Lexikon

2000/532/EC, commission decision of 3 May 2000 on the list of wastes.
List of wastes pursuant to Article 1(a) of Directive 75/442/EEC on waste and Article 1(4) of Directive 91/689/EEC on hazardous waste.
The present list is a harmonised list of wastes. It will be periodically reviewed and if necessary revised in accordance
with Article 18 of Directive 75/442/EEC. However, the inclusion of a material in the list does not mean that the
material is a waste in all circumstances. Materials are considered to be waste only where the definition of waste in
Article 1(a) of Directive 75/442/EEC is met. Wastes included in the list are subject to the provisions of Directive 75/442/EEC except where Article 2(1)(b) of this Directive applies.
The different types of waste in the list are fully defined by the six-digit code for the waste and the respective two-digit and four-digit chapter headings. This implies that the following steps should be taken to identify a waste in the list.
As the first step, identify the source generating the waste in Chapters 01 to 12 or 17 to 20 and identify the appropriate six-digit code of the waste. If no appropriate waste code can be found in Chapters 01 to 12 or 17 to 20 the Chapters 13, 14 and 15 must be examined to identify the waste. If none of these waste codes apply, the waste must be identified according to Chapter 16. If the waste is not in Chapter 16 either, the 99 code (wastes not otherwise specified) must be used in the section of the list corresponding to the activity identified in step one.
Any waste marked with an asterisk (*) is considered as a hazardous waste pursuant to Article 1(4), first indent, of
Directive 91/689/EEC on hazardous waste, and subject to the provisions of that Directive unless Article 1(5) of that
Directive applies.
For the purpose of this Decision, ‘dangerous substance’ means any substance that has been or will be classified as
dangerous in Directive 67/548/EEC as amended; ‘heavy metal’ means any compound of antimony, arsenic, cadmium,
chromium (VI), copper, lead, mercury, nickel, selenium, tellurium, thallium and tin, including these metals in metallic
form, as far as these are classified as dangerous substances. If a waste is identified as hazardous by a specific or general reference to dangerous substances, the waste is hazardous only if the concentrations of those substances are such (i.e. percentage by weight) that the waste presents one or more of the properties listed in Annex III to Council Directive 91/689/EEC.

Chapters of the list: two-digit codes:
01 Wastes resulting from exploration, mining, dressing and further treatment of minerals and quarry
02 Wastes from agricultural, horticultural, hunting, fishing and aquacultural primary production, food preparation and
processing
03 Wastes from wood processing and the production of paper, cardboard, pulp, panels and furniture
04 Wastes from the leather, fur and textile industries
05 Wastes from petroleum refining, natural gas purification and pyrolytic treatment of coal
06 Wastes from inorganic chemical processes
07 Wastes from organic chemical processes
08 Wastes from the manufacture, formulation, supply and use (MFSU) of coatings (paints, varnishes and vitreous
enamels), adhesives, sealants and printing inks
09 Wastes from the photographic industry
10 Inorganic wastes from thermal processes
11 Inorganic metal-containing wastes from metal treatment and the coating of metals, and non-ferrous hydrometallurgy
12 Wastes from shaping and surface treatment of metals and plastics
13 Oil wastes (except edible oils, 05 anbd 12)
14 Wastes from organic substances used as solvents (except 07 and 08)
15 Waste packaging; absorbents, wiping cloths, filter materials and protective clothing not otherwise specified
16 Wastes not otherwise specified in the list
17 Construction and demolition wastes (including road construction)
18 Wastes from human or animal health care and/or related research (except kitchen and restaurant wastes not arising
from immediate health care)
19 Wastes from waste treatment facilities, off-site waste water treatment plants and the water industry
20 Municipal wastes and similar commercial, industrial and institutional wastes including separately collected fractions.

Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:226:0003:0024:EN:PDF

directive 98/8/EC of the European Parliament and of the Council of 16 february 1998, concerning the placing of biocidal products on the market.

