Prohibitions, permissions, restrictions, and other requirements

• Certain substances, particularly those that are carcinogenic, sensitizing, allergenic, or pose reproductive hazards, require a permit for handling.
• For more detailed information about chemical substances that necessitate a permit or notification, refer to the Swedish Work Environment Authority's guidelines on permits for chemical products. Additionally, the Swedish Work Environment Authority's regulation "Risks in the working environment" 2023:10 chapter 8.      
  • Permits for Group A Substances: Typically, Group A substances, mainly carcinogenic, are prohibited from being handled. However, permits may be granted for specific purposes such as research on a carcinogenic substance or development of measurement methods. This also applies to chemical products that contain such a substance as a contaminant at a concentration of 0.1 weight percent or more.
  • Permits for Group B Substances: Substances in Group B, which include carcinogens, sensitizers, allergens, and reproductive hazards, may only be handled after obtaining a permit from the Swedish Work Environment Authority. This rule also applies to products containing a Group B substance in a concentration of 1 weight percent or more.
• The responsibility for applying for a permit and registering the application falls on the unit/department intending to use the substance.
• Be aware that the permit process can take several months, and permits are typically valid for a limited period, usually between 1 to 3 years.
• Important Note: A valid permit is required not only for the use but also for the purchase or storage of Group A or Group B substances. Failure to comply may result in a sanction fee of 400,000 SEK for Group A substances and 150,000 SEK for Group B substances.

Campus-wide permits for flammable goods are sought at Linköping University (LiU), and collectively at Region Östergötland for flammable goods. For more information on this topic, refer to the 'Fire Precautions' subject pages under the 'Management of Flammable Goods' heading.

• Explosive precursors are substances that can be used to create homemade explosives. To prevent terrorism, the EU has implemented specific regulations under the EU Regulation 2019/1148, marketing and use of explosives precursors, which governs the marketing and use of explosive precursors and controls the availability of products containing these substances.
• According to these rules, professional users, such as LiU, are allowed to use products containing explosive precursors. However, they must complete a goods declaration when ordering these substances and report significant thefts or losses of products containing explosive precursors. LiU falls under the category of a professional user and must comply with these legal requirements.
• Further information about explosive precursors and the relevant European and Swedish legislation can be found in Swedish on the MSB's pages about Flammable and Explosive substances. A guideline is available regarding EU Regulation 2019/1148 on the marketing and use of explosives precursors.
• Examples of explosive precursors include nitric acid, hydrogen peroxide, sulphuric acid, acetone, and ammonium nitrate. For a comprehensive list, refer to Annex I and II in EU Regulation 2019/1148.

Purchasing certain explosive precursors

When purchasing certain explosive precursors, a special goods declaration (customer assurance) is required. More details can be found in the Management of chemicals section, Purchase, manufacture and End-User Declaration (EUD).

Report requirements in case of theft or disappearances

Those handling explosive precursors regulated by EU Regulation 2019/1148 must report significant thefts or losses of these substances to the police withing 24 hours of discovery. Reports should primarily be sent to prekursor@polisen.se, or by calling the police at 114 14. In addition, any incident related to LiU's operations should be reported to LiU's Environmental and Safety Unit via email at sakerhet@liu.se. Each case of disappearance or theft should be evaluated individually to determine if it is significant.

The reporting requirement applies to:

• Hydrogen peroxide (CAS 7722-84-1)
• Sodium perchlorate (CAS 7601-89-0)
• Sodium nitrate (CAS 7631-99-4)
• Nitromethane (CAS 75-52-5)
• Sulphuric acid (CAS 7664-93-9)
• Calcium nitrate (CAS 10124-37-5)
• Nitric acid (CAS 7697-37-2)
• Ammonium nitrate (CAS 6484-52-2)
• Calcium ammonium nitrate (CAS 15245-12-2)
• Potassium chlorate (CAS 3811-04-9)
• Acetone (CAS 67-64-1)
• Magnesium nitrate hexahydrate (CAS 13446-18-9)
• Sodium chlorate (CAS 7775-09-9)
• Hexamine (CAS 100-97-0)
• Aluminium, powders (CAS 7429-90-5)
• Potassium perchlorate (CAS 7778-74-7)
• Potassium nitrate (CAS 7757-79-1)
• Magnesium, powders (CAS 7439-95-4

Products that contain at least five ingredients, with each explosive precursor constituting less than 1% by weight, are exempt from the rules concerning reporting requirements.

