Declaration and Labelling of Microbiological Products

The purpose of these regulations is to prevent the microorganisms in microbiological products from damaging human health or having detrimental environmental effects in the form of disturbance of ecosystems, pollution, waste, etc.

Laid down by the Ministry of the Environment 22 January 1998 pursuant to section 4, first paragraph, litra a, of Act No. 79 of 11 June 1976 relating to the control of products and consumer services (the Product Control Act), cf Royal Decree No. 730 of 7 September 1990. Cf. enclosure II chap. XIX (Directive 83/189/EEC with later modifications in the EEA agreement. Last amendment 24 May 2005.

 

§ 1 Purpose

The purpose of these regulations is to prevent the microorganisms in microbiological products from damaging human health or having detrimental environmental effects in the form of disturbance of ecosystems, pollution, waste, etc.

§ 2 Scope

These regulations apply to the declaration and labelling of microbiological products that are imported to, manufactured in or placed on the market in Norway.

The regulations apply to microbiological products for applications that may involve their release to the outdoor environment, for example because

a)       the product is intended to be used and left out-of-doors,

b)       the product is intended to be used and left indoors in such a way that the microorganisms are nevertheless released to the outdoor environment, for example through drains, open doors or windows, ventilation systems, etc.

The regulations do not apply to microbiological products that are regulated by or pursuant to other Acts which safeguard the same purpose as the duty to declare (cf section 4, cf section 1), including:

–         Act No. 3 of 19 May 1933 relating to the control of food products

–         Act No. 9 of 5 April 1963 relating to pesticides, etc

–         Act No. 1 of 14 March 1964 relating to measures to combat plant diseases and plant pests

–         Act No. 83 of 4 December 1970 relating to trade in fertilizers and soil improvers, etc.

–         Act No. 18 of 23 March 1973 relating to the inspection of feedingstuffs

–         Act No. 132 of 4 December 1992 relating to medicinal products

–         Act No. 38 of 2 April 1993 relating to the production and use of genetically modified organisms.

In cases of doubt, the Norwegian Directorate for Nature Management or the authority designated by the Norwegian Ministry of the Environment will determine whether or not the product comes within the scope of the regulations.

§ 3 Definitions

In these regulations, the following terms mean:

Microorganism: any microbiological entity that is able to reproduce or transfer genetic material, including viruses, bacteria, single-celled plants and animals and microscopic yeasts and moulds.

Microbiological product: any raw material, adjuvant, intermediate product or finished product of any kind which consists of or contains microorganisms for specific applications, including sanitary cleaning, deodorization, cleansing drains, grease control and cleaning up oil spills and contaminated sites.

§ 4 Duty to declare products

Any person that manufactures or imports microbiological products or places them on the market in Norway has a duty to declare any information necessary for an assessment of the risk the product poses of damage to human health or detrimental environmental effects, including a description of the product and its composition, area of application and mode of use, cf. the appendix concerning information to be declared pursuant to these regulations.

Declaration of a microbiological product must be effected at the latest when manufacture or sales start or when the product is placed on the market in Norway. The declaration shall be sent to the Product Register.

The person responsible for the declaration shall send a new declaration if the quantity, application or composition of the product is altered appreciably in relation to the specification in the initial declaration, or if other alterations take place which may be of importance in assessing the effects of the product on human health or the environment.

The person responsible for the declaration shall notify the Product Register if the product is given a new name or if the labelling on the product is altered.

The Product Register may require that all the information required pursuant to the first paragraph is updated.

§ 5 Duty to label products

Any person that manufactures or imports microbiological products or places them on the market in Norway has a duty to ensure that the packaging of the product is labelled in Norwegian with the following:

  1. The name, full address and telephone number of a Norwegian manufacturer, importer or distributor in the EEA area.
  2. The designation or trade name of the product.
  3. The area of application of the product.
  4. Recommended precautions in connection with use (respiratory equipment, personal protective equipment, hygienic measures, recommended method of destruction, etc).

§ 6 Exemptions

The Norwegian Directorate for Nature Management or the authority designated by the Norwegian Ministry of the Environment may by individual decision or regulations make exemptions from the provisions of these regulations.

§ 7 Compliance

The Norwegian Directorate for Nature Management or the authority designated by the Norwegian Ministry of the Environment will be responsible for ensuring the implementation of these regulations.  

§ 8 Penal measures

Any person who contravenes these regulations is liable to a penalty pursuant to section 12 of the Act relating to the Control of Products and Consumer Services (the Product Control Act) unless the offence is subject to a more severe penalty.

§ 9 Coercive fine

In order to ensure compliance with the provisions of these regulations or decisions made pursuant thereto, the Norwegian Directorate for Nature Management or the authority designated by the Norwegian Ministry of the Environment may decide that a coercive fine shall be imposed, cf section 13 of the Product Control Act.

§ 10 Appeal

Individual decisions made pursuant to these regulations may, in accordance with the Public Administration Act of 10 February 1967, be appealed to the Ministry of the Environment.

§ 11 Entry into force and transitional arrangements

These regulations enter into force 1 February 1998.

Any person that on the date of entry into force of these regulations has placed on the Norwegian market microbiological products as defined in section 2 of these regulations shall within 1 year after the regulations have come into force declare and label such products pursuant to sections 4 and 5.

 

Comments on the regulations

Re section 2 Scope

Examples of products to which these regulations apply are microbiological products for sanitary cleaning, deodorization, cleansing drains, grease control, mineral leaching, cleaning up oil spills and other pollution, and the manufacture of artificial snow.

Examples of products which are intended to be used and left indoors, but which may nevertheless be released to the outdoor environment, are sanitary fluids and products for sanitary cleaning, deodorization, cleansing drains, etc.

The duty to declare products applies to naturally-occurring microorganisms and/or microorganisms that have been modified in ways that do not come within the scope of the definitions in section 4, litra c) and/or d) of the Gene Technology Act. Types of modification that are not considered to be genetic modification pursuant to the Gene Technology Act are:

–        mutations induced by means of mutagenic chemicals or radiation,

–        conjugation, transduction and transformation or other natural processes, provided that they do not involve the use of recombinant DNA molecules or genetically modified organisms,

–        the use of selective culturing techniques.

