Lexikon
REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment.
In principle REACH applies to all chemicals: not only chemicals used in industrial processes but also in our day-to-day life, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances.
The aims of REACH are to:
- Improve the protection of human health and the environment from the risks that can be posed by chemicals
- Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU
- Promote alternative methods for the assessment of hazards of substances
- Ensure the free circulation of substances on the internal market of the European Union.
Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF
means all manufacturers and/or importers and/or downstream users in a supply chain.
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
within the context of REACH, an additive is a compound that has been intentionally added during the manufacturing process to stabilise the substance. Under other legislation additive can have other functions, e.g. pH-regulator or colouring agent.
In REACH the term "additive" can also have other meanings outside the context of substance identification, for instance in relation to food or feed additives. (See REACH, article 2)
(Source: REACH Glossary)
Annex XIII contains criteria for the identification of persistent, bioaccumulative and toxic (PBT) substances, and very persistent and very bioaccumulative substances (vPvB).
Source: REACH
Annex XIV: Authorisation Priority List, contains the substances which are subject of authorisation and the specific timeline for sunsetting & application.
Source: REACH
Annex XV dossiers are the regulatory instruments for the Authorities (Member States or the Agency) to propose and justify:
- a harmonised classification and labelling of substances as carcinogenic, mutagenic and or toxic to reproduction (CMR) and as respiratory sensitisers, or for any other endpoint if justification for action at Community level can be provided. Agreement on a dossier for harmonised classification and labelling will lead to the addition of the classification to Annex I of Directive 67/548/EEC.
- the identification of CMR substances, PBT substances, vPvB substances or substances of an equivalent level of concern. Agreement on the identification of a substance as a PBT, vPvB or of an equivalent level of concern means that it is a substance of very high concern and is to be included in the candidate list of substances for eventual inclusion in Annex XIV of the REACH Regulation, and through this be subject to authorisation. Substances with PBT or vPvB properties, wide dispersive use or high volumes will be priority substances for inclusion in Annex XIV.
- Restriction on the manufacture, placing on the market or use of substances within the Community. Agreement on proposed restrictions will lead to the addition of any agreed restrictions to Annex XVII of the REACH Regulation. Any subsequent manufacture, placing on the market or use of the substance has to comply with the conditions of the restrictions.
Annex XV of the REACH Regulation lays down general principles for preparing these three types of dossier.
Source: REACH
Annex XVI is the socio-economic analysis of the substance in question.
Annex XVII contains restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles.
Source: REACH
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 BMD concept involves fitting a mathematical model to dose-response data. The BMD is defined as the dose causing a predetermined change in response.
The BMD10 Benchmark-dose associated with a 10% response (for tumours upon lifetime exposure after correction for spontaneous incidence, for other effects in a specified study.
The BMDL10 is the lower 95% confidence interval of a Benchmark-dose representing a 10% response (e.g., tumour response upon lifetime exposure), i.e. the lower 95% confidence interval of a BMD10. (Source: REACH Glossary)
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).
CARACAL is an expert group giving advice for the European Commission and ECHA (European Chemicals Agency) on questions related to REACH and CLP. It was founded as "European Commission Working Group on the Practical Preparations for REACH" in May 2004. As of September 2007, it was re-named into "REACH Competent Authorities (REACH CA)" and, as of March 2009, into "Competent Authorities for REACH and CLP (CARACAL)".
See also: http://ec.europa.eu/enterprise/sectors/chemicals/reach/caracal/index_en.htm
Chemical Safety Assessment is the process aimed at determining the risk posed by a substance and, as part of the exposure assessment, develop exposure scenarios including risk management measures to control the risks. Annex I contains general provisions for performing a CSA. The CSA consists of the following steps:
- Human health hazard assessment
- Human health hazard assessment of physicochemical properties
- Environmental hazard assessment
- PBT and vPvB assessment
If, as a result of this hazard assessment, the registrant concludes that the substance meets the criteria for classification as dangerous according to Directive 67/548/EEC (for substances) or has PBT/vPvB properties, this triggers further steps in the chemical safety assessment:
- exposure assessment
- risk characterization.
(Source: REACH Glossary)
the chemical safety report documents the chemical safety assessment for a substance on its own, in a preparation or in an article or a group of substances.
In other words the Chemical Safety Report (CSR) is a document, which details the process and the results of a Chemical Safety Assessment (CSA). Annex I of the REACH Regulation contains general provisions for performing CSAs and preparing CSRs. (Source: REACH Glossary)
chemical substances with carcinogenic, mutagenic or toxic effect to reproduction. The abbreviation of CMR is used for the characterisation of chemical substances with these properties. Consequences and obligations of being CMR are given by REACH.
REACH requires that manufacturers/importers of the same substance cooperate jointly in preparing a submission, by sharing data and costs. Consortia are an efficient form of cooperation for potential registrants of a substance or group of substances to fulfil the REACH requirements in time.