Certain chemical substances are deemed particularly hazardous by the European Chemicals Agency (ECHA) and are listed in Annex XIV ("the Authorization List") of REACH, which is updated periodically. To use these chemical substances, authorization from ECHA is necessary. During the authorization process, safer alternatives must be explored, and hazardous substances should be replaced if viable alternatives are available, both economically and technically.

ECHA also compiles a Candidate List of particularly hazardous substances, known as "substances of very high concern" (SVHC). These substances are potential candidates for inclusion in Annex XIV, the Authorization List in REACH, and may require authorization for use.

Complementary Swedish legislation applies to the prohibition on the use of chlorinated solvents (e.g. methylene chloride), see förordning (1998:944) om förbud i vissa fall i samband hantering, införsel och utförsel av kemiska produkter (only available in Swedish).

For more information, visit the Swedish Chemicals Agency's pages on REACH and chlorinated solvents.

Exemptions from requirement for authorization

A general exemption from the authorization requirement exists for the use of these substances in scientific research and development, as per Article 56.3 of the REACH Regulation 1907/2006. This exemption means that scientific research and development activities do not need to apply for authorization. It applies to:

• Scientific experiments, analyses, or chemical research conducted under controlled conditions. This includes experimental research or analytical activities at the laboratory scale, such as synthesis, testing of chemical applications, release tests, etc., and the use of substances in monitoring and routine quality control or in vitro diagnostics at the laboratory scale, provided there are procedures in place to minimize risk of exposure to humans or the environment, and for waste management.
• Work conducted within research projects, such as doctoral training, thesis work, or similar activities.
• The total amount of a substance used must not exceed one ton per year per legal entity (e.g., within LiU as an organization).

NOTE: This exemption does not extend to undergraduate education.

If the exemption is also applicable to product- and process-oriented research and development, this will be specified in Annex XIV, along with the maximum amount for which the exemption applies. Otherwise, the authorization requirement remains in force.

Similarly, despite the general prohibition, methylene chloride may be used in research and developement, see the provision from the Swedish Chemicals Agency, KIFS 2017:7 om kemiska produkter och biotekniska organismer (only available in Swedish). The exemption from the prohibition on using methylene chloride at LiU applies to research and development but not to undergraduate education.

Purchasing chemical products prohibited under REACH

When purchasing chemical products that are prohibited under REACH, the buyer often needs to certify their exemption eligibility through an end-user declaration (EUD).

Chemical products forbidden in education

The general exemption allowing the use of certain chemical products in scientific research and development, which would otherwise require authorization, does not extend to educational settings. This means that chemical products listed in Annex XIV (Annex 14, "the Authorization List") of the REACH Regulation are prohibited from use in undergraduate education or equivalent settings. However, this exemption is applicable to research projects, including activities like doctoral training, thesis work, or similar.

This document summarises the legislation pertaining to Narcotics, Narcotic Precursors, Hazardous Substances, and so-called Substances Under Investigation (In Swedish).

Narcotics and medicines classified as narcotics

According to the Narcotic Drugs Control Act (1992:860), Section 7, narcotics may be held without a permit by the head of a scientific institution that is owned or supported by the state. Further details are available on the Swedish Medical Products Agency’s website.