Biocidal products are active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.

Harmful is an organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment.

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Pursuant to Directive 98/8/EC, Member States may only authorise the placing on the market of biocidal products containing active substances included in Annex I, to that Directive.

Biocidal products containing active substances listed in Annex II to the Regulation 1451/2007 for which a decision was taken not to include these active substances for certain or all of their notified product types in Annex I (or IA) to Directive
98/8/EC, shall no longer be placed on the market.

Annex I and Annex II list can be find in: http://ecb.jrc.ec.europa.eu/legislation/2007R1451EC.pdf

Sourcec: http://ecb.jrc.ec.europa.eu/legislation/1998L0008EC.pdf, and
http://ecb.jrc.ec.europa.eu/legislation/2007R1451EC.pdf

the class of pesticides used to kill mites and ticks. Another name is miticide.

acid rain is a generic term used for precipitation that contains an high concentration of sulfuric and nitric acid. These acids form in the atmosphere when industrial gas emissions combine with water. Acidified particulate matter in the atmosphere is deposited by precipitation onto a surface, often eroding the surface away. This precipitation generally has a pH less than 5 and sometimes much lower depending on the concentration of acidic components. Acid rain has negative impacts on the environment and human health.

the lowering of soil and water pH due to acid precipitation and deposition usually through precipitation; this process disrupts ecosystem nutrient flows and may kill freshwater fish and plants dependent on more neutral or alkaline conditions See also acid rain

see as soil acidification

acute oral toxicity refers to those adverse effects occurring following oral administration of a single dose of a substance, or multiple doses given within 24 hours.

acute systemic toxicity testing is the estimation of the human hazard potential of a substance by determining its systemic toxicity in a test system (currently animals) following an acute exposure. Its assessment has traditionally been based on the median lethal dose (LD50) value - an estimate of the dose of a test substance that kills 50% of the test animals. For a substance to have systemic toxic effects it must be absorbed by the body and distributed by the circulation to sites in the body where it exerts toxic effects. The liver may transform a circulating drug or chemical to another form (biotransformation), and this new metabolite may be the one causing the observed toxicity.

Acute systemic toxicity is assessed following oral, dermal, and/or inhalation exposure(s) - depending upon the anticipated routes of human exposure to the substance. The Globally Harmonized System (GHS), which is scheduled for implementation in 2008, defines acute toxicity as "those adverse effects occurring following oral or dermal administration of a single dose of a substance, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours"

Sources:
UNECE, 2004, p. 109.
http://www.alttox.org/ttrc/toxicity-tests/acute/

short term toxicity. The adverse effects of chemical substances which result either from a single exposure or from multiple exposures in a short space of time.
In animal testings "acute" is the toxicity, when the adverse effects occurs within 14 days of the administration of the substance. In ecotoxicity testings acute toxicity is defined as a period of time shorter, than the generation time of the testorganism. The endpoints used for the quantitative characterisation of acute toxicity are: EC₅₀, LC₅₀ or ED₅₀ and LD₅₀ values.

Acute toxicity is distinguished from chronic toxicity, which describes the adverse health effects from repeated exposures, often at lower levels, to a substance over a longer time period months or years.

acute toxicity concerns the adverse effects, which may result from a single exposure or multiple exposures within 24 hours to a substance in toxicity tests. Exposure relates to the oral, dermal or inhalation routes. Assessment of the acute toxic potential of a chemical is necessary to determine the adverse health effects that might occur following accidental or deliberate short-term exposure: the types of toxic effects, their time of onset, duration and severity, the dose-response relationships, and the sex differences in response. The investigated damages can be clinical signs of toxicity, abnormal body weight changes, and/or pathological changes in organs and tissues, which in some cases may result in death.

Source: REACH

adenocarcinoma is a type of cancer that begins in cells that line the inside of organs. These organs make substances like hormones or milk. Most breast cancers are of this type. They begin in cells that make milk or in the cells that drain the breast milk.