The regulations do not apply to diagnostic kits, biological test kits, etc, provided that the microorganisms in the product are destroyed in their entirety in a safe manner after use.

These regulations do not apply to products intended for applications in agriculture (e.g. feed additives, deodorizing agents for manure and preservatives for silage), in the food-processing industry (e.g. dairy products and brewing) and in the pharmaceuticals industry and in hospitals (e.g. for laboratory use).

Re section 3 Definitions

A microbiological product may consist of a specific microorganism, a mixture of several specific microorganisms or a consortium. The product may also contain other substances, such as surfactants, deodorizing agents, enzymes, mineral nutrients, salts or other chemicals.

Re section 4 Concerning the duty to declare products and section 5 Concerning the duty to label products

Any person that manufactures and/or imports microbiological products or places them on the market in Norway has certain liabilities pursuant to the regulations. The regulations also apply to direct import for own use. Any person that re-packages a microbiological product and gives it a new name is to be considered liable pursuant to these regulations. Any person that re-packages a product without giving it a new name has, as the following stage in the chain of distribution, a liability pursuant to section 5 of the regulations.

As regards imported products, the authorities responsible for control and inspection will normally require that the first person that places the microbiological product on the Norwegian market shall comply with the requirements of the regulations.

The following stage in the chain of distribution shall ensure that the microbiological products are labelled and declared pursuant to the regulations at all times.

Although the responsibility for compliance with the provisions of the regulations lies with the person that places the microbiological product on the market, the tasks of labelling and declaration may be delegated to others (e.g. an agent or a contract manufacturer (physical manufacturer). However, the authorities responsible for control and inspection will deal with the person liable pursuant to the regulations. A private law contract as to who is to be responsible for declaring a product is not of decisive importance for the authorities responsible for control and inspection in determining who is considered to be liable.

Re section 4 Concerning the duty to declare products

The information to be declared pursuant to these regulations is specified on a form prescribed by the Norwegian Pollution Control Authority. The information considered necessary at present is indicated in an appendix to the regulations. Separate guidelines explaining the documentation required to give satisfactory answers to the various questions may be obtained from the Norwegian Pollution Control Authority.

The declaration shall be sent to:

The Product Register
Norwegian Environment Agency
PO Box 6257 Etterstad
NO-0603 Oslo, Norway

 Or by E-mail to:

produktregisteret@miljodir.no

 It is not recommended to send business confidential information by E-mail

Any person that manufactures and/or imports any type of product has a duty to possess or obtain such knowledge as is necessary to assess whether the product may cause damage to human health or environmental disturbance, cf section 3 of the Product Control Act. A person that only places a product on the market does not have the same duty to possess or obtain knowledge, but does have a duty to exercise due care and implement reasonable measures to prevent damage to human health or environmental disturbance. In many cases, the duty to exercise due care will involve a duty to have some knowledge of the products being dealt with.

Some knowledge of microbiology/microbial ecology/toxicology is necessary to fill out the declaration form for microbiological products satisfactorily and to assess any risk of damage to health or detrimental environmental effects caused by the product. If the person responsible for declaring the product does not possess sufficient expertise, it will be necessary to consult experts to ensure compliance with the provisions of the regulations.

When a microbiological product has been declared, this means that it has been entered in the Product Register, but not that it has been approved by the pollution control authorities. Thus, declaration imposes no restriction on duties pursuant to the Product Control Act, nor does it preclude the recall or prohibition of a product or its regulation in other ways pursuant to the Product Control Act.

Nor do these regulations restrict the duty to classify, label, package and declare chemicals pursuant to the Regulations relating to the classification, labelling, etc of dangerous chemicals. Microbiological products which also contain substances or preparations to which the above-mentioned regulations apply shall also be labelled and declared pursuant to the provisions of the Regulations relating to the classification, labelling, etc of dangerous chemicals in addition to being declared and labelled as microbiological products.

Re section 5 Duty to label products

Re item 4 on recommended precautions: any person that manufactures a microbiological product and/or places it on the market shall evaluate whether specific precautionary measures should be recommended in connection with its use, cf Part 3 of the form in Appendix 1. The recommended measures shall be listed on the packaging for the product.

Re section 11 Entry into force and transitional provisions

These regulations enter into force 1 February 1998.

However, there are transitional arrangements for any person that manufactures microbiological products and/or places them on the market and that already has such products on the Norwegian market when the regulations enter into force. This is to give those who manufacture microbiological products and/or place them on the market a reasonable amount of time to obtain the information necessary to comply with the duty to declare products, and to ensure that products are labelled as prescribed by the regulations.

Declaration form

Regulation concerning the declaration and labelling of microbiological products.

Please consult the guidelines when answering these questions.

Part 1 General information

1

Norwegian manufacturer/importer (name and address, enterprise no., telephone and telefax no.

2

Manufacturer abroad (name, address and telephone no.).

3

Trade name of the product (in accordance with the name on the packaging)

4

Class/branch(es) of industry where the product is used

5

Product type

6

Quantity of product (weight/volume) manufactured/imported per year

7

Physical data

8

Technically qualified persons consulted

9

Date

Part 2 Compsition of the product

10

Specify which microorganisms are present in the product:

a)   Does the product contain several strains of microbes brought together deliberately? If so, give the designations of all those included in the product to strain level.

b)   Does the product contain an enriched, natural consortium only? If so, give the names of the dominant strains at least to generic level, the material from which the consortium is taken and the enrichment procedure and medium used. A natural microbial consortium means the microorganisms naturally present in a habitat.

11

Specify the concentration(s) of the microorganism(s) present in the product itself.

12

Specify the chemical substances present:

CAS no., chemical name, EC number, classification, content as percentage by weight.

