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
(a) harmonised classification and labelling of CMRs, respiratory sensitisers and other effects
(b) the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern
(c) restrictions of the manufacture, placing on the market or use of a substance within the community.
Proposals for restrictions and identification of substances of very high concern can be prepared by a Member State Competent Authority or by the Agency on a request from the Commission. Proposals for harmonised classification and labelling can be prepared by a Member State Competent Authority. Source: REACH Glossary
Collection of the definitions of expressions used by REACH. http://REACH.jrc.it/public-2/glossary.htm
in connection with REACH you can find user-friendly information on the website http://reach-support.com/
The information required in technical dossiers is dependant on the annual tonnage of the substance, and is specified in Annexes VI-X of REACH. It includes:
- Registrant details;
- Joint submission details;
- Third party representatives;
- Substance identity;
- Manufacture and use;
- Classification and labelling;
- Guidance on safe use;
- Exposure information (1 to 10 tonne band only);
- (Robust) study summaries reporting on the physiochemical, toxicological, and ecotoxicological properties of the substance;
- Proposals for additional testing;
- Justification to keep commercially sensitive information out of the public domain.
Annex VI specifies the general information which must be provided for all substances regardless of tonnage.
Annexes VII to X give details of the physicochemical, toxicological and ecotoxicological properties that must be provided for each tonnage band.
Annex XV of the REACH regulation lays down general principles for preparing Annex XV dossiers to propose and justify
(a) harmonised classification and labelling of CMRs, respiratory sensitisers and other effects
(b) the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern
(c) restrictions of the manufacture, placing on the market or use of a substance within the community.
Proposals for restrictions and identification of substances of very high concern can be prepared by a Member State Competent Authority or by the Agency on a request from the Commission. Proposals for harmonised classification and labelling can be prepared by a Member State Competent Authority.
(Source: REACH)
REACH REGULATION, TABLE OF CONTENTS
TITLE I GENERAL ISSUES
Chapter 1 Aim, scope and application
Chapter 2 Definitions and general provision
TITLE II REGISTRATION OF SUBSTANCES
Chapter 1 General obligation to register and information requirements
Chapter 2 Substances regarded as being registered
Chapter 3 Obligation to register and information requirements for certain types of isolated intermediates
Chapter 4 Common provisions for all registrations
Chapter 5 Transitional provisions applicable to phase-in substances and notified substances
TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
Chapter 1 Objectives and general rules
Chapter 2 Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
Chapter 3 Rules for phase-in-substances
TITLE IV INFORMATION IN THE SUPPLY CHAIN
TITLE V DOWNSTREAM USERS
TITLE VI EVALUATION
Chapter 1 Dossier evaluation
Chapter 2 Substance evaluation
Chapter 3 Evaluation of intermediates
Chapter 4 Common provisions
TITLE VII AUTHORISATION
Chapter 1 Authorisation requirement
Chapter 2 Granting of authorisations
Chapter 3 Authorisations in the supply chain
TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES & PREPARATIONS
Chapter 1 General issues
Chapter 2 Restrictions process
TITLE IX FEES AND CHARGES
TITLE X AGENCY
TITLE XI CLASSIFICATION AND LABELLING INVENTORY
TITLE XII INFORMATION
TITLE XIII COMPETENT AUTHORITIES
TITLE XIV ENFORCEMENT
TITLE XV TRANSITIONAL AND FINAL PROVISIONS
ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)
ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)
ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE
ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE
ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE
ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE
ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X
ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ANNEX XV DOSSIERS
ANNEX XVI SOCIO-ECONOMIC ANALYSIS
ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLE
registration is the submission to the Agency of a technical dossier and, if required, a chemical safety report for a substance being manufactured in or imported into the European Union (and in the European Economic Area (EEA) once implemented in these countries). (Source: REACH Glossary)
registration is the submission to the Agency of a technical dossier and, if required, a chemical safety report for a substance being manufactured in or imported into the European Union (and in the European Economic Area (EEA) once implemented in these countries).
Manufacturers or Importers of substances on their own or in preparations or Producers or importers of articles will have in certain circumstances to provide a registration dossier to the European Chemicals Agency according to Articles 10, 11, 12, 17 and 18. It consists of a technical dossier and, when required, a Chemical Safety Report. (Source: REACH Glossary)
the repeated dose toxicity comprises the general toxicological effects occurring as a result of repeated daily exposure to a substance for a part of the expected lifespan (sub-acute or sub-chronic exposure) or for the major part of the lifespan (chronic exposure).
These general toxicological effects include effects on body weight and/or body weight gain, absolute and/or relative organ and tissue weights, alterations in clinical chemistry, urinalysis and/or haematological parameters, functional disturbances in the nervous system as well as in organs and tissues in general, and pathological alterations in organs and tissues as examined macroscopically and microscopically. Besides this information on possible adverse general toxicological effects, repeated dose toxicity studies may also provide other information on e.g. reproductive toxicity or carcinogenicity or may identify specific manifestations of toxicity such as e.g., neurotoxicity, immunotoxicity, endocrine-mediated effects...