ReachCentrum manages a large number of REACH consortia. ReachCentrum Consortium Management Services are designed for companies preparing, forming and operating REACH consortia. A good management practice is able to simplify the processes of forming and maintaining REACH consortia with the focus on meeting the REACH registration deadlines in time and cost efficiently.
for non-threshold effects, the underlying assumption is that a no-effect-level cannot be established and a DMEL therefore expresses an exposure level corresponding to a low, possibly theoretical, risk, which should be seen as a tolerable risk. (Source: REACH Glossary)
The principal legislation currently in the European Union (EU) (formerly the European Community (EC) and before that the European Economic Community (EEC)) relating to the Classification, Packaging and Labelling of dangerous substances and preparations was, until January 2009, that of the 67/548/EEC Dangerous Substances Directive (DSD), which, as a Directive, Member States had to implement by passing national legislation. The DSD also contained new substance notification requirements but from June 2008 these were revoked and replaced by the directly acting REACH Regulation. The DSD also contained a requirement to supply Safety Data Sheets for substances, but REACH took over this requirement from June 2008. The detailed SDS requirements were subject to the 91/155/EC Safety Data Sheet Directive (SDSD), but this was also revoked and replaced, with effect from 1 June 2007, by REACH. To prevent preparations having to be classified by testing in the same way as substances, the 1999/45/EC Dangerous Preparations Directive (DPD) was introduced to provide an alternative conventional (mathematical) system for classification. The DPD also contains special packaging and special labelling requirements for certain preparations. The DPD also used to contain a requirement for the supply of SDSs, but this was revoked, with effect from 1 June 2007, by REACH.
Source: http://www.chcs.org.uk/chemical-hazards-legislation-international.htm
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
The Exposure Information required for substances registered in the 1 to 10 tonne band is defined in Annex VI, 6, of REACH, and is given in the table below.
This information is required in place of the CSR which is required for substances in higher tonnage bands.
| Annex VI clause | Exposure Information required |
| 6.1 | Main use category |
6.1.1 | (a) Industrial use; (b) Professional; (c) Consumer use |
6.1.2 | Specification for industrial and professional use: |
| 6.2 | Significant routes of exposure |
6.2.1 | Human exposure: (a) oral; (b) dermal; (c) inhalatory. |
6.2.2 | Environmental exposure: (a) water; (b) air; (c) solid waste; (d) soil. |
| 6.3 | Pattern of exposure: (a) accidental; (b) occasional; (c) continuous/frequent |
Source: http://www.reach-serv.com/index.php?option=com_content&task=view&id=160&Itemid=64
set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control exposure of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate. Source: REACH Glossary
the type of hazard is described by hazard classes. Generally these are subdivided into hazard categories which express the level of hazardousness.
Altogether the GHS comprises 16 classes for physical-chemical hazards, 10 classes for health hazards, and one class for hazards to the aquatic environment.
http://ec.europa.eu/competition/mergers/cases/index/nace_all.html
the Industry Category indicates in which sectors of economy (including private household and public domain) the substance is used. This descriptor is based on the NACE system. (Source: REACH Glossary)
Specifically for the information requirements on inherent properties: The amount and type of information required is principally dependant on the tonnage threshold but can also be affected by other factors like its use and exposure characteristics. For substances manufactured or imported in quantities between 1 and 10 tonnes the specific information requirements can also be affected by whether the substance is classed as "phase-in".
The standard information requirements for each tonnage band are presented in Annexes VII to X of the Regulation. (Source: REACH Glossary)
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)
a company which submits registration information to the Agency on behalf of other members of a joint registration. The information submitted by the lead registrant concerns classification and labelling, study summaries, test proposals and, if necessary, indication which of the information was reviewed by an assessor. If the members of the joint registration so decide, the lead registrant may also submit information on safe use and the CSR on behalf of the others. After the lead registrant submits the information, the other members of the joint registration submit the remaining information individually. (Source: REACH Glossary)
The information required regarding manufacture and use of a substance is defined in Annex VI, 3, of REACH. It includes:
- Estimated total quantity manufactured, used in articles (subject to registration), and/or imported in tonnes/year (per registrant) in the calendar year of registration;
- Brief description of the process used in manufacture or production of articles (where relevant);
- Tonnage used for registrant’s own use;
- Form (substance, preparation or article) and/or physical state in which the substance is provided to downstream users, including,
- Concentration (range) in preparations;
- Quantities in articles;
- General description of identified uses;
- Information on waste quantities and composition form manufacture, use in articles and other identified uses.
- Uses advised against.
Source: http://www.reach-serv.com/index.php?option=com_content&task=view&id=160&Itemid=64
A NLP is a substance which was considered as notified under Article 8 (1) of the 6th amendment of Directive 67/548/EEC (and hence did not have to be notified under that Directive), but which does not meet the REACH definition of a polymer (which is the same as the polymer definition introduced by the 7th amendment of Directive 67/548/EEC) (Source: REACH)
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.9. Flash-point
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)
Under Directive 67/548/EEC these are standard phrases indicating the special risks arising from the dangers involved in using the substance or preparation. For example "Danger of very serious irreversible effects", "Limited evidence of a carcinogenic effect". When the current provisions are repealed and GHS enters into force, the R-phrases will be replaced by "hazard statements". (Source: REACH Glossary)
The concrete risk-phrases are enlisted in the entry of verbal characterisation of risk of chemicals