Part 3 Information on any pathogenic properties of the microorganisms

13

Has it been reported that the microorganism(s) or other strains of the same species have caused disease/injury in humans, animals or plants (name of the disease, host organism, disease mechanism)?

14

Specify the tests that have been made to ensure that the product is not contaminated with unwanted microorganisms, particularly pathogenic microorganisms.

15

Specify recommended precautions to be taken in connection with use of the product (respiratory equipment, personal protective equipment, hygienic measures, etc)

Part 4 Information on inactivation of microorganisms

16

Does the product contain live microorganisms, including viable spores (bacteria and fungi) or cysts (protozoans)?

If the manufacturer or importer has substantiated that the answer to question 16  is no, the following questions need not be answered, with the exception of nos 25 - 28.

Part 5 Information on where and how the product is to be used

17

Where is the product intended to be used, and is this environment appreciably different from the environment from which the microorganisms have been isolated?

18

How are the microorganisms released to the environment?

19

With respect to the microorganisms, what are the typical concentrations, quantities (quantity per unit of volume, weight or area) and frequencies of application, and the total number of applications?

Part 6 Description of the microorganisms

20

Have the microorganisms been deliberately altered since their isolation, and if so how?

21

For products containing bacteria: what pattern of resistance do they show to antibiotics (including synthetic antibacterial agents)?

22

Do the microorganisms have special survival mechanisms, for example the formation of spores in bacteria?

Part 7 Ecological effects related to degradation processes

It is only necessary to answer questions 23 and 24 if the microbiological product is intended for use in the degradation of pollutants. All questions in Part 7 apply to the use of the microbiological product as a whole, i.e. including both the microorganisms and any additional substances.

23

Give a brief description of metabolic pathways for the degradation of the pollutants in question or, if appropriate, of similar compounds.

24

Does the degradation process involve the formation of stable intermediate products with different and/or environmentally more harmful properties than the original compounds (toxicity, biodegradability, bioaccumulation potential, solubility in water, carcinogenicity)? Specify the chemical identity of any environmentally harmful intermediate products.

25

Can the product have undesirable effects on important natural microbial processes in the environment, for example nitrogen/phosphorus cycles and carbon mineralization, or by altering pH or oxygen concentration?

Part 8 Other relevant information

26

Give any other information in the form of empirical or test data that is relevant to the hazard to health or the environment posed by use of the microbiological product, and to which the importer/manufacturer has or should have access.

Part 9 Overall assessment of risk to human health and the environment

27

Give an overall assessment of the risk to human health and the environment posed by use of the product.

 

28

Signature

 

Guidelines for completing the declaration required according to the regulations relating to the declaration and labelling of microbiological products for applications that may involve their release to the outdoor environment

Introduction

The Regulations relating to the declaration and labelling of microbiological products for applications that may involve their release to the outdoor environment require all those who manufacture or import microbiological products or place them on the market to provide the environmental authorities with certain information on their products. It is particularly important to obtain information on any risks to human health and the environment.

The main purpose of the declaration requirements is to ensure that those responsible for the manufacture and sales of microbiological products know more about the risks to human health and the environment associated with the use of such products. When a microbiological product has been declared, this means that it has been included in the Product Register, but not that it has been approved by the pollution control authorities. If assessment indicates that the use of a microbiological product will involve an unacceptably high risk to human health or the environment, the Product Control Act provides authority to stop sales and use of the product in Norway.

In these regulations, a microbiological product is defined as a product containing microorganisms and intended for non-contained applications. Non-contained means that the product is used directly in the outdoor environment or that it is used in such a way that the microorganisms are likely to be released to the outdoor environment. Examples of such uses are sanitary cleaning, cleansing drains and cleaning up oil spills or other types of pollution. The regulations do not apply to products containing microorganisms intended for use solely in laboratories or enclosed structures/reactors.

In this context, a microorganism is understood to mean any microbiological entity that is able to reproduce or transfer genetic material, including viruses, bacteria, single-celled plants and animals and microscopic yeasts and moulds. Most microbiological products in use today contain bacteria, while yeasts and moulds are used to a more limited extent. However, compound microbiological products may also contain other types of microorganisms. For example, products intended for cleansing drains may contain protozoans. As far as we know, no products currently on the market contain monocultures of viruses, microalgae or protozoans.

A microbiological product often contains not only microorganisms, but also one or more of the following components: nutrients, surfactants and enzymes. Such additives are regulated by separate acts and regulations, and for this purpose only information on their chemical names, CAS numbers, EC numbers, classification and quantity is required.

Part 1 General information Question

1. Norwegian manufacturer/importer/distributor in the EEA area

Give the name and telephone number of the Norwegian company responsible for declaration of the product, together with its enterprise number, and the telephone and telefax numbers of the section of the company responsible for declaration.

Question 2. Manufacturer outside the EEA area (name, address and telephone no.)

Give the name, address and telephone number of the manufacturer outside the EEA area so that supplementary information can readily be obtained if necessary, for instance in the event of acute injury to health or environmental damage.

Question 3. Trade name of the product

Give the trade name of the product in full, as it appears on the packaging. It is important to include both the name and any code used (letters and/or numbers).

Question 4.Class/branch(es) of industry where the product is used

Indicate briefly the class/branch(es) of industry where the product is used. A designation such as “refuse disposal and industrial cleaning”  or “offshore industry” is required.

Question 5. Product type

Give a brief description of the product type or types, using a designation such as “sanitary cleaning fluid”, “product for oil degradation”, etc.

Question 6. Quantity of product (weight/volume) manufactured/imported per year

Give the exact amounts of the product manufactured, cultured, processed, repackaged, renamed and imported in the previous year. If the product is new on the Norwegian market, give the figures for the current year.

In cases where it is necessary to give several figures, list the total quantities of the product actually manufactured, cultured, processed, repackaged, renamed and imported.

If the product is used on-site, give separate figures for the quantities used for further production (as raw material) and for consumption (end product) within the company.