The objectives of assessing repeated dose toxicity are to evaluate:
- whether repeated exposure of humans to a substance has been associated with adverse toxicological effects; these human studies potentially may also identify populations that have higher susceptibility;
- whether repeated administration of a substance to experimental animals causes adverse toxicological effects; effects that are predictive of possible adverse human health effects;
- the target organs, the potential cumulative effects and the reversibility of the adverse toxicological effects;
- the dose-response relationship and the threshold for any of the adverse toxicological effects observed in the repeated dose toxicity studies;
Source: REACH
reproductive toxicity is of obvious high concern because the continuance of the human species is dependent on the integrity of the reproductive cycle. It is characterised by multiple diverse endpoints, such as impairment of male and female reproductive functions or capacity (fertility), induction of non-heritable harmful effects on the progeny (developmental toxicity) and effects on or mediated via lactation.
The objectives of assessing reproductive toxicity are to establish:
- whether exposure of humans to the substance of interest has been associated with reproductive toxicity;
- whether, on the basis of information other than human data, it can be predicted that the substance will cause reproductive toxicity in humans;
- whether the pregnant female is potentially more susceptible to general toxicity;
- the dose-response relationship for any adverse effects on reproduction.
Source: REACH
the Committee for risk Assessment (RAC) is an Agency committee that is responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions and proposals for classification and labelling under the classification and labelling inventory task and any other questions that arise from the operation of this Regulation relating to risks to human health or the environment. The RAC consists of at least one but no more than two members from the nominees of each Member State appointed by the Management Board for a renewable term of three years. The Committee members may be accompanied by advisers on scientific, technical or regulatory matters.
(Source: REACH)
Information provided on substance properties derived from testing (or otherwise), should be supported by sufficient information to show that the results are valid and reliable. Data should be traceable and validated.
REACH refers to study summaries and robust study summaries which it defines as:
Study summary: A summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study.
Robust study summary: A detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report.
A robust study summary is more detailed than a study summary, but even these definitions do not really clearly define the boundary between them. It will be ECHA and the MSCAs during the evaluation process who make the final decision on whether enough information has been provided.
IUCLID 5 contains input fields for (robust) study summaries data. It also asks for a confidence rating in the results of the study. Not all data will carry the same weight. It is also possible to attach the full study to the IUCLID file, but this should be done in addition to completing the data entry fields, not instead of.
Source: http://www.reach-serv.com/index.php?option=com_content&task=view&id=160&Itemid=64
standard phrases relating to the safe use of dangerous chemical substance. For example "Keep container tightly closed" or "avoid contact with skin" or "do not empty into drains". When the current provisions are repealed and GHS enters into force, the S-phrases will be replaced by "precautionary statements". (Source: REACH Glossary).
The S-phrases are enlisted under the entry of "safety advice for the use of dangerous substances".
the safety data sheet is the main tool used in industry for communicating information on the hazard of dangerous substances and preparations through the supply chain. Annex II of REACH is based on the Annex to the safety data sheet Directive (91/155/EEC) and explains what information should be included under each of the 16 safety data sheet headings. (Source: REACH Glossary)
according to REACH definition, an eye damage is serious the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.
The information required to identify a substance is defined in Annex VI, 2, of REACH, and is reproduced in the table below.
If it is not technically possible, or does not appear scientifically necessary to provide certain information, the reasons should be stated.
If you are involved in a joint registration, it is very important that you have agreed ‘sameness’ of your substances, and the information you each provide here should support this. There is no legal definition of "sameness" but any inconsistencies identified by ECHA or MSCAs that suggest your substances are significantly different could lead to requests for further information, or rejection of registration dossiers.
ECHA Technical Guidance: Guidance for identification and naming of substances under REACH
| Annex VI clause | Information requirement |
| 2.1 | Name or other identifier of the substance |
2.1.1 | IUPAC name or other international chemical name |
2.1.2 | Other names, e.g. trade name, abbreviation |
2.1.3 | EC Number |
2.1.4 | CAS name and CAS number |
2.1.5 | Other identity code |
| 2.2 | Information related to molecular and structural Formula |
2.2.1 | Molecular and structural formula (including SMILES notation, if available) |
2.2.2 | Optical activity and typical ratio of (stereo) isomers ( if applicable and appropriate) |
2.2.3 | Molecular weight or molecular weight range |
| 2.3 | Composition |
2.3.1 | Degree of purity |
2.3.2 | Nature of impurities, including isomers and by-products |
2.3.3 | Percentage of (significant) main impurities |
2.3.4 | Nature and order of magnitude (…ppm, …%) of any additives |
2.3.5 | Spectral data (UV,IR,