See also breast cancer.

Source: http://www.breastcancer.org/dictionary/a/adenocarcinoma_t.jsp

a drug that kills cancer cells by stopping their growth. It can also make it hard for cancer cells to fix damage. It is a type of chemotherapy.

Brand name: Adriamycin

Chemical name: Doxorubicin

Class: anthracycline chemotherapy.

Doxil, daunorubicin, Ellence, and mitoxantrone are other anthracyclines.

How it works: Anthracyclines kill cancer cells by damaging their genes and interfering with their reproduction.

Uses: adriamycin usually is given in combination with other chemotherapy medicines. It's typically used: after surgery to reduce the risk of early-stage breast cancer coming back before surgery to shrink large advanced-stage breast cancer tumors to treat advanced-stage breast cancer

How it's given: adriamycin is given intravenously.

Additional information: Adriamycin can have a toxic effect on the heart. You should be tested for heart problems before starting to take Adriamycin and should be continuously monitored for developing problems during treatment.

Side effects:

• low white blood cell count
• increased risk of bleeding from low platelet count
• appetite changes
• nail changes
• hair loss
• nausea
• vomiting
• mouth sores
• heart problems
• hand-foot syndrome
• irregular periods -- this can include temporary cessation (usually resume after medication is completed) or permanent cessation of menstrual periods depending on your age and other factors

Source: http://www.breastcancer.org/treatment/druglist/adriamycin.jsp
See also: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682221.html

alpha-ketoglutaric acid bounds ammonia (in the form of α-ketoglutarate) produced by de-amination of glutamate. It plays important role in the Krebs-cycle, in the synthesis of amino-acid glutamine, in the ammonia-cycle. It is co-substrate for some oxigenase enzymes.

It is used as dietary supplement, mainly for body builders.

ASTM International is one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy.

Source: http://www.astm.org/

amino acids are molecules containing an amine group, a carboxylic acid group and a side chain that varies between different amino acids. Alpha-amino acids with the general formula H₂NCHRCOOH, where R is an organic substituent, play important role in the metabolism of living organisms. One particularly important function is as the building blocks of proteins, which are linear chains of amino acids. Every protein is chemically defined by this primary structure, its unique sequence of amino acid residues, which in turn define the three-dimensional structure of the protein.

Amino acids are synthesized from Glutamate, which is formed by amination of α-ketoglutarate:

α-Ketoglutarate + NH₄⁺ = Glutamate

Afterwards, Alanine and Aspartate are formed by transamination of Glutamate. All of the remaining amino acids are then constructed from Glutamate or Aspartate, by transamination of these two amino acids with one α-keto acid.

Humans are able to synthetise only part of the necessary amino-acids, 8 pf them are so calle essential aminoacids, which should be taken up by nutrition. The essential amino acids are: Isoleucine, Leucine, Lizyne, Methionine, Phenylalanine, Threonine, Tryptophane and Valine.

a body of surface water created by human activity.

American Standard Code for Information Interchange

Bactericides are substances that kill bacteria. Bactericides are either disinfectants, antiseptics or antibiotics. Bactericides are widely used in human and animal therapy, in agriculture plant pesticides and in different industries for killing harmful bacteria.

Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products was adopted in 1998. According to the Directive, Member States had to transpose the rules before 14 May 2000 into national law.

The Commission adopted the original proposal for the Directive in 1993. Directive 91/414/EEC on plant protection products, adopted in 1991, served as a model for the new Directive.

