1. Legal Basis
The Implementing Act of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of the European Union on the Registration, Evaluation, Authorization and Restriction of Chemicals, May 9th 2008 (Croatian only) can be found here: https://narodne-novine.nn.hr/clanci/sluzbeni/2008_05_53_1782.html
The Act on Amendments to the Implementing Act of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of the European Union on the Registration, Evaluation, Authorization and Restriction of Chemicals, February 13th2013 (Croatian only) can be found here: https://narodne-novine.nn.hr/clanci/sluzbeni/2013_02_18_295.html
The Act on Amendments to the Act on the Implementation of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of the European Union on the Registration, Evaluation, Authorization and Restriction of Chemicals, December 20th 2018 (Croatian only) can be found here: https://narodne-novine.nn.hr/clanci/sluzbeni/2018_12_115_2257.html
2. Description of National Procedure
2.1. Overview
The National Procedure follows the same language as described in the REACH Regulation documents directly implemented through the national legal basis. Procedure is the same as described in: https://echa.europa.eu/support/registration
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
During the application evaluation, it will be decided whether the exemption from procedure under b), c), d), e) is applicable, depending on the substance, use, type of the 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
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
2.6. Validity period
There is no specific validity duration when the exemption is granted. Duration of validity is decided on a case-by-case basis, similarly to the authorisation process.
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 annually.
2.7. Extension
There is no possibility to provide an extension to the initial validity period of the defence exemption.
3. Description of National Safety and Traceability Measures\
Safeguarding and Inspection supervision over the implementation of Regulation 1907/2006 / EC is carried out by sanitary inspectors in accordance with the regulations governing the scope of work and powers of Sanitary Inspection (of the Ministry of Health and Local Government) and supervision of hazardous chemicals. Administrative oversight over the implementation of Regulation 1907/2006 / EC and this Act is carried out by the Ministry of Health.
A Chemical Safety Assessment (CSA) is not required. However, on a case-by-case basis, it can be required to provide Chemical Safety Report (CSR). In that case, the Croatian Institute for Public Health would be the body to review the CSR.
4. National Bodies Involved
The Ministry of Health of the Republic of Croatia is the responsible body in Republic of Croatia for all REACH matters, including defence exemptions issues. The Croatian Institute of Public Health holds a broad supporting role. In addition, the Ministry of Defence of the Republic of Croatia provides information for the Ministry of Health, if necessary and within the scope of defence exemption issues on case-by-case basis.
5. Where to File an Application
The Ministry of Health in accordance with the Act on the Implementation of Regulation (EC) Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals is to assist industry in the implementation of this Regulation.
Procedure is explained on the following website: https://echa.europa.eu/documents/10162/23036412/registration_en.pdf
Applications should be filed through the Ministry of Health point of contact: helpdesk-reach@miz.hr
6. Conditions/Procedures for Acknowledgment/Recognition of Foreign Defence Exemptions
The Ministry of Health of the Republic of Croatia is the responsible body in Republic of Croatia for all REACH matters, including foreign defence exemptions and follows the same conditions and procedures as non-defence exemptions.
7. Number of Exemptions Granted
No defence exemption has been granted to date.
8. Contact Info
Ministry of Health of the Republic of Croatia
Address: Ksaver 200a, 10000 City of Zagreb, Republic of Croatia
Phone: +385 1 46 07 555
Fax: +385 1 46 77 076; +385 1 4607 631
E-mail: helpdesk-reach@miz.hr
Croatian Institute of Public Health
Toxicology Department
Address: Borongajska 83g, 10000 City of Zagreb, Republic of Croatia
Phone: +385 1 46 86 910; +385 1 46 86 919; +385 1 46 33 070
Fax: +385 1 46 41 368
E-mail: hzt@hzt.hr; info@hzjz.hr
9. Links to national websites
Ministry of Health of the Republic of Croatia (Croatian Only)
https://zdravlje.gov.hr/djelokrug-1297/sanitarna-inspekcija/kemikalije-i-biocidni-pripravci-1357/kemikalije-1785/reach-1795/1795
Croatian Institute of Public Health
http://hzt.hr/helpdesk/helpdesk-za-reach.html (Croatian Only)
http://hzt.hr/upit/index.php (Submit a question)
https://www.hzjz.hr/en/ (English)