Substances classified as narcotics are itemised in the Medical Products Agency's regulation concerning schedules of narcotic drugs (LVFS 2011:10). This regulation is updated regularly to include new substances. Amendments and so-called consolidated regulations, which compile changes, can be accessed via the Swedish Medical Products Agency’s website under the section for laws and regulations, organised by subject.

Requirements for handling narcotics and narcotic-classified drugs

• Access Control: Access to narcotics should be restricted to a limited number of authorized individuals. It is required to maintain a record within the operation documenting who is permitted to handle narcotics, as stipulated by LVFS 2011:9 §26. The specific narcotic substances being handled must be listed, and this record should be updated immediately upon any change. All documentation must be retained for five years.
• Record-Keeping: A meticulous narcotics log must be kept to ensure the traceability of all narcotics and narcotic-classified drugs, detailing quantities that are purchased, imported, exported, utilized, or discarded. This log must be continuously updated and available for review by the Swedish Medical Products Agency upon request. Additionally, an annual summary of narcotics records must be compiled. All records should be preserved for five years.
• Inventory Checks: An annual inventory of narcotics and narcotic-classified drugs is mandatory, with the actual quantity on hand being reconciled against the recorded stock balance. Discrepancies must be investigated and documented, and unexplained variances must be reported to the head of the department or equivalent. In cases where theft or loss is suspected, the security manager must also be notified.
• Annual Reporting: The requirement for the head of a scientific institution to submit annual reports to the Medical Products Agency on narcotics possession has been abolished, although this update may not be reflected on the Agency's website.
• Other Requirements: There may be additional reporting requirements for permissions related to the import or export of narcotics.
• Secure Storage: Narcotics must be stored securely to ensure that only authorized personnel can access them. This typically involves locking them in a dedicated cabinet or another secure location.

Narcotic precursors

Supply Control: A key strategy to prevent the manufacture of illegal narcotics is to limit access to essential precursor chemicals. This effort involves collaboration between industry associations and various authorities, including the Swedish Medical Products Agency, the National Operative Department of the Police, and the Customs Service.

Substances requiring a permit

Category 1, for example

• Ephedrine
• Ergometrine
• Ergotamine
• Chloroephedrine
• Chloropseudoephedrine
• Lysergic acid
• 1-Phenyl-2-propanone
• Pseudoephedrine
• Norpseudoephedrine
• N-Acetylanthranilic acid
• 3,4-Methylenedioxyphenylpropan-2-one
• Isosafrole
• Piperonal
• Safrole
• Alpha-phenylacetoacetonitrile

Acetic anhydride and red phosphorus - possession registration may be required

Registration is required for the possession of more than 100 litres of acetic anhydride (within the entire LiU, not per individual operation) or 0.5 kg of red phosphorus over a 12-month period. If you plan to use large quantities of acetic anhydride, please contact LiU's coordinator for chemical management.

Substances That Do Not Require Registration or Permit for Possession Only

For categories 2B and 3, the following substances do not require registration for possession only:

• Anthranilic acid
• Phenylacetic acid
• Piperidine
• Potassium permanganate
• Acetone
• Ethyl ether
• Methyl ethyl ketone
• Toluene
• Sulfuric acid
• Hydrochloric acid

For the most current information on substances classified as drug precursors, please visit the Swedish Medical Products Agency's website on drug precursors.

Health-hazardous goods

Health-hazardous goods are substances that, by virtue of their intrinsic properties, pose a risk to human life or health. These substances are used, or presumed to be used, with the intention of inducing intoxication or other effects. To regulate their availability, authorization from the Public Health Agency of Sweden (Folkhälsomyndigheten, FHM) is mandatory prior to using a substance classified as a health-hazardous good. Information on health-hazardous goods and the authorization application process is available on the Public Health Agency's website.

Which substances are classified as health-hazardous goods?