The Biocidal Product Directive aims to harmonise the European market for biocidal products and their active substances. At the same time it aims to provide a high level of protection for humans, animals and the environment.

biocides are defined in Article 2 (1) of the Biocidal Products Directive (98/8/EC) as:
"Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means."
Note, however, that many substances or preparations which meet this definition are excluded from the Biocidal Products Directive on the basis of being covered by other legislation such as the Plant Protection Products Directive (91/414/EEC) and many other Directives relating to veterinary medicines, proprietary medicinal products etc. Therefore, for a complete definition of a biocidal products you should consult the Biocidal Products Directive and its associated guidance.
In general terms, the scope of the Biocidal Products Directive is very wide, covering 23 different product types. This includes disinfectants for home and industrial use, preservatives for manufactured and natural products, non-agricultural pesticides for use against insects, rodents and other vertebrates and specialised products such as embalming/taxidermist fluids and antifouling products. A full list of product types is in Annex V of the BPD.
Under Article 15 (2) of the REACH Regulation, active substances which are regulated as biocides are regarded as being already registered under REACH.
Directive 98/8/EC, Articles 1 and 2.; REACH Article 15 (2).

carcinogen is a substance or a mixture of substances which induces cancer or increases its incidence (REACH).

Tghere are other definitions, such as the UNECE (2004) "The term carcinogen denotes a chemical substance or a mixture of chemical substances which induce cancer or increase its incidence".

An third alternate definition is that carcinogenic substances are ones that "induce tumors (benign or malignant), increase their incidence or malignancy, or shorten the time of tumor occurrence when they are inhaled, injected, dermally applied, or ingested".

Carcinogens are classified according to their mode of action as genotoxic or nongenotoxic carcinogens. Genotoxic carcinogens initiate carcinogenesis by direct interaction with DNA, resulting in DNA damage or chromosomal aberrations that can be detected by genotoxicity tests (OECD, 2006).

Nongenotoxic carcinogens are agents that, at least initially, directly internact with DNA. These indirect modifications to DNA structure, amount, or function may result in altered gene expression or signal transduction (OECD, 2006).

In animal studies, most potent mutagens are also found to be carcinogenic (Maurici, et al., 2005). Substances that induce tumors in animals are considered as presumed or suspected human carcinogens until convincing evidence to the contrary is presented (UNECE, 2004).

Sources:
REACH Glossary
http://alttox.org/ttrc/toxicity-tests/carcinogenicity/
UNECE, 2004
Maurici D, Aardema M, Corvi R, et al. (2005), “Carcinogenicity”. Alt Lab Anim Vol. 33 (Suppl 1): 177−182

carcinogenic effect has a substance or a mixture of substances which induces cancer or increases its incidence and/or malignancy or shorten the time to tumour occurrence. Causing cancer may be due to the ability to damage the genome or to the disruption of cellular metabolic processes. Carcinogenic chemicals have conventionally been divided into two categories according to the presumed mode of action. Non-genotoxic modes of action include epigenetic changes, i.e., effects that do not involve alterations in DNA but that may influence gene expression, altered cell-cell communication, or other factors involved in the carcinogenic process.

Cancer is a disorder of the cells, characterized by the lack of programmed cell death. Carcinogens induces the uncontrolled, malignant division pf cells, ultimately leading to the formation of tumors. Usually DNA damage leads to programmed cell death, but if the programmed cell death pathway is damaged, then the cell cannot prevent itself from becoming a cancer cell. The objective of investigating the carcinogenicity of chemicals is to identify potential human carcinogens, their modes of action, and their potency. Once a chemical has been identified as a carcinogen, there is a need to elucidate the underlying mode of action, i.e. whether the chemical is directly genotoxic or not. For genotoxic carcinogens it is assumed that, unless exception, there is no discernible threshold and that any level of exposure carries a risk. For non-genotoxic carcinogens, no-effect-thresholds are assumed to exist and to be discernable. Human studies are generally not available for making a distinction between the above mentioned modes of action; and a conclusion on this, in fact, depends on the outcome of mutagenicity testing and other mechanistic studies. In addition to this, animal studies may also inform on the underlying mode of carcinogenic action.

