Informative Notice
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Wholesale of hazardous chemicals and chemical products
The commercial activity is performed in sales outlets or outside them, in accordance with the prescribed conditions.
In order to carry out a commercial activity, the minimum technical conditions relating to:
- space, equipment and devices in the store,
- the exterior of the store,
- method, equipment and devices for the sale of goods outside stores,
- method, equipment and devices in a specially arranged space in the wholesale store.
Hazardous chemicals are substances or mixtures that meet the criteria for physical, health or environmental hazards defined in Annex I of Regulation 1272/2008/EC 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 1907/2006 / EC (OJ L 353, 31.12.2008, p. 1).
Legal and natural persons who trade in hazardous chemicals in the Republic of Slovenia must meet the prescribed conditions and be licensed to engage in the activity of trade in hazardous chemicals.
In addition to the conditions below, see the conditions for the manufacture of other chemical products.
Applies for SKD:
- Wholesale of chemical products G46.750
Conditions
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Legal and natural persons who trade in dangerous chemicals in the Republic of Slovenia must be licensed to trade in dangerous 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 marketing authorization for hazardous chemicals.
The activity of trade in 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 holder of the license, who is a natural person, intentionally misused the license to manufacture or trade special groups of chemicals regulated by the strategic goods of special importance to safety and health and the law on drug precursors.
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Legal and natural persons who trade in dangerous chemicals in the Republic of Slovenia must be licensed to trade in dangerous chemicals.
The permit is issued on the basis of the application and the submitted evidence of compliance.
A single authorization may be granted for a single trade in 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 marketing authorization for hazardous chemicals.
The activity of trade in dangerous 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 judgment of a court which shows that the holder of an authorization who is a natural person has intentionally misused the authorization to manufacture or trade special groups of chemicals regulated by the Strategic Goods Act of special importance for safety and health and the Act on precursors for illicit drugs.
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Legal and natural persons using hazardous chemicals in the Republic of Slovenia, which are classified as:
- acutely toxic (oral, dermal, inhalation), hazard categories 1, 2 and 3,
- germ cell mutagens, hazard categories 1A and 1B,
- carcinogenic, hazard categories 1A and 1B,
- toxic for reproduction, hazard categories 1A and 1B,
- specific target organ toxicity for single exposure, hazard category 1,
- specific target organ toxicity on repeated exposure, hazard categories 1
they must be authorized to carry out activities with 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 marketing authorization for hazardous chemicals.
The activity of using 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 holder of the license, who is a natural person, intentionally misused the license to manufacture or trade special groups of chemicals regulated by the strategic goods of special importance to safety and health and the law on drug precursors.
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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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Legal and natural persons who place dangerous chemicals on the market as objects of general use, which are marked as:
- acutely toxic hazard categories 1, 2 and 3 (H300, H310, H330, H301, H311, H331),
- germ cell mutagens, hazard categories 1A and 1B (H340),
- carcinogenic, hazard categories 1A and 1B (H350),
- toxic for reproduction, hazard categories 1A and 1B (H360, H361),
- Specific target organ toxicity for single exposure, hazard category 1 (H370),
- Specific target organ toxicity on repeated exposure, hazard category 1 (H372),
they must keep records of the release of these hazardous chemicals to users who are not chemical manufacturers in accordance with regulations.
The issue record must contain the following information:
- information on the chemical (name or trade name, quantity issued, expiry date, if any);
- the purpose of use when this is not evident in itself;
- data on the recipient (name, surname and year of birth or his / her unique identification number, address);
- Handwritten signature of the recipient and the person who issued the chemical.
The data from the records shall be kept by the legal and natural persons referred to in the previous paragraph for at least five years and must be forwarded to the body responsible for chemicals upon request.
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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Chemicals classified in accordance with Regulation 1272/2008 / EC as:
- acutely toxic (oral, dermal, inhalation), hazard categories 1, 2 and 3,
- germ cell mutagens, hazard categories 1A and 1B,
- carcinogenic, hazard categories 1A and 1B,
- toxic for reproduction, hazard categories 1A and 1B,
- Specific target organ toxicity for single exposure, hazard category 1,
- Specific target organ toxicity on repeated exposure, hazard categories 1
and placed on the market as objects of general use, it is prohibited to issue to persons under 18 years of age.
The user must present a valid identity document upon receipt of the chemical.
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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A trader must ensure the recording of business events regarding the condition of goods in accordance with the Slovenian Accounting Standards or International Financial Reporting Standards.
At the point of sale, the trader must provide the competent inspection authorities with the following information on the condition of goods:
- number and date of the entry document;
- name of the supplier;
- number and date of the supplier’s document;
- name, unit of measure and quantity of goods;
- the sales price of goods;
- information on changes to the sales price of goods.
Legal basis
Administrator of Legislation
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A trader determines the opening times of the outlet in accordance with his or her business decision and considering the needs of consumers. The outlet must operate in accordance with the published schedule of working hours.
When determining working hours, the trader must consider the number of employees in the outlet and their rights, obligations and responsibilities arising from the employment relationship as stipulated by the act which regulates employment relationships, and the collective agreement in the field of trade in Slovenia, primarily by the provisions referring to the organisation of working hours, breaks, rests and bonuses arising from working hours which are less favourable for employees.
Dealers may not determine the opening hours of stores on Sundays and other work-free days defined by law.
Exceptions are stores with sales area of up to 200 square meters at service stations, border crossings, ports for public transport, airports, railway and bus stations and hospitals.
Exceptions also include stores with a sales area of up to 200 square meters, if work on Sundays and other work-free days defined by law in their stores is performed exclusively by a person who as a sole proprietor is a commercial activity operator or by his or her procurator or a legal representative or procurator of a legal person involved in the commercial activity.
