the REACH Regulation sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorisation requirement. Such substances are included in Annex XIV of the Regulation, and may not be placed on the market or used without an authorisation.This authorisation requirement ensures that risks from the use of such substances are either adequately controlled or outweighed by socio-economic benefits. An analysis of alternative substances or technologies will be a fundamental component of the authorisation process. Source: REACH Glossary
The similarities may be based on the following:
a) common functional group(s) (e.g. aldehyde, epoxide, ester, specific metal ion)
b) common constituents or chemical classes, similar carbon range numbers. This is frequently the case with complex substances often known as “substances of Unknown or Variable composition, Complex reaction products or Biological material” (UVCB substances)
c) an incremental and constant change across the category (e.g. a chain-length category), often observed in physicochemical properties, e.g. boiling point range
d) the likelihood of common precursors and/or breakdown products, via physical or biological processes, which result in structurally similar chemicals (e.g. the “metabolic pathway approach” of examining related chemicals such as acid/ester/salt). (Source: REACH Glossary)
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).
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 physico-chemical properties of chemical substances are enlisted. The methods are based on those recognized and recommended by competent international bodies (in particular OECD).
1 melting/freezing temperature
2 boiling temperature
3 relative density
4 vapour pressure
5 surface tension
6 water solubility
8 octanol−water partition coefficient
10 flammability (solids)
11 flammability (gases)
12 flammability (contact with water)
13 pyrophoric properties of solids and liquids
14 explosive properties
15 auto-ignition temperature (liquids and gases)
16 relative self-ignition temperature for solids
17 oxidizing properties (solids)
18 number - average molecular weight and molecular weight distribution of polymers
19 low molecular weight content of polymers
20 solution / extraction behaviour of polymers in water
21 oxidising properties (liquids)
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
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
classification is the process in which a given substance or preparation is assigned one of the 15 categories of danger depending on their intrinsic properties in accordance with the criteria for specified in directive 67/548/EEC. If the substance is not found to be dangerous, according to the said criteria, then it is not classified. Under GHS the substance or preparation will be assigned to hazard classes.
the action undertaken by the European Community in the field of chemical products is part of an ongoing process launched a long time ago. The first Directive, which is concerned with the classification, packaging and labelling of dangerous substances, dates back to 1967. The REACH (Registration, Evaluation, Authorisation and Restrictions of Chemicals) Regulation, adopted at the end of 2006, establishes an enhanced framework which aims to guarantee the free movement of chemical products and the protection of human health and the environment.
- DANGEROUS SUBSTANCES AND PREPARATIONS
- Regulatory framework for the management of chemicals (REACH), European Chemicals Agency
- Classification, packaging and labeling of chemicals and their mixtures
- Classification, packaging and labelling of dangerous substances
- Classification, packaging and labelling of dangerous preparations
- Prior Informed Consent Procedure for the export of chemicals
- Community strategy for endocrine disrupters, COM/99/0706 and COM/2001/0262
- Community strategy concerning mercury
- Export and storage of mercury
- CONTROL OF THE RISKS
- MANAGEMENT OF POLLUTANTS AND WASTE
- Convention on Long-Range Transboundary Air Pollution
- Elimination and minimisation of production, use and release of persistent organic pollutants (POPs)
- Controlled management of hazardous waste (until the end of 2010)
- Basel Convention
- Community strategy for dioxins, furans and PCBs
- Disposal of polychlorinated biphenyls (PCBs) and polychlorinated terphenyls (PCTs)
an intrinsic property of a chemical substance is a characteristic of the substance which can be used to determine its fate or to identify potential hazards. In order to register a substance under REACH, the registrant must submit specific information about the intrinsic properties of the substance in each of the following areas:
- physical/chemical properties
- human toxicological information
- ecotoxicological information
Data on the intrinsic properties of a substance are categorised into endpoints. For instance, “carcinogenicity” is a human toxicological endpoint.(Source: REACH Glossary)
different systems of classification and labelling C&L of chemicals are currently used throughout the world. The same substance may be classified as “toxic” in the United States, “harmful” in the European Union and “not dangerous” in China. To eliminate these disparities and to reinforce protection for people and the environment in all countries, it was decided to develop a Globally Harmonised classification and labelling System GHS under the aegis of the United Nations. The GHS was formally adopted in 2002 by the United Nations Economic and Social Committee UN ECOSOC and revised in 2005 and 2007.
It aims to improve the communication on hazards for workers, consumers, emergency responders and in transport, via harmonised labels and where relevant, harmonised safety data sheets.
European Commission adopted in late 2008 the so called "CLP" regulation EC No 1272/2008 on classification, labelling and packaging of hazardous substances and mixtures, which will replace in the medium term the current system.
This regulation takes into account the classification criteria and labelling rules of the GHS but it is also built on the 40 years of experience obtained through implementation of existing Community chemicals legislation.
Source: REACH, http://www.prc.cnrs-gif.fr/reach/en/classification.html
hysico-chemical testing methods for chemical substances: 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 PHYSICO-CHEMICAL PROPERTIES OF CHEMICAL SUBSTANCES
A.1. Melting/freezing temperature
A.2. Boiling temperature
A.3. Relative density
A.4. Vapour pressure
A.5. Surface tension
A.6. Water solubility
A.8. Partition coefficient
A.10. Flammability (solids)
A.11. Flammability (gases)
A.12. Flammability (contact with water)
A.13. Pyrophoric properties of solids and liquids
A.14. Explosive properties
A.15. Auto-ignition temperature (liquids and gases)
A.16. Relative self-ignition temperature for solids
A.17. Oxidising properties (solids)
A.18. Number – average molecular weight and molecular weight distribution of Polymers
A.19. Low molecular weight content of polymers
A.20. Solution/extraction behaviour of polymers in water
A.21. Oxidising properties (liquids)
use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation.
Conditions of use refer to the Operational Conditions and Risk Management Measures (RMM) as described in an Expousre Scenarios.
(Source: REACH Glossary)