The cancer hazard and mode of action may also be highly dependent on exposure conditions such as the route of exposure. Therefore, all relevant effect data and information on human exposure conditions are evaluated.

in Annexes VII and VIII to Directive 79/831/EEC, methods for the determination of the ecotoxicity of chemical substances are enlisted. The methods are based on those recognized and recommended by competent international bodies (in particular OECD).

General introduction
1 acute toxicity for fish
2 acute toxicity for Daphnia
3 algal inhibition test
4 biodegradation: determination of the "ready" biodegradability
  4-a dissolved organic carbon (doc) die-away test
  4-b modified oecd screening test
  4-c carbon dioxide evolution test
  4-d manometric respirometry test
  4-e closed bottle test
  4-f miti test
5 degradation : biochemical oxygen demand
6 degradation: chemical oxygen demand
7 degradation: abiotic degradation: hydrolysis as a function of ph
8 toxicity for earthworms : artificial soil test
9 biodegradation: Zahn−Wellens test
10 biodegradation: activated sludge simulation test
11 biodegradation: activated sludge respiration inhibition test
12 biodegradation: modified scas test
13 bioconcentration: flow-through fish test
14 fish juvenile growth test
15 fish, short-term toxicity test on embryo and sac-fry stages
16 honeybees, acute oral toxicity test
17 honeybees, acute contact toxicity test
18 adsorption/desorption using a batch equilibrium method
19 estimation of the adsorption coefficient (koc) on soil and on sewage sludge using high performance liquid chromatography (hplc)
20 Daphnia magna reproduction test
21 soil microorganisms: nitrogen transformation test
22 soil microorganisms: carbon transformation test
23 aerobic and anaerobic transformation in soil
24 aerobic and anaerobic transformation in aquatic sediment systems

in Annexes VII and VIII to Directive 79/831/EEC, methods for the determination of the toxicity of chemical substances are enlisted. The methods are based on those recognized and recommended by competent international bodies (in particular OECD).

1 general introduction
1bis acute oral toxicity - fixed dose procedure
1tris acute oral toxicity - acute toxic class method
2 acute toxicity (inhalation)
3 acute toxicity (dermal)
4 acute toxicity: dermal irritation/corrosion
5 acute toxicity: eye irritation/corrosion
6 skin sensitisation
7 repeated dose (28 days) toxicity (oral)
8 repeated dose (28 days) toxicity (inhalation)
9 repeated dose (28 days) toxicity (dermal)
10 mutagenicity − in vitro mammalian chromosome aberration test)
11 mutagenicity − in vivo mammalian bone-marrow chromosome aberration test
12 mutagenicity mammalian erythrocyte micronucleus test
13/14 mutagenicity − reverse mutation test using bacteria
15 gene mutation − Saccharomyces cerevisae
16 mitotic recombination − Saccharomyces cerevisae
17 mutagenicity − in vitro mammalian cell gene mutation test
18 dna damage and repair − unscheduled dna synthesis − mammalian cells in vitro
19 sister chromatid exchange assay in vitro
20 sex-linked recessive lethal test in Drosophila melanogaster
21 in vitro mammalian cell transformation test
22 rodent dominant lethal test
23 mammalian spermatogonial chromosome aberration test
24 mouse spot test
25 mouse heritable translocation
26 sub-chronic oral toxicity test. Repeated dose 90-day toxicity study in rodents
27 sub-chronic oral toxicity test: repeated dose 90-day toxicity study in non-rodents
28 sub-chronic dermal toxicity test: 90-day repeated dermal dose study using rodent species
29 sub-chronic inhalation toxicity test: 90-day repeated inhalation dose study using rodent species
30 chronic toxicity test
31 teratogenicity test rodent and non-rodent
32 carcinogenicity test
33 combined chronic toxicity/carcinogenicity test
34 one-generation reproduction toxicity test
35 two generation reproduction toxicity test
36 toxicokinetics
37 delayed neurotoxicity of organophosphorus substances following acute exposure
38 delayed neurotoxicity of organophosphorus substances 28 day repeated dose study
39 unscheduled dna synthesis (uds) test with mammalian liver cells in vivo
40 skin corrosion (in vitro)
41 phototoxicity − in vitro 3t3 nru phototoxicity test
42 skin sensitisation: local lymph node assay
43 neurotoxicity study in rodents

