Informative Notice
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Production of hazardous chemicals
Hazardous chemicals are substances or mixtures which meet the criteria for physical hazards, health hazards or environmental hazards as defined in Annex I of Regulation 1272/2008/EC of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (L 353 of 31 December 2008, page 1).
Legal and natural entities who produce hazardous chemicals in the Republic of Slovenia must have authorisation for producing hazardous chemicals.
Applies for SKD:
- Wholesale of chemical products G46.750
Conditions
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Legal and natural persons who produce hazardous chemicals in the Republic of Slovenia must have a permit to perform the activity of production of hazardous chemicals.
The permit is issued on the basis of the application and the submitted evidence of compliance.
The body responsible for chemicals shall keep a list of legal and natural persons who have obtained a permit for the production of hazardous chemicals.
The activity of production of hazardous chemicals may be performed by legal and natural persons who demonstrate to the body responsible for chemicals:
- that they have their registered office in the Republic of Slovenia or one of the Member States of the European Union, whereby the latter must have a branch in the Republic of Slovenia, or a natural or legal person authorized to act on their behalf and for their account;
- that, depending on the type and scope of activities, they have professionally qualified persons with the knowledge that enables them to perform their obligations and meet the requirements in accordance with this Act;
- to implement specific technical or organizational measures for the marketing, production, storage or use of dangerous chemicals that are necessary to protect human health and the environment;
- meet the requirements for facilities and the requirements for the scheduling and protection of individual groups of chemicals;
- that they have not been deprived of a license to carry out activities on the basis of a final court judgment, which shows that the holder of the license, who is a natural person, intentionally misused the license to produce or trade special groups of chemicals regulated by law on Strategic Goods of Special Importance for Safety and Health and the Drug Precursors Act.
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Legal and natural persons who produce hazardous chemicals in the Republic of Slovenia must have a permit to perform the activity of production of hazardous chemicals.
The permit is issued on the basis of the application and the submitted evidence of compliance.
A single authorization may be granted for the one-off activity of production of hazardous chemicals for limited quantities of hazardous chemicals intended for a limited number of professional end-users for a specific purpose, provided that the quantity of such chemical is justified and in accordance with the intended use. If the applicant is a legal or natural person who is not established in the Republic of Slovenia, the II. point of the form also for a branch or proxy.
A single authorization cannot be obtained for chemicals intended for general use.
The body responsible for chemicals shall keep a list of legal and natural persons who have obtained a permit for the production of hazardous chemicals.
The activity of production of hazardous chemicals may be performed by legal and natural persons who demonstrate to the body responsible for chemicals:
- that they have their registered office in the Republic of Slovenia or one of the Member States of the European Union, whereby the latter must have a branch in the Republic of Slovenia, or a natural or legal person authorized to act on their behalf and for their account;
- that, depending on the type and scope of activities, they have professionally qualified persons with the knowledge that enables them to perform their obligations and meet the requirements in accordance with this Act;
- to implement specific technical or organizational measures for the marketing, production, storage, or use of dangerous chemicals necessary for the protection of human health and the environment;
- meet the requirements for facilities and the requirements for the scheduling and protection of individual groups of chemicals;
- that they have not been deprived of a license to carry out activities on the basis of a final court judgment, which shows that the license holder, who is a natural person, intentionally misused the license to produce or trade special groups of chemicals regulated by law on Strategic Goods of Special Importance for Safety and Health and the Drug Precursors Act.
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Legal and natural persons who meet the prescribed conditions for the production, storage or trade of chemicals and all those who use or handle them must ensure chemical safety.
A legal and natural person who manufactures or places hazardous chemicals on the market must:
- provide instructions for the safe use of the hazardous chemical;
- take care of waste supply in accordance with waste regulations;
- be liable in accordance with special regulations for any damage that may occur during their production or marketing.
All users of hazardous chemicals must be reminded of the hazardous properties of the chemical when purchasing the chemical, and at their request, appropriate explanations must be provided on the proper use of the chemical, measures to protect health and the environment and the handling of their residues.
Legal basis
- Chemicals Act (ZKem)
- Rules on user information, register and the specific requirements for trade in dangerous chemicals
- REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (E (2008/1272)
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No later than on the occasion of the first transfer of the chemical to third parties or upon the first entry of the chemical to the Republic of Slovenia, the person liable for every hazardous chemical which as per its characteristics is classified as hazardous in accordance with Regulation (EC) No 1272/2008 must submit to the competent authority the following information:
- general data on the applicant,
- trade name of the chemical,
- labelling of the chemical, safety data sheet and
- chemical composition.