The most recent list of substances identified as health-hazardous goods can be found in the annex to Regulation (1999:58) on the prohibition of certain health-hazardous goods. To access the most current version, visit the Swedish Parliament's website. The updated annex is always positioned at the end of the web document, so it is advisable to scroll from the bottom up for ease of access.

Application for authorization

The application covers one calendar year (January to December). The Public Health Agency requires the following information:

1. A detailed application form indicating the specific health-hazardous goods in question, the quantities to be handled, their intended use, etc., available through the Public Health Agency's website.
2. As the application is made on behalf of LiU (using the organization number), it must be verified by someone authorized to represent LiU's operations. The Public Health Agency will require a signature from a designated signatory or a power of attorney for the applicant.

Regarding power of attorney ("fullmakt")

• A power of attorney is advantageous as it can be used for multiple applications, thus avoiding the need for a fresh signature from a signatory each year. Signatories at LiU are determined by a specific decision by the vice-chancellor (Rektor) which is updated annually and documented in LiUdok. often by the headline "generell rätt att teckna universitetets firma".
• LiU has developed a power of attorney template for use with the Public Health Agency-applications, valid for up to five years. If needed beyond this period, a new power of attorney must be issued.
• Ensure that the department head is informed when such an application is being made, by including them in the mailing list.
• Utilize LiU’s template for power of attorney, available in Swedish
• The completed power of attorney should be submitted to the Public Health Agency as instructed by them.
• All related documents should be officially recorded at the relevant department within LiU.

Regarding certificate of authority

• LiU has also created a template to certify an applicant's authority, valid for up to one year. If necessary, a new certificate should be issued subsequently.
• The certificate should be signed by the department head, who is responsible for verifying that the applicant's role and duties at LiU require the use of specific health-hazardous goods and that they are competent to handle them in compliance with the law.
• The department head must always sign the certificate, even if another manager can attest to the applicant's suitability.
• Inform the department head about the application by including them in the mailing list.
• The completed Certificate of Authority should be submitted to the Public Health Agency as instructed by them.
• All related documents should be officially recorded at the relevant department within LiU.

Materials derived from animals, known as animal by-products, are defined as "materials from the animal kingdom that are not intended for human consumption and have not yet been transformed into manufactured products." Examples of animal by-products include carcasses of dead animals and by-products from slaughtered animals, such as blood not designated for human consumption that is utilized in research. Other items classified as animal by-products are wool, feathers, eggs, embryos, sperm, cell lines, and serum of animal origin, as well as proteins and antibodies.

For further information on animal by-products, please refer to the Swedish Board of Agriculture's website section on products from animals.

To use animal by-products in research, authorization from the Swedish Board of Agriculture is mandatory. Linköping University (LiU) has obtained a collective authorization for such use. However, prior to commencing any new activities involving ABP, it is essential to consult with LiU's laboratory safety coordinator. This step ensures that the new activities fall within the scope of the existing authorization held by LiU.

Additionally, specific regulations govern the disposal of ABP waste. For detailed guidelines, refer to the topic pages for Waste under 'Laboratory Waste LiU', specifically the section 'Biological waste - tissue from animals (ABP) and plants'.

In research, obtaining export licenses is crucial for strategically sensitive products, including dual-use items. The issue of export control can become relevant in various scenarios within LiU's operations involving foreign contacts. This includes research projects with international partners, participation of LiU employees in global conferences, or other events where representatives from different countries are present. For more information, visit the section on export control and strategically sensitive products on LiU's intranet.

Research activities often necessitate a range of additional permissions. These may include ethical approval for studies, authorization for clinical drug trials, or access to biobank samples. Detailed information about these requirements and the process to obtain necessary permissions can be found on the page about research ethics and other permissions on LiU's intranet.

Mercury, mercury compounds and preparations are banned from use in Sweden.

