applicant is obliged to (re)justify the requirements.

2.7. Extension

It is possible to provide an extension to the initial validity period of the defence exemption.

This can be done through a simpler variant of the original application including the reason why the extension is needed. It is to be stated why this was not specified from the beginning in the original application.

The extension can only be provided for a short time, maximum 2 years.

3. Description of National Safety and Traceability Measures

The Swedish procedure for granting exemption will contain standards as good as those in the REACH regulation, as far as reasonably practicable.

Applications for exemption will be handled jointly by the Inspectorate for Medicine and Environmental Health (FIHM) and the Swedish Chemicals Agency, which ensure a competent review of the applications both from a chemical and military points of view.

Exemptions will be reviewed after a pre-determined period of time.

A Chemical Safety Assessment (CSA) is required at times. The application must follow the EDA Framework for applying for a defence exemption.

The governmental agency that reviews the CSA is the Swedish Chemicals Agency, when applicable.

A Chemical Safety Report (CSR), as in the REACH authorisation process, is not likely to be requested.

4. National Bodies Involved

Försvarsinspektören för hälsa och miljö (FIHM) (The Inspectorate for Medicine and Environmental Health)

Kemikalieinspektionen (KemI) (Swedish Chemicals Agency)

Försvarets materielverk (FMV) (Swedish Defence Materiel Administration)

Försvarsmakten (Swedish Armed Forces)

Fortifikationsverket (Swedish Fortifications Agency)

Försvarets radioanstalt (FRA) (National Defence Radio Establishment)

Totalförsvarets forskningsinstitut (FOI) (Swedish Defence Research Agency)

5. Where to File an Application

When applying for a defence exemption with reference to part 1 in § 24 in regulation (2008:245), the form “Blankett ansökan om dispens REACH CLP” (in Swedish) or “Exemption application form REACH CLP” (in English) must be used.

The forms can be downloaded at:
https://www.forsvarsmakten.se/sv/om-forsvarsmakten/dokument/blanketter-fihm

An application with reference to part 1 in § 24 in regulation (2008:245) shall be sent to the relevant defence agency below which then acts as the applicant and file the application to the Inspectorate for Medicine and Environmental Health:
Försvarets materielverk (FMV) (Swedish Defence Materiel Administration)
registrator@fmv.se
+4687824000

Försvarsmakten (Swedish Armed Forces)
exp-hkv@mil.se
+4687887500

Fortifikationsverket (Swedish Fortifications Agency)
fortv@fortv.se
+46104444000

Försvarets radioanstalt (FRA) (National Defence Radio Establishment)
fra@fra.se
+4684714600

Totalförsvarets forskningsinstitut (FOI) (Swedish Defence Research Agency) registrator@foi.se
+46855503000
+46855503000

An application with reference to part 2 in § 24 in regulation (2008:245) shall be filed directly by the legal entity (the applicant) to the Inspectorate for Medicine and Environmental Health:
Försvarsinspektören för hälsa och miljö (FIHM) (Inspectorate for Medicine and Environmental Health)
exp-fihm@mil.se
+4687887500

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

N/A.

7. Number of Exemptions Granted

One (1) defence exceptions have been granted to date.

8. Contact Info

Försvarsinspektören för hälsa och miljö (FIHM) (Inspectorate for Medicine and Environmental Health)
exp-fihm@mil.se
+468 788 75 00

Försvarets materielverk (FMV) (Swedish Defence Materiel Administration)
registrator@fmv.se
+4687824000

Försvarsmakten (Swedish Armed Forces)
exp-hkv@mil.se
+4687887500

Fortifikationsverket (Swedish Fortifications Agency)
fortv@fortv.se
+46104444000

Försvarets radioanstalt (FRA) (National Defence Radio Establishment)
fra@fra.se
+4684714600

Totalförsvarets forskningsinstitut (FOI) (Swedish Defence Research Agency) registrator@foi.se
+46855503000+46855503000

9. Links to national websites

https://www.forsvarsmakten.se/sv/organisation/hogkvarteret/forsvarsinspektoren-for-halsa-och-miljo/
www.kemi.se
www.fmv.se
www.fortifikationsverket.se
www.foi.se

 

Last Update: 14 November, 2023