No later than by 31 March of the following year after the first transfer of the hazardous chemical to third parties or upon the first entry of the chemical to the Republic of Slovenia, the person liable must submit to the competent authority further information:
- the code as per the Customs Tariff nomenclature;
- whether the chemical is a substance or a compound;
- whether the chemical is being produced by the person liable or imported to the Republic of Slovenia;
- is the chemical partly or fully intended for general use;
- Nomenclature of Economic Activities (NACE) and
- the category of the chemical.
The person liable must inform the competent authority of any changes to the aforementioned data on chemicals in the preceding year no later than by 31 March.
The person liable who removes a chemical from the market in the Republic of Slovenia or who no longer imports the chemical into the Republic of Slovenia must report this accordingly to the competent authority no later than by 31 March of the following year and must also provide the date of the removal or the date of the cessation of entry of the chemical. The competent authority confirms the deletion from the list of chemicals.
The person liable reports directly by entering the relevant data in an ISK web application.
Legal basis
Competent Authority
Ministry of Health, Chemicals Office of the Republic of Slovenia
Ajdovščina 4
1000 Ljubljana -
In 2017, the Commission issued Regulation 2017/542 (this is a new Annex VIII of the CLP Regulation) which enabled the harmonization of procedures for the submission of information on hazardous mixtures by importers and downstream users of hazardous mixtures.
The regulation allows better response to acute human poisoning and development of preventive measures as well as equalizes the level of protection of users of hazardous mixtures in all Member States.
The obligation to provide harmonized information is introduced gradually from 1 January 2021 to 1 January 2025.
In the Republic of Slovenia, information on hazardous mixtures is submitted to the Chemicals Office of the Republic of Slovenia and Centre for Clinical Toxicology and Pharmacology at the University Medical Centre Ljubljana as designated national authorities.
All submitters from the Republic of Slovenia and other EU Member States must submit the required information through the ECHA Submission Portal.
Administrator of Legislation
Ministry of Health, Chemicals Office of the Republic of Slovenia
Ajdovščina 4
1000 Ljubljana -
Legal and natural persons who manufacture, store or place dangerous chemicals on the market must provide conditions that prevent or reduce the danger to humans and the environment.
Legal basis
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Legal and natural persons who manufacture or place on the market hazardous chemicals must ensure that hazardous chemicals are replaced with less hazardous substitutes.
Legal basis
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Manufacturers and legal and natural persons who place hazardous chemicals on the market must ensure the collection, proper storage and safe disposal of their residues and packaging in accordance with waste management regulations.
Users of hazardous chemicals must dispose of their residues and packaging in accordance with waste regulations.
Legal basis
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Since 1 June 2015, as in other EU member states, the Republic of Slovenia has been using a globally unified system for the classification, labelling and packaging of hazardous chemicals, i.e., GHS (Globally Harmonized System). In the EU, we adopted the GHS document, which has been being drafted and supplemented under the auspices of the UN in Geneva since 2001, in the form of Regulation No. 1272/2008 of the European Parliament and of the Council. CLP Regulation (CLP- Classification, Labelling and Packaging of hazardous chemicals).
The main goals of the GHS or. CLPs are: to identify the hazardous properties of a chemical, to provide this information to the user through a label and safety data sheet, thus enabling more comprehensive, rational and responsible use at both the local and global level.
CLP Regulation (Regulation (EC) No 1272/2008)
1. Unofficial clean copy
On the website of the European Chemicals Agency (ECHA) you can find an unofficial clean copy or consolidated version of the CLP Regulation:
- unofficial clean copy of the CLP regulation (in Slovene) - in certain parts of the text there was an error in quoting warning words. Proper citation is DANGEROUS and CAUTION!
- unofficial clear copy of the CLP Regulation (in English)
2. Other more detailed information
- Classification and Labelling Inventory: is an electronic database maintained by ECHA containing information on the classification and labelling of notified and registered substances provided by manufacturers and importers. It also contains a list of official, harmonized classifications i.e., the list set out in Annex VI of CLP Regulation. These are clearly marked in the inventory (in blue) and must be observed. The inventory is regularly updated and can be found on the ECHA website.