The use of mercury, mercury compounds, and mercury-containing preparations is banned in Sweden. The Swedish Chemicals Agency has provided specific time-limited exceptions where no viable alternatives exist, detailed in Annex 3 of KIFS 2017:7. This means that mercury may continue to be used in certain applications (e.g., analytical chemicals) until the dates specified below:

Analytical chemicals	Exemption up until
Mercury compounds for the analysis of mercury and the development of such analytical methods	Indefinitely
Mercury compounds for analysis according to international standard methods in the pharmaceutical field	31 December 2025
Mercury compounds for COD analysisand in ampoules for COD analysis	31 December 2025
Mercury compounds for analysis, research and development in medical diagnostics	31 December 2025

Those utilizing mercury under the exemptions listed in Annex 3 are no longer required to document specific details such as the date of use, number of units, quantity, and area of use.

While the Swedish Chemicals Agency may grant exemptions beyond those in Annex 3, it is generally restrictive in doing so and will only consider strong reasons for an exemption. Further information about mercury can be found on the Swedish Chemicals Agency's website regarding mercury.

Additional details are provided in chapter 7 on mercury and mercury-containing goods in KIFS 2017:7, as well as in Regulation (1998:944) concerning prohibitions related to the handling, import, and export of chemical products.

Restrictions on use and purchase

Ozone-depleting substances (ODS) often contain chlorine (Cl) or bromine (Br). These substances are volatile and stable, allowing them to reach the stratosphere and impact the ozone layer. Common ODS include chlorofluorocarbons (CFCs) and hydrochlorofluorocarbons (HCFCs), previously used as propellants in aerosol cans and refrigerants. Carbon tetrachloride (tetrachloromethane) and 1,1,1-trichloroethane (methyl chloroform), used as solvents in laboratories, are other examples.

EU regulations (EC) No 1005/2009 on substances that deplete the ozone layer and (EC) No 291/2011 on essential uses of controlled substances other than chlorofluorocarbons for laboratory and analytical purposes outline the common rules for ODS in laboratory and analytical work.

A summary of critical uses ("essential use") that permit the use of various ODS is detailed in the MANUAL FOR LABORATORY USERS. This manual, along with information about licensing and reporting of ODS, is accessible via the EU Commission's page on the ozone layer. All other uses are prohibited.

Purchasing ozone-depleting substances (ODS)

Purchasing ODS requires a special ID number. For guidance, refer to the section on 'Chemical Management' regarding Purchase, manufacture and End-User Declaration (EUD).

Chemical substances/products may have assigned occupational exposure limit values which pertain to dust, smoke, mist, gas, and vapor. These limits are mandatory and must be adhered to in the workplace. The occupational exposure limit value for a substance represents the maximum acceptable concentration of that substance in the workplace. Certain chemical substances can be absorbed by the body through both the lungs and the skin, especially those that are in liquid or gaseous form. Substances that are readily absorbed through the skin are indicated with an 'H' in the limit value list.

The Swedish Work Environment Authority's regulation on occupational exposure limit values Hygieniska gränsvärden (AFS 2018:1) provides an alphabetical list of substances with established limit values. Detailed information for individual substances is also available in the chemical management system KLARA (see the section on Chemical handling system). Additional information on air pollutants and their limit values can be found in Swedish on the Swedish Work Environment Authority's website dedicated to air pollutants and limit values.

Briefly on different limit values

Long Term Exposure Limit values: (in Swedish, NGV=Nivågränsvärde)

Sometimes referred to as time-weighted average (TWA) limit values. A reference period is often the standard reference when discussing occupational exposure limit values and is applicable to eight-hour work shifts. Sampling typically spans an entire workday, which usually means eight hours, including active work periods but excluding rest breaks.

STEL (Short-Term Exposure Limit values): (in Swedish, KGV=Korttidsvärden)

Measured over a brief period. STEL refers to hygienic limit values for exposures occurring over a short duration, typically 15 minutes, although the exact reference time can vary depending on the substance. STEL can be classified as either binding or indicative; a binding STEL must not be exceeded under any circumstances.