Question 7. Physical data

Give information on the form and consistency of the product, e.g. solid, powder, paste, liquid, aerosol or other.

Question 8. Technically qualified persons consulted

List the name, position and scientific qualifications of the person(s) who have assessed  the product on behalf of the company responsible for the declaration.

Question 9. Date

Give the date on which the declaration form was filled out.

Part 2 Composition of the product

Purpose of Part 2: To identify all components of the product, both microorganisms and chemical components.

Question 10. Which microorganisms are present in the product? Identification to species or to subspecies and strain

Give the scientific name of the microorganism (genus, species, if appropriate subspecies and strain). The designation for a strain may be the reference number a microorganism is given when it is deposited in a recognized culture collection. An example of a designation identifying a bacterium is as follows: Pseudomonas aeruginosa  ATCC 10145T. The “T” indicates that the type strain for the species is ATCC (American Type Culture Collection) number 10145. If the microorganism in question has not previously been identified to strain, the local designation given to the strain by the laboratory involved may be used.

Test data must be submitted to show that the microorganism in question has species- and strain-specific traits. It must be possible for an independent third party to confirm that the product contains the microorganism specified by testing for the species- and strain-specific traits described in the documentation. For bacteria, Bergey´s Manual of Systematic Bacteriology is a useful aid to species- and in some cases strain-specific traits. There is no corresponding manual for fungi/moulds and yeasts, but several textbooks and reference books are available. We also recommend searching databases.

If the manufacturer has deposited the microorganism in a recognized culture collection, the registration form submitted for this purpose will generally be sufficient to substantiate the identity of the microorganism. In such cases, a copy of the registration form should be enclosed. Examples of recognized culture collections are the American Type Culture Collection (ATCC), Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSM) and the National Collection of Industrial and Marine Bacteria (NCIMB).

If the product contains an enriched, natural consortium only, it is not necessary to identify all the microorganisms it contains. Only the dominant strains need be identified. These must be identified at least to genus. In addition, the material from which the consortium is taken must be described (e.g. compost mixed with human or animal faeces), and the enrichment procedure and medium used must be specified. A natural microbial consortium means the microorganisms naturally present in a habitat.

Question 11. Specify the concentration(s) of the microorganism(s) present in the product itself.

If the product contains identified microorganisms, their concentrations (colony-forming units per gram or ml) must be given. If the product contains an enriched, natural consortium, individual concentrations (e.g. number of colony-forming units) of the dominant strains must be given, together with the total concentration of colony-forming units.

If the product contains inactivated microorganisms, the concentrations of these need not be given (see also question 18).

Since the concentration of microorganisms in the product may vary from one production batch to another, it is sufficient to give maximum and minimum values.

Question 12. Specify the chemical substances present: CAS no., chemical name, EC number, classification, content as percentage by weight.

The term chemicals means elements and their chemical compounds with other elements, either naturally occurring or manufactured industrially.

The CAS number is the identification number for a chemical given in the Chemical Abstracts Service Registry, where available.

A chemical has an EC number if it is in use on the European market. The EC number of a chemical is found in either EINECS or ELINCS.

For a substance listed in the Norwegian List of Substances, the name under which it is listed there shall be used. In other cases, the EINECS or ELINCS designation should be used where possible. Otherwise, internationally recognized chemical names should be used (e.g. ISO or IUPAC).

Classification: dangerous chemicals shall be classified on the basis of the information necessary to determine the health, fire, explosion and environmental hazards related to the substance or preparation. Chemicals shall be classified in accordance with the criteria laid down in the regulations relating to health, fire and explosion hazard labelling, the regulations concerning a list of substances and the regulations relating to environmental hazard labelling (all these are currently being revised and harmonized with EC legislation).

The quantities (concentrations) of chemicals shall be given as percentages by weight.

All components shall be listed.

Part 3 Information on any pathogenic properties of the microorganisms

Purpose of Part 3: to obtain information on any pathogenic properties of the microorganism(s)

Question 13. Has it been reported that the microorganism(s) or other strains of the same species have caused disease/injury in humans, animals or plants (name of the disease, host organism, disease mechanism)?

A list of naturally-occurring microorganisms that are human pathogens and lists of microorganisms that are animal or plant pathogens are enclosed with the guidelines. In these lists, human pathogens are placed in classes 2-4 depending on the risk of infection associated with them. Animal and plant pathogens are also divided into classes (2 and 3) according to their virulence in animals and plants.

The list of microorganisms that are pathogenic to humans is almost identical to the list drawn up as an annex to EC Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work. The same list will also be published as an appendix to regulations that are to be issued by the Ministry of Local Government and Labour on the classification of biological agents and containment levels. All the lists are also included as appendices to the regulations relating to contained use of genetically modified organisms laid down pursuant to the Gene Technology Act.

The enclosed lists should be used as a basis for an account of any pathogenic properties of the microorganisms in the product in question. Further information will be found in reference works such as Bergey´s Manual of Systematic Bacteriology. We also recommend searching databases such as Medline.

Microorganisms which are not on the lists cannot automatically be assumed to be non-pathogenic. The manufacturer must therefore also provide an assessment of microorganisms that are not on the lists. This must be properly substantiated.

In cases where the manufacturer or importer has carried out pathogenicity tests, a description of these and an account of the results is required.

Bacteria generally present a greater threat of infection to humans and animals than do fungi, whereas fungal diseases are commonest in plants. Protozoan infections are relatively uncommon in Norway. However, in other climate zones protozoans are known to cause a number of serious diseases in both humans and animals (e.g. sleeping sickness, malaria and dysentery). For products containing protozoans, state whether the protozoan in question belongs to a taxon which is frequently associated with disease. For example, all species in the subphylum Sporozoa are parasites.

If the microorganism or other strains of the same species have been reported to cause disease or injury in humans, animals or plants, the following information is required:

(1) Name of the disease: i.e. which disease/type of injury the microorganism causes.

(2) Host organism

(3) Disease mechanism: i.e. whether the microorganism causes disease by for example producing a toxin or inducing allergic reactions.

