1. Legal Basis
REACH Regulation exemptions can be granted under Article 1 (2) of the Act No. 67/2010 of 2 February 2010 on conditions applicable to the placing on the market of chemical substances and chemical mixtures, amending certain acts (Chemicals Act).
The following regulations are implemented into the state law of the Slovak Republic by the Act No. 67/2010 Coll. (EN version on: http://www.mhsr.sk/legislation/ 126351s):
- Regulation (EC) No. 1907/2006 of the European Parliament and the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
- Regulation (EC) No 648/2004 of the European Parliament and the Council of 31 March 2004 on detergents,
- Regulation (EC) No. 689/2008 of the European Parliament and the Council of concerning the export and import of dangerous chemicals,
- Regulation (EC) No. 1272/2008 of the European Parliament and the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (CLP).
2. Description of National Procedure
2.1. Overview
The Ministry of Economy (MoE) of the Slovak Republic shall grant exemptions from Article 2 (3) of the REACH Regulation in exceptional cases: where necessary in the interest of state defence, and following the application of the Ministry of Defence (MoD) of the Slovak Republic.
State Administration in the sphere of classification, labelling, packaging and placing on the market of substances, substances contained in mixtures and substances in articles and concerning conditions of their use shall be carried out by:
- The Ministry of Economy of the Slovak Republic, the Centre for Chemical Substances and Preparations
- The Ministry of Health of the Slovak Republic
- The Ministry of Environment of the Slovak Republic
- The Ministry of Agricultural and Rural Development of the Slovak Republic
Inspection bodies are:
- The Slovak Trade Inspection and Inspectorates
- The Public Health Authority, Regional Public Health Authorities and Regional Health Authority seated in Banská Bystrica
- The Slovak Environmental Inspection and Inspectorates
- The National Labour Inspectorate and Labour Inspectorates
The Central Mining Authority and District Mining Authorities
Custom Authorities - The Ministry of Defence of the Slovak Republic
The Ministry of Defence of the Slovak Republic shall:
- Supervise compliance with the provisions of the present Act within armed forces and by legal persons falling within its constituent competences having been granted derogation from the present Act;
- Provide the Ministry of Economy of the Slovak Republic, Centre for Chemical Substances and Preparations with the information whenever it finds the use of substances, mixtures or articles within armed forces and by legal persons falling within its constituent competences pose direct risk to human health which is not adequately controlled;
- Submit to the Ministry of Economy of the Slovak Republic a summary report concerning results of inspections conducted within armed forces and legal persons falling within its constituent competences as well as concerning remedial action and fines imposed over the respective calendar year as top the 31 March of the next year.
The Ministry of Economy of the Slovak Republic may, on the basis of the application of the Ministry of Defence of the Slovak Republic, grant exemptions from provisions of special regulations (REACH and CLP) for substances, substances contained in mixtures or substances in articles, when they are necessary for the armed forces to safeguard state defence.
2.2. Scope
Stakeholders can apply for a defence exemption through any part of the REACH Regulation.
It is 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
Applicants are not required to pay any charges/fees to the Ministry of Defence when applying for a defence exemption.
2.5. Decision-making process
The exemptions are assumed to be granted only for the Ministry of Defence of the Slovak Republic. It is the exclusive responsibility of the Ministry of Defence of the Slovak Republic to determine what is in the interest of state defence and to ensure that the institute of exemptions will not be misused. Having an exemption granted, the Ministry of Defence of the Slovak Republic takes responsibility for adequate level of protection associated with using such substances and mixtures and eventually articles containing them.
The Act No. 67/2010 Coll. does not specify conditions under which the Ministry of Economy of the Slovak Republic can grant exemptions. It results from the specific position and tasks fulfilled by the Ministry of Defence of the Slovak Republic. Granting an exemption does not relieve the Ministry of Defence of the Slovak Republic from its responsibility for securing proper public health protection and environmental protection using analogical processes and standards at national level such as those established by the REACH Regulation, CLP Regulation and related directives. The Ministry of Economy of the Slovak Republic lays down the conditions in its decision on granting exemptions.
2.6. Validity period
Validity duration is decided on a case-by-case basis, for example similar to the authorisation process (4, 7 or 12 years).
This time limitation shall allow the Ministry of Economy of the Slovak Republic, as an administrative body, to perform an update of the decision on permission of an exemption on the basis of current legal status, new requirements for harmonisation of national exemptions and their mutual recognition among EU member states.
After an exemption has been granted and during its validity period, the applicant to which the exemption has been granted is not required to (re)justify the requirements.
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
The National Safeguard Measures mirror the Chemical Code and measures imposed by the REACH Regulation.
A Chemical Safety Assessment (CSA) is never required.
Exemptions granted so far were decided before the adoption of the EDA Code of conduct on REACH defence exemptions (before 2015).
4. National Bodies Involved
- The Ministry of Economy of the Slovak Republic
- The Ministry of Health of the Slovak Republic
- The Ministry of Environment of the Slovak Republic
- The Ministry of Agriculture and Rural Development of the Slovak Republic
- The Ministry of Defence of the Slovak Republic
The setup of the defence exemption procedure is led by the Ministry of Defence of the Slovak Republic in connection with the Ministry of Economy of the Slovak Republic.
5. Where to File an Application
It is recommended to have a preliminary contact with:
Director General – National Armaments Director
Ministry of Defence
Modernization and Support Department
Kutuzovova 8
832 47 Bratislava
Slovakia
(phone: +421 960 317 572, fax: +421 960 312 584 )
6. Conditions/Procedures for Acknowledgment/Recognition of Foreign Defence Exemptions
Substances and mixtures should be, wherever possible, manufactured, imported and used in the defence department in accordance with the REACH and CLP Regulations. In cases that are inevitable for the purposes of defence, which must and can be justified only by the Ministry of Defence of the Slovak Republic, the Ministry of Economy of the Slovak Republic shall grant exemption.
In case the Ministry of Defence of the Slovak Republic would use a substance or a mixture for which another state has granted exemption, the Ministry of Defence of the Slovak Republic following the current legislation will ask the Ministry of Economy of the Slovak Republic for granting an exemption. Final decision on granting of an exemption is taken by the Ministry of Economy of the Slovak Republic.
7. Number of Exemptions Granted
To date, 2 defence exemptions have been granted.
8. Contact Info
Ms. Martina KUROVA
Regulatory officer
Ministry of Economy
Centre for Chemical Substances and Preparations
Mlynské nivy 44/a | 827 15 Bratislava 212
00421 2 4854 4505
martina.kurova@mhsr.sk
chemicals@mhsr.sk
9. Links to national websites
Slovak MoD website: http://www.mod.gov.sk
Slovak MoE website: http://www.economy.gov.sk
Last Update: 14 November, 2023