3. Amendments to the CLP Regulation
The Regulation is regularly amended mainly due to changes and amendments to the GHS document and due to changes in the EU list of harmonized classifications and labelling of substances. More information can be found on the ECHA website.
From 1 January 2021, the provisions of the Regulation apply to the implementation of Article 45 of the CLP Regulation (Regulation (EC) No 542/2017).
This amendment adds a new Annex VIII to the CLP Regulation, which regulates the submission of information on hazardous mixtures to designated national authorities in Slovenia by the Office of Chemicals of the Republic of Slovenia.
Legal basis
- REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (E (2008/1272)
- Chemicals Act (ZKem)
- Rules on the classification, packaging and labelling of dangerous substances
- Rules on the classification, packaging and labelling of dangerous preparations
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1. Any advertising of a substance classified as dangerous shall indicate the hazard classes or categories concerned.
2. Any advertising of a mixture classified as hazardous or subject to Article 25 (6) of Regulation 1272/2008 / EC, which allows the general user to conclude a purchase contract without first seeing the label, shall indicate the type or types of hazards, which are listed on the label.
Legal basis
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REACH stands for Registration, Evaluation, Authorization and Prohibition of Chemicals. It is the primary chemical legislation that aims to protect health and the environment while increasing competitiveness. REACH makes it possible to obtain information on chemicals and the evaluation of substances carried out by Member States, making it possible to determine whether further action, such as the authorization or prohibition of a substance, needs to be taken for a given substance.
We can also find in REACH that an additional measure in other legislation, such as e.g., environmental legislation or legislation for the worker in the workplace. Waste legislation is also an important junction with REACH. When waste ceases to be waste, it needs to be registered in REACH. Guidance is available on the European Chemicals Agency (ECHA) website for all details and clarifications of the legislation.
1. Registration
Registration is the process by which a taxable person obtains a registration number issued by the European Chemicals Agency (hereinafter: ECHA) and allows him to place a substance on the market in the European Union.
The registration of a substance under REACH follows from the "no market without data" provision. It is required for substances classified as dangerous as well as for those not classified as dangerous, for quantities greater than or equal to one tonne per year per manufacturer or importer. The substance is always registered as such or contained in the preparation. Registrants are required to obtain the required information on substances set out in the REACH Annexes and submit it to ECHA. The data required are different and depend on the tonnage band, which are as follows: 10-100 tonnes, 100-1000 tonnes and over 1000 tonnes.
The registration requirement is that manufacturers and importers of substances must gather information on the effects of substances on the environment and health, assess the risks arising from the uses of their substances and ensure that the risks are properly controlled. In order to ensure this, manufacturers and importers must submit a technical dossier (for substances in quantities of 1 tonne or more per year) and, in addition, a chemical safety report (for substances in quantities of 10 tonnes or more per year, if the substance is also classified in accordance with the Regulation on Classification, Labelling and Packaging). As a rule, one substance - one registration - is valid to prevent animal testing. This means that for each substance there is a lead registrant who has already provided data for the substance for the whole group of registrants and so it is necessary to check or inquire with ECHA whether the substance is already registered before possible registration. Then it is necessary to agree with the lead registrant on the payment of data sharing (note: before the adoption of the new implementing regulation of the European Commission governing data sharing).
More information on the registration process
Conditions and evidence
- Technical documentation
The technical dossier contains information on the properties and classification of the substance and on the uses and guidelines for safe use. The information needed to determine the properties of a substance varies according to the quantity of the substance produced or imported. A larger amount of a substance requires more information. REACH also provides for the sharing of data between registrants in order to gather the necessary information.
- Submission of the registration dossier to ECHA
All registration dossiers must be submitted to ECHA. This needs to be done using REACH-IT. More information and access to REACH-IT can be found on the ECHA website.
The registration dossier must be submitted in IUCLID (International Uniform Chemical Information Database) format. IUCLID is a software tool designed for companies to store data on chemicals and prepare registration dossiers. The registrants have no obligation to use IUCLID but must submit their registration in IUCLID format.
- Obtaining a registration number
The registration is completed when ECHA receives payment of the registration fee. The registration number is then sent to the registrant. Registration fees are set out in Commission Regulation (EC) No 340/2008.
- Chemical safety report
A chemical safety report is a chemical safety assessment dossier for a registrant substance (or substances concerned if a chemical safety report has been prepared for a category of substances with similar properties). Annex I of REACH sets out the general provisions for substance evaluation and chemical safety reporting. The information requirements are set out in more detail in the Guidance on information requirements and chemical safety assessment. You can use the CHESAR tool to prepare a chemical safety assessment and a chemical safety report.