Microorganisms may cause disease or injury in a number of different ways. It is seldom the quantity of microorganisms in itself that causes symptoms. A very common disease mechanism associated with bacteria and fungi is the production of toxins.

However, the concentration and method of application are very important in determining whether or not the microorganism induces allergic reactions. The risk of  allergic reactions is higher if the product is used in powder form. Fungal spores are the microorganisms most often associated with allergic reactions.

(4) Risk classification: if the organism is included in the enclosed lists of human, plant and animal pathogens, specify the risk group in which it is classified.

If one or more of the microorganisms in the product may be associated with disease or injury, we require an assessment of whether the risk to human health and the environment during use of the product is unacceptably high.

Question 14. Specify the tests that have been made to ensure that the product is not contaminated with unwanted microorganisms, particularly pathogenic microorganisms.

The manufacturer shall describe the tests that have been made to ensure that the product is not contaminated with unwanted microorganisms, particularly pathogenic organisms. However, the product must also be tested to ensure that it only contains the microorganisms listed in the description. Since sterile techniques are not used during storage and handling of the product, it is not appropriate to require that the product is “pure”.

For products consisting solely of identified microorganisms, it will be sufficient to test for general contamination. This is done by culturing the product on a rich, non-selective substrate and at temperatures that are optimal for many pathogenic bacteria (30 - 37 oC). Blood agar is a suitable substrate for tests for pathogenic bacteria. It is the responsibility of the technical consultant to describe and give reasons for the culture method and result.

For products consisting of a natural, enriched consortium in which not all the microorganisms are identified to species level, more extensive testing for pathogenic microorganisms is required. For consortia based on enrichment of soil, compost, etc. or fresh water, tests for the following bacteria are required as a minimum (consortia based entirely on marine microorganisms are excepted):

(1)     Thermotolerant coliform bacteria: Consortia based on enrichment of microorganisms from soil, sediment, sand, compost, etc., or from fresh water, may contain bacteria of faecal origin. If thermotolerant coliforms (a group of intestinal bacteria) are shown to be present, this indicates that the product may also contain pathogenic microorganisms (bacteria, viruses and protozoans). Thermotolerant coliforms are good indicator organisms because they are normally found in large quantities in the intestines of both humans and other warm-blooded animals. The use of a standard test for thermotolerant coliforms is recommended (NS 4714.T1 (1991)). In addition, testing for faecal streptococci is recommended, using the test NS 4793 (1990). Faecal streptococci are particularly numerous in the intestines of warm-blooded animals. The concentrations of these indicator bacteria in the product should as a general rule not exceed the limits set for bathing water. The same limit applies both to thermotolerant coliforms and to faecal streptococci. Satisfactory bathing water shall contain below 100 cfu/100 ml water (i.e. fewer than 100 colony-forming units per 100 ml water). If the concentration of indicator bacteria exceeds the limit set for bathing water, documentation that the product does not contain pathogenic microorganisms is required.  A description of the tests to which the product has been subjected is also required.

(2)     Pseudomonas aeruginosa: The species P. aeruginosa occurs in soil and water and forms part of a number of microbiological products. It is capable of breaking down hydrocarbons. P. aeruginosa is also known to be an opportunistic human pathogen (causes infections of the urinary tract, ear and wounds). In addition, it often displays multiple antibiotic resistance, generally of a type that can be transferred to other bacteria (see question 21). The presence of P. aeruginosa is demonstrated by culturing on a blood agar substrate, and it can be recognized by the characteristic appearance and smell of its colonies. For products containing P. aeruginosa, the risk to human health and the environment must be assessed on a case-by-case basis, depending on where the product is to be used, the pathogenic history of the bacterial strain and its pattern of resistance to antibiotics. If the risk is considered to be too high, the product should not be released to the environment.

The above-mentioned tests are not required in the case of consortia based on enrichment of sea water, provided that enrichment takes place entirely under marine conditions (i.e. salinity corresponding to that of sea water). This is because intestinal microorganisms from humans and other warm-blooded animals normally die in sea water. In addition, there is little likelihood of finding P. aeruginosa in sea water. For consortia consisting entirely of marine microorganisms, the manufacturer shall describe the tests that have been made to show that the product does not contain unwanted microorganisms.

The technical consultant(s) shall evaluate whether tests for pathogenic bacteria should also include anaerobic pathogenic bacteria. Any tests used must be described. If it is decided that such tests may be omitted, the reasons for this must be given.

Question 15. Specify recommended precautions to be taken in connection with use of the product (respiratory equipment, personal protective equipment, hygienic measures, etc.)

Specify the precautions users should take when using the product, for example the use of masks, gloves, special clothing, hygienic measures, etc.

Part 4 Information on inactivation of microorganisms

Purpose of Part 4: to determine whether or not the product contains live microorganisms. Unless the presence of live microorganisms is important for the performance of the product, they should be inactivated.

Question 16. Does the product contain live microorganisms, including viable spores (bacteria and fungi) or cysts (protozoans)?

If the product does not contain live microorganisms, including viable spores or cysts, describe how the organisms have been killed. Specify the method of sterilization (heat, radiation, chemical), the dose, and the concentration of microorganisms treated. Information on how the product has been tested to ensure that it does not contain live microorganisms is also required. A suitable culture medium for the microorganisms in question shall be described so that an independent third party can confirm that the microorganisms are not viable. If the product contains organisms that form endospores, spores or cysts, describe procedures for activating the spores or cysts and for further culture. This makes it possible to test whether the spores or cysts have been killed.

Part 5 Information on where and how the product is to be used

Purpose of Part 5: to obtain information that gives an indication of the risk of unwanted establishment and dispersion of the microorganism in the environment in which the product is intended for use.

Question 17. Where is the product intended to be used, and is this environment appreciably different from the environment from which the microorganisms have been isolated?