Concise International Chemical Assessment Documents (CICAD). Concise documents that provide summaries of the relevant scientific information concerning the potential effects of chemical substances on human health and the environment; published by the IPCS (WHO International Programme on Chemical Safety).

circulating wells (CWs) provide a technique for subsurface remediation by creating a three-dimensional circulation pattern of the ground water. Ground Water is drawn into a well through one screened section and is pumped through the well to a second screened section where it is reintroduced to the aquifer. The flow direction through the well can be specified as either upward or downward to accommodate site-specific conditions. Because ground water is not pumped above ground, pumping costs and permitting issues are reduced and eliminated, respectively. Also, the problems associated with storage and discharge are removed. In addition to ground water treatment, CW systems can provide simultaneous vadose zone treatment in the form of bioventing or soil vapor extraction.

CW systems can provide treatment inside the well, in the aquifer, or a combination of both. For effective in-well treatment, the contaminants must be adequately soluble and mobile so they can be transported by the circulating ground water. Because CW systems provide a wide range of treatment options, they provide some degree of flexibility to a remediation effort.

Source: US-EPA, Clu-In: http://www.clu-in.org/techfocus/default.focus/sec/Ground-Water_Circulating_Wells/cat/Overview/

the cytoplasm is the part of a cell that is enclosed within the cell membrane. In eukaryotic cells, the contents of the cell nucleus are not part of the cytoplasm and are instead called the nucleoplasm. In eukaryotic cells, the cytoplasm contains organelles, such as mitochondria, Golgi, lysosomes and spherosomes. The cell organelles are filled with liquid that is kept separate from the rest of the cytoplasm by biological membranes. The cytoplasm is the site where most cellular activities occur, such as many metabolic pathways like glycolysis, and processes such as cell division. The inner, granular mass is called the endoplasm and the outer, clear and glassy layer is called the cell cortex or the ectoplasm.

The part of the cytoplasm that is not held within organelles is called the cytosol. The cytosol is a complex mixture of cytoskeleton filaments, dissolved molecules, and water that fills much of the volume of a cell. The cytosol is a gel, with a network of fibers dispersed through water. Due to this network of pores and high concentrations of dissolved macromolecules, such as proteins, an effect called macromolecular crowding occurs and the cytosol does not act as an ideal solution. This crowding effect alters how the components of the cytosol interact with each other.

(Crowding occurs since these high concentrations of macromolecules reduce the volume of solvent available for other molecules in the solution, which has the result of increasing their effective concentrations. This crowding effect can make molecules in cells behave in radically different ways than in test-tube assays. Consequently, measurements of the properties of enzymes or processes in metabolism that are made in the laboratory in dilute solutions may be different by many orders of magnitude from the true values seen in living cells. The study of biochemical processes under realistically crowded conditions is very important, since these conditions are a ubiquitous property of all cells and crowding may be essential for the efficient operation of metabolism.)

Source: Wikipedia

common technical specification is a technical specification drawn up in accordance with a procedure recognized by the Member States with a view to uniform application in all Member States and published in the Official Journal of the European Communities.

Source: Council Directive 93/38/EEC of 14 June 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0038:EN:HTML

conservation status of a species means the sum of the influences acting on the species concerned that may affect the long-term distribution and abundance of its populations within the territory referred to in Article 2;

The conservation status will be taken as "favourable" when:

- population dynamics data on the species concerned indicate that it is maintaining itself on a long-term basis as a viable component of its natural habitats, and

- the natural range of the species is neither being reduced nor is likely to be reduced for the foreseeable future, and

- there is, and will probably continue to be, a sufficiently large habitat to maintain its populations on a long-term basis.