- Exposure scenario
Exposure scenarios should be prepared if the substance is manufactured or imported in quantities of 10 tonnes or more per manufacturer or importer per year and classified as hazardous or as PBT/vPvB.
An exposure scenario is a set of conditions that describe how a substance (as such, in preparation or article) is produced or used during its life cycle and how the manufacturer, importer or downstream user controls or recommends control of human and environmental exposure.
Exposure scenarios should be included in the chemical safety report and communicated to downstream users in the form of annexes to the safety data sheets.
Exposure scenarios are also a tool for communicating operating conditions and supply chain risk management conditions, as the relevant exposure scenarios are attached to safety data sheets that are forwarded to downstream users and distributors.
Practical examples of exposure scenarios
Legal protection
- Remedy: Appeal to the Board of Appeal. For certain ECHA decisions, affected parties can turn to the Board of Appeal. The letter is sent to the Board of Appeal (e-mail: appeal@echa.europa.eu)
- Competent authority: European Chemicals Agency (ECHA)
2. Authorization
The aim of the authorization process is to ensure that substances of very high concern (SVHCs) are gradually replaced by less hazardous substances or technologies where technically and economically feasible alternatives are available. Substances of very high concern are mainly substances which are:
- Carcinogenic, mutagenic, toxic for reproduction (CMR) Cat 1 and 2
- persistent, bioaccumulative and toxic (PBT)
- very persistent and very bioaccumulative (vPvB)
- substances that present a similar level of concern
Substances that are identified as SVHC substances due to their hazardous properties are included in the Candidate List, which is updated each time it is updated on the website of the European Chemicals Agency (ECHA).
Conditions and evidence
Public consultations in the process of authorization of substances:
- Substances on the candidate list are further prioritized and proposed by the Commission for inclusion in Annex XIV of the REACH Regulation and thus become subject to authorization. Substances included in Annex XIV may be used without authorization until the date specified in that Annex ("sunset" date). If the user needs this substance after the sunset date, he/she must ensure that the authorization application is submitted to ECHA in a timely manner. The deadline for submitting an authorization is also set out in the Annex itself. The application may be submitted by the manufacturer of the substance or by the downstream user. Authorization for an individual applicant (or consortium) is accepted/rejected by the European Commission.
- Public consultations are important in the process, where companies, as well as others, can comment and/or provide the information they have at their disposal.
- A public consultation in the three-step authorization process is crucial for manufacturers and users of “relevant” substances to recognize in a timely manner that a substance or chemical relevant to them may become subject to authorization and to be directly involved. in the process. It takes place through the ECHA website, where individual companies and others can comment or submit studies and other information at their disposal that is relevant to the preparation of opinions on a particular substance.
The Office of the Republic of Slovenia for Chemicals, as the competent authority for the implementation of the REACH Regulation, invites all those who are concerned with a particular substance and need the authorization to use the substance to be actively involved in the process.
Public discussion in step 1):
During the public consultation for the identification of substances of very high concern (SVHC substances), ECHA is most welcome to comment on the identity of the substance itself, such as e.g., intrinsic properties of the substance that are crucial to justify identification. These are all scientific findings and possible studies that would challenge the fact that it is an SVHC substance.
In this step, other comments are also possible, such as e.g., regarding use, but will be considered in the next steps of the authorization process.
Public discussion in step 2):
In this part of the public debate, the European Chemical Agency is particularly welcome to comment on the transitional provisions and those uses that could be exempted from authorization requirements. When proposing such exceptions, the conditions laid down in the second paragraph of Article 58 shall be taken into account; this is, for example, that there is already specific EU legislation (not just national) that ensures that the risk arising from certain legislation is already adequately controlled.
Public discussion in step 3):
For substances included in the authorization list (Annex XIV of REACH), manufacturers, importers and downstream users must submit an application to ECHA if they wish to continue using after the date set out in Annex XIV. This third step of the application for authorization involves an 8-week public discussion on alternative substances or technologies for the use of substances subject to authorization for which an application for authorization has been submitted to ECHA.
Applications for authorization shall be submitted to the European Chemicals Agency. At the end of the authorization process is the European Commission, which decides to approve or refuse to obtain an authorization.
Legal basis