Describe the outdoor environment to which the microorganisms are to be released: soil, water, sanitary facilities, waste treatment and disposal plants, etc. Information on the environment from which the microorganisms were isolated is also required. Specify the optimal growth temperature and suitable growth media for the microorganisms. If the environment in which the product is intended to be used is appreciably different from that from which the microorganisms were isolated, describe the most important differences. These may include differences in geographical location or in local conditions that affect temperature, salinity, pH, moisture, air supply, etc.

Question 18. How are the microorganisms released to the environment?

Describe the method(s) used to release the microorganisms to the environment. It is important to indicate whether they will be used in liquid or powder form and whether they are applied manually or for example by spraying from aircraft.

The method of application gives an indication of whether the microorganisms are dispersed in the environment in the form of aerosols or small particles, and of whether they will spread readily, for example via ground water. The method of application also influences the risk of allergic reactions to the product (see question 13).

Question 19. With respect to the microorganisms, what are the typical concentrations, quantities (quantity per unit of volume, weight or area) and frequencies of application, and the total number of applications?

Give information on the cell/spore concentration in the medium released to the environment. Specify typical quantities applied, as the amount of liquid or solid per unit volume, weight or area of the environment in which the product is used. This information gives an indication of the risk that the microorganisms will become permanently established in the environment.

Part 6 Description of the microorganisms

Purpose of Part 6: to obtain information on any traits of the microorganisms that have a strong bearing on the risk of injury to health or environmental damage.

Question 20. Have the microorganisms been deliberately altered since their isolation, and if so how?

In the same way as the effects of the deliberate release of genetically modified microorganisms are uncertain, there may be uncertainty as to the effects of releasing microorganisms that have been acted upon and altered using more traditional techniques.

Genetically modified microorganisms, i.e. microorganisms in which the genetic material has been altered by gene or cell technology, are regulated by the Act relating to the production and use of genetically modified organisms (the Gene Technology Act). The regulations relating to the declaration and labelling of microbiological products for applications that may involve their release to the outdoor environment do not apply to genetically modified microorganisms.

However, if the following methods are used to alter the genetic make-up of microorganisms, the organism is not considered to be genetically modified:

(1) Mutations induced by means of mutagenic chemicals or radiation.

Nevertheless, the Gene Technology Act applies to microorganisms altered by specific mutagenesis of DNA.

(2) Conjugation, transduction and transformation or other natural processes, provided that they do not involve the use of recombinant DNA molecules or genetically modified organisms.

(3) The use of selective culturing techniques.

It is possible to use natural recombination, mutagenic chemicals or radiation alone or in combination with selective culture techniques (selected substrate or other conditions under which the organisms are cultivated) to develop a microorganism with different traits from the original isolate (wild type).

State whether the organism has been modified by means of the types of techniques (including selective culture techniques) mentioned above, or whether the wild type has been retained. If the wild type has been deliberately acted upon and altered, both the method used and the alteration(s) shall be described.

Question 21. For products containing bacteria: what pattern of resistance do they show to antibiotics (including synthetic antibacterial agents)?

Various types of antibiotics (used here as a generic term for all types of antibacterial agents) are becoming gradually less effective as antibiotic resistance becomes more and more widespread. Resistance to antibiotics in bacteria may occur naturally or be acquired. In the case of naturally-occurring antibiotic resistance, the bacteria have species-specific traits which counteract the effects of the antibiotic in question. A typical example is resistance to penicillin in many Gram-negative bacteria, for example Escherichia coli. Antibiotic resistance is often transferable to other bacteria. Genes conferring transferable antibiotic resistance are generally located on plasmids (R plasmids). In addition, mobile genetic elements such as transposons and integrons contribute to the spread of resistance to antibiotics. A transposon is a short mobile DNA sequence which may carry one or more genes for resistance. An integron is a DNA sequence which makes it possible for several resistance genes from various sources to be linked together in the same DNA segment. It should be noted that antibiotic resistance can be transferred not only between closely-related strains of bacteria, but also between strains of different genera and families.

To determine whether or not the release of a bacterium to the environment should be permitted, it is important to evaluate: (1) its resistance to antibiotics of therapeutic relevance and (2) multiple antibiotic resistance. Documentation showing the pattern of resistance of the bacteria in the product shall therefore be submitted. Species-specific resistance or lack of resistance shall be documented using literature references. These may readily be obtained by searching databases. As regards acquired resistance, each bacterial strain must be tested. We recommend that bacteria should be tested using the PDM method marketed by AB Biodisk (Dalvegen 10, S-17136 Solna, Sweden).

In the PDM method, a single bacterial strain or a mixture of strains (consortia) is spread evenly on an agar plate and antibiotic tablets are placed on it immediately afterwards. If the bacterial strain is resistant to the antibiotic, it will grow even adjacent to the tablets. If the strain is susceptible to the antibiotic, there will be a zone with no bacterial growth around the tablets. Veterinary or medical tables based on inhibition zone limits are used to determine whether or not the bacterium is resistant.

The reason for recommending a test from a specific manufacturer is that AB Biodisk’s PDM system is very well documented. However, other similar internationally recognized systems for mapping bacterial patterns of resistance exist (e.g. Difco and Oxoid), and tests using these methods are also considered to provide satisfactory documentation.

On the basis of the antibiotics currently in use in human and veterinary medicine, we require testing using the following antibiotics:

Amoxicillin/Clavulanic acid, Ampicillin, Cephalothin, Chloramphenicol, Erythromycin, Fucidic acid, Lincomycin, Meticillin, Norfloxacin, Oxytetracycline, Penicillin, Trimethoprime/Sulfamethoxazole and Vancomycin.

In order to evaluate the health risk involved in releasing a bacterium to the environment, the extent and therapeutic relevance of resistance must be taken into consideration. It should be noted that acquired resistance is generally transferable.

Question 22. Do the microorganisms have special survival mechanisms, for example the formation of spores in bacteria?

Some microorganisms form survival and dispersal structures. These are called endospores in bacteria, spores in fungi and cysts in protozoans (though the term spores is often used for protozoans as well). Adverse environmental conditions often trigger the formation of spores and spore-like structures.