Source: Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31992L0043:EN:html

it is a risk based target concentration for contaminated sites and contaminates soils. The Hungarian low requires the calculation of this target concentration in the remedial plan. The D-value is land-use specific.

a unit used to express relative difference on power, usually between acoustic or electric signals, equal to ten times the common logarithm of the ratio of the two level.

Read more:

http://www.animations.physics.unsw.edu.au/jw/dB.htm

see omega-3 fatty acids

ECOTOXICITY TESTING METHODS TO BE USED BY THE REACH REGULATION are enlisted in the COUNCIL REGULATION (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(1) Pursuant to Regulation (EC) No 1907/2006, test methods are to be adopted at Community level for the purposes of tests on substances where such tests are required to generate information on intrinsic properties of substances.

(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances laid down, in Annex V, methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations. Annex V to Directive 67/548/EEC has been deleted by Directive 2006/121/EC of the European Parliament and of the Council with effect from 1 June 2008.

(3) The test methods contained in Annex V to Directive 67/ 548/EEC should be incorporated into this Regulation.

(4) This Regulation does not exclude the use of other test methods, provided that their use is in accordance with Article 13(3) of Regulation 1907/2006.

(5) The principles of replacement, reduction and refinement of the use of animals in procedures should be fully taken into account in the design of the test methods, in particular when appropriate validated methods become available to replace, reduce or refine animal testing.

(6) The provisions of this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006

Article 1: The test methods to be applied for the purposes of Regulation 1907/2006/EC are set out in the Annex to this Regulation.

Article 2: The Commission shall review, where appropriate, the test methods contained in this Regulation with a view to replacing, reducing or refining testing on vertebrate animals.

Article 3: All references to Annex V to Directive 67/548/EEC shall be construed as references to this Regulation.

Article 4: This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.

It shall apply from 1 June 2008.

LIST OF METHODS FOR THE DETERMINATION OF ECOTOXICITY

C.1. Acute toxicity for fish
C.2. Daphnia sp. Acute immobilisation test
C.3. Algal inhibition test
C.4. Determination of ‘ready’ biodegradability
Part i. General considerations
Part ii. Doc die-away test (method C.4-a)
Part iii. Modified oecd screening test (method C.4-b)
Part iv. Co2 evolution test (method C.4-c)
Part v. Manometric respirometry test (method C.4-d)
Part vi. Closed bottle test (method C.4-e)
Part vii. M.I.T.I. Test (method C.4-f)
C.5. Degradation — biochemical oxygen demand
C.6. Degradation — chemical oxygen demand
C.7. Degradation — abiotic degradation: hydrolysis as a function of ph
C.8. Toxicity for earthworms
C.9. Biodegradation — Zahn-Wellens test
C.10. Biodegradation — activated sludge simulation tests
C.11. Biodegradation — activated sludge respiration inhibition
C.12. Biodegradation — modified SCAS test
C.13. Bioconcentration: flow-through fish test
C.14. Fish juvenile growth test
C.15. Fish, short-term toxicity test on embryo and sac-fry stages
C.16. Honeybees — acute oral toxicity test
C.17. Honeybees — acute contact toxicity test
C.18. Adsorption/desorption using a batch equilibrium method
C.19. Estimation of the adsorption coefficient (koc) on soil and on sewage sludge using high performance liquid chromatography (HPLC)
C.20. Daphnia magna reproduction test
C.21. Soil microorganisms: nitrogen transformation test
C.22. Soil microorganisms: carbon transformation test
C.23. Aerobic and anaerobic transformation in soil
C.24. Aerobic and anaerobic transformation in aquatic sediment systems

see omega-3 fatty acids

the percentage of total energy input that does useful work and is not lost or converted to low temperature, usually useless, heat.