Work on Sundays and statutory work-free days together with a sole proprietor, a sole proprietor or his or her procurator or legal representative or the procurator of a legal entity involved in a commercial activity, can also be performed by a person who may perform temporary or occasional student work in accordance with the law governing employment and unemployment insurance, and by a person who may perform temporary or occasional work in accordance with the law governing the labour market.
Evidence
A schedule of working hours of the outlet must be published in a visible position near the entrance to the outlet.
Legal basis
Administrator of Legislation
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The scales used for measuring in the following fields:
- protection of human and animal health,
- environmental protection and general technical safety,
- goods and services traffic,
- procedures before administrative and judicial authorities
must fulfil metrology requirements confirmed with the first and regular certification during the whole period of application.
The first certification of the metering device is the examination of the new metering device and confirmation of its conformity with the approved type and/or prescribed metrology requirements for the respective type of metering device. The first certification is provided by the producer of the metering device or his authorised representative.
Regular certification of the metering device must be provided by its owner.
The extraordinary certification is mandatory for metering devices which were excluded from application due to re-modelling, fault or other technical deficiencies. The compliance of metering devices with the metrology requirements is determined by applying the extraordinary certification. The extraordinary certification is provided by the holder of the metering device.
Regular and extraordinary certifications are conducted by the Metrology Institute or the appointed legal entity or sole trader.
Evidence
Certification designation on the metering device.
Legal basis
Administrator of Legislation
Competent Authority
Metrology Institute of the Republic of Slovenia
Tkalska ulica 15
3000 Celje -
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
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Detergents are products that have a cleaning function and are intended for cleaning textiles or hard surfaces. They can be in any physical form (liquid, powder, paste, pieces ...) and can be intended for both domestic and industrial use. The term "detergent" also includes auxiliary cleaning and washing agents, e.g., products intended for pre-washing, bleaching and rinsing laundry, fabric softeners, etc.
The trade of detergents in the Republic of Slovenia (and the EU) is regulated by the European Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents. This Regulation is directly applicable, and for its implementation, the Government of the Republic of Slovenia issued the Decree on the Implementation of the Regulation (EC) of the European Parliament and the Council on Detergents (Official Gazette of the Republic of Slovenia, No. 66/2005).
Restrictions on surfactants
Detergents may only contain surfactants that meet the prescribed biodegradability conditions. The criterion for biodegradability is at least 60% mineralization (final aerobic microbiological degradation of surfactants into carbon dioxide, water and mineral salts) within 28 days. For detergents intended exclusively for use in industrial plants and establishments (Article 4 (2)), the primary biodegradability criterion may be used instead of the definitive one. This means the microbiological degradation of surfactant molecules and the consequent loss of surfactant properties must be at least 80%. In this case, the manufacturer/importer must apply for specific authorization for the use of such surfactant.
The methods for determining the ultimate biodegradability are set out in Annexes II and III.
Phosphorus limitation in detergents
Household laundry detergents may contain a maximum of 0.5 g of total phosphorus per washing cycle, and household dishwashing detergents may contain 0.3 g of total phosphorus per dose.
Informing users
The packaging of detergents intended for general use must indicate all the ingredients (or groups of ingredients) listed in Annex II which the product contains in concentrations above 0,2% and their concentration ranges. Textile washing detergents intended for general use must bear, in addition to the above information, the dosage instructions on the packaging, which are described in more detail in Annex III. Allergenic fragrances listed in List III of Directive 76/768 EC on cosmetic products must always appear on the packaging with the names of the Cosmetics Directive when their concentration in the product exceeds 0.01%. The ingredient and dosing requirements do not apply to detergents intended for industrial use if equivalent information is available in a different way (technical specifications, safety data sheets (). The inscription on the label must be visible and legible, and for detergents on the market in Slovenia, in the Slovenian language. Nor does the regulation require the indication of the date of manufacture or the expiry date of the detergents. However, if this information is provided on the packaging, it must be legible and understandable to the consumer.
Manufacturers and importers of detergents must publish a list of all ingredients, which may be without information on the concentrations of individual ingredients, CAS numbers, and the detailed composition of fragrances (with the exception of allergenic fragrances) and dyes, on a website that is regularly updated. The address of this website must be stated on the packaging.
Manufacturers and importers of detergents must also draw up a detailed list of ingredients, listing all the ingredients, regardless of their concentration, and their concentration ranges. This list is not of a public nature; manufacturers and importers must provide it for the needs of treatment in case of health complications to medical staff at their request.
In the production and trade of detergents, in addition to the above-mentioned and described regulation, it is also necessary to comply with all requirements and conditions that apply to the production and trade of hazardous chemicals.
Further explanations and answers to some specific questions and practical examples of the implementation of the Detergents Regulation can be found in the Frequently Asked Questions document.
Legal basis
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Hazardous chemicals are chemicals that have at least one of the hazardous properties in accordance with EU Regulation 1272/2008.
In the case of exports of hazardous chemicals to non-EU countries, they must be classified and labelled in accordance with EU Regulation 1272/2008 (unless the recipient country requires labelling in accordance with its legislation). The export of a chemical is accompanied by a safety data sheet in a language that the recipient of the chemical understands (if possible, this should be the national language of the recipient country).
Exporters of chemicals that are banned or severely restricted in the EU according to regulation 649/2012; (http:/echa.europa.eu/information-on-chemicals/pic/chemicals) must:
- for chemicals listed in Annex I, carry out a notification procedure via the e-PIC database at least 35 days before the first export to each third country. A simplified (and accelerated) notification process is possible for the export of small quantities of chemicals (up to 10 kg) for research and development purposes.
- Exports of chemicals listed in Annex V are prohibited, except for the export of small quantities of chemicals (up to 10 kg) for research and development purposes.