The formation of endospores in bacteria is a genus-specific characteristic. The best-known spore-forming genera are Bacillus and Clostridium, but Sporolactobacillus, Desulfotomaculum and Sporosarcina also form endospores. Most of the spore-forming genera are soil bacteria. Many of these species are pathogenic for humans or animals, for example Clostridium botulinum (botulism, a type of food poisoning with a high mortality rate), C. tetani (tetanus), Bacillus cereus (food poisoning), B. anthracis (anthrax in sheep and cattle, can also be transmitted to humans) and B. thuringiensis (insect pathogen).

Many protozoans, especially parasitic groups, form cysts, which are their dispersal structures and also responsible for the spread of disease.

For bacteria and protozoans, information on whether or not the organism can form spores/cysts is required. In fungi the formation of spores is so widespread that information is only required if the organism does not form spores.

Part 7 Ecological effects related to degradation processes

Purpose of Part 7: to obtain information on any environmental effects of the product, with special emphasis on the formation of harmful intermediate products during the degradation process.

It is only necessary to answer questions 23 and 24 if the microbiological product is intended for use in the degradation of pollutants. All questions in Part 7 apply to the use of the microbiological product as a whole, i.e. including both the microorganisms and any additional substances.

Question 23.  Give a brief description of metabolic pathways for the degradation of the pollutants in question or, if appropriate, of similar compounds.

It is assumed here that the product is designed to break down specific pollutants. Documentation of the metabolic pathway(s) for degradation of the pollutant(s) in question can normally be found in the literature.

A microbiological product may be designed to break down complex mixtures of pollutants such as crude oil. In such cases, it will be impossible to describe metabolic pathways for the degradation of all components. Instead, the components must be classified in generally recognized categories, and the degradation of a representative compound from each group must be described. For example, the components of crude oil are generally classified as n-alkanes, branched-chain alkanes, cyclic alkanes, aromatics, resins and asphaltenes.

If no description of the metabolic pathway for degradation of the pollutant in question is available, a probable metabolic pathway shall be documented using the degradation of a similar compound as a starting point.

The metabolic pathway for degradation of a compound is often determined under only one set of experimental conditions. These may be quite different from the environmental conditions in which the product is to be used. The documentation shall include an account of any such differences and an explanation of their possible consequences.

Question 24. Does the degradation process involve the formation of stable intermediate products with different and/or environmentally more harmful properties than the original compounds (toxicity, biodegradability, bioaccumulation potential, solubility in water, carcinogenicity)? Specify the chemical identity of any environmentally harmful intermediate products.

This question deals with any environmentally harmful effects of intermediate products. Such products must be so stable that they cause detectable damage before they are degraded further.

If a literature review does not provide adequate documentation, standard tests (e.g. the OECD/ISO tests described below) are recommended as a starting point for answering question 23. Even if such tests are carried out under conditions which may be significantly different from natural environmental conditions, they will give a good indication of whether harmful intermediate compounds are formed. Appropriate tests should be selected on the basis of whether the product is to be used in a fresh-water, marine or terrestrial (soil) environment.

Documentation may also be obtained using other standard tests than those specified below, or by means of simulated environmental studies. However, a satisfactory simulation study can constitute an entire research project in itself, and often requires extensive resources.

A relevant biodegradability test is recommended as the first step in investigating whether a degradation process involves the formation of environmentally harmful intermediate products. Such tests are designed to indicate whether or not stable intermediate products are formed during degradation and whether these are toxic. According to the OECD Guidelines for the Testing of Chemicals (1993), no further tests of the environmental effects of the degradation process are necessary if the results show that the pollutants are easily broken down (Ready Biodegradability Tests). However, if the degradation process appears to involve the formation of stable intermediate products, these should be identified before tests for toxicity, bioaccumulation potential, water solubility and carcinogenicity are carried out as described below.

Pollutants may be only sparingly soluble in water. However, with the exception of ISO test TC/147, SC5/WG4 N141-1990 (BODIS), standardized degradability tests are designed for water-soluble substances. If the pollutants in question are poorly soluble in water, an adapted version of the BODIS test is recommended (see below).

If the degradation process in question is intended to take place in anaerobic conditions or if conditions are likely to become anaerobic as a result of the degradation process, we recommend the use of the only existing standard test designed to test the biodegradability of chemicals under anaerobic conditions ((ISO CD 11734). This method is designed for use in fresh-water conditions and is not suitable for testing biodegradability under marine conditions.

We recommend the following biodegradability tests. The most appropriate test will depend on the environment in which the product is to be used and whether the pollutant is water- or fat-soluble:

Biodegradability:

Fresh-water environment:

–        OECD 301 D: Ready Biodegradability – Closed Bottle Method; the microbiological product is used as the inoculum and the pollutant as the test chemical.

–        ISO TC/147, SC5/WG4 N141-1990: Biological Oxygen Demand for Insoluble Substances (BODIS); the microbiological product is used as the inoculum and the pollutant as the test chemical. This method is designed for biodegradability marine conditions and substances that are insoluble in water. We also recommend this test for substances that are poorly soluble in water and intended for use in fresh-water conditions, but sea water should be replaced by fresh water. The BODIS test is in many respects similar to tests classified as Ready Biodegradability Tests, and the results will therefore be evaluated in the same way.

Marine environment:

–        OECD 306: Biodegradability in Seawater – Adapted Closed Bottle Method; the microbiological product is used as the inoculum and the pollutant as the test chemical. This test is in many respects similar to tests classified as Ready Biodegradability Tests, and the results will therefore be evaluated in the same way.

–        The BODIS test as described under Fresh-water environment.

Terrestrial environment:

–        OECD 301 D: Ready Biodegradability – Closed Bottle Method; the microbiological product is used as the inoculum and the pollutant as the test chemical. Despite the fact that the biodegradability is tested in an aqueous system, the test gives a good indication of biodegradability in a terrestrial environment. As far as we know, there is no corresponding simple standard test designed specially for soil.

–        The BODIS test as described under Fresh-water environment.

–        ISO CD 11734: Anaerobic Biodegradability; the microbiological product is used as the inoculum and the pollutant as the test chemical. This method was developed for fresh-water conditions, and is suitable for microbiological products designed for use in fresh water and soil. The results will be evaluated in the same way as for a Ready Biodegradability Test. The method cannot be adapted to marine conditions, because there are marked differences between anaerobic microbial processes in fresh-water and marine conditions. Since no satisfactory biodegradability test currently exists for anaerobic conditions in a marine environment, no specific test can be recommended for products intended for use under such conditions.

If the biodegradability test indicates that stable intermediate products are formed, the toxicity, bioaccumulation potential and carcinogenicity of the intermediate product(s) must be tested. This presupposes that the stable intermediate product has been identified and is available as a pure substance. If it is difficult to identify the intermediate product, some of the tests can be run at selected stages of the degradation process. However, this is not recommended, since fairly extensive changes to the standard tests are required and the results are therefore more uncertain.

Toxicity:

Most standardized toxicity tests are designed for water-soluble substances. However, the intermediate products formed during a degradation process may be poorly-soluble. In such cases, standard international practice is recommended. This involves extracting and testing the water-soluble fraction of the chemical (Girling, A. E., G. F. Whale, and D. M. M. Adema. A guideline supplement for determining the aquatic toxicity of poorly-soluble complex mixtures using water-accommodated fractions. Chemosphere, 29:2645-2649). We recommend the following as the first toxicity test:

–        MicrotoxTM: This method uses reduction of the fluorescence of the marine bacterium Photobacterium phosphoreum as a measure of toxicity. The intermediate product should be identified prior to testing. If this has not been done, the toxicity of the intermediate product may be measured by adding P. phosphoreum at selected points in time during the degradation process.

If the biodegradability test and the MicrotoxTM test indicate that stable, toxic intermediate products are formed, further toxicity testing of the intermediate products is required. Use of the tests recommended below will show whether or not the intermediate products have other or more toxic properties than the original compound. The test chosen will depend on the environment in which the microbiological product is to be used:

Fresh-water environment:

–        OECD 201: Tests the toxicity of the intermediate product(s) to a fresh-water alga such as Selenastrum capricornutum.

–        OECD 202: Tests the toxicity of the intermediate product(s) to a water flea such as Daphnia magna.

Marine environment:

–        ISO/DIS 10253: Tests the toxicity of the intermediate product(s) to the marine diatom Skeletonema costatum.

–        ISO TC 147/SC5/WG2: Tests the toxicity of the intermediate product(s) to the marine copepod Acartia tonsa.

Terrestrial environment:

–        OECD 207: Tests the toxicity of the intermediate product(s) to the earthworm Eisenia foetida.

–        OECD 208: Tests the toxicity of the intermediate product(s) to plants. The plants are weighed before and after exposure to the toxic intermediate product(s).

Bioaccumulation potential:

If the degradation process involves the formation of intermediate products that are not readily biodegradable, their bioaccumulation potential must be tested. The following method is recommended:

–        OECD 117: The partition coefficient between n-octanol and water (POW) is determined. The method is based on the fact that POW and accumulation in fish are closely correlated. In practice, the test is only suitable if the stable intermediate product has been identified and/or the pure substance is available.

Solubility in water:

Measurements of the solubility of the intermediate product(s) in water relative to that of the original substance are required. This makes it possible to use solubility in water as a measure of the mobility of the intermediate product compared with that of the original substance; the more soluble a substance, the more mobile it is. A comparatively soluble intermediate product will leach more easily into drinking water, for instance.

The following test is recommended:

–        OECD 105 (Water Solubility): Two variants of the method are available, depending on the solubility of the chemical in water. The column elution method is used for chemicals that are poorly soluble, and the bottle method for more soluble chemicals. The original pollutant and the intermediate product must both be available in pure form.

Carcinogenicity:

If stable intermediate products are formed, these shall be tested for carcinogenicity. The intermediate product must be available in pure form. One of the following tests is recommended:

–        OECD 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay) or the Ames test (Ames, B. 1979. Identifying environmental chemicals causing mutations and cancer. Science, 204: 587-593): Both methods are based on the theory that a mutagenic chemical is frequently carcinogenic as well. Procedures for both these tests are similar.

Chemical identity of the intermediate product:

If use of the microbiological product results in the formation of stable intermediate products with other or environmentally more harmful properties than the original pollutant, the intermediate product must be identified by a suitable method (e.g. HPLC, GC-MC).

If intermediate products with dangerous properties are formed, we require an assessment of whether the health and environmental hazard posed by the product is so great that the product should not be used.

Question 25. Can the product have undesirable effects on important natural microbial processes in the environment, for example nitrogen/phosphorus cycles and carbon mineralization, or by altering pH or oxygen concentration?

Give an account of whether the microbiological product can have undesirable effects on natural processes in the environment. This may be based on laboratory experiments, field studies and/or empirical data. Eutrophication caused by a product with an excessively high nitrogen and/or phosphorus content is one example of an undesirable effect. Some microbiological products might cause impoverishment of soils or water if the degradation process consumes salts and minerals that are naturally present in the environment. Use of a microbiological product could also cause local changes in pH or oxygen concentration.

Part 8 Other relevant information

Question 26. Give any other information in the form of empirical or test data that is relevant to the hazard to health or the environment posed by use of the microbiological product, and to which the importer/manufacturer has or should have access.

The importer/manufacturer is required to provide any information relevant to health and environmental hazards that has not been included in the answers to questions 1- 25.

Part 9 Overall assessment of risk to human health and the environment

Question 27 Give an overall assessment of the risk to human health and the environment posed by use of the product.

The manufacturer/importer is required to make an overall assessment of the health and environmental hazards posed by use of the product. This should be based on the information provided in the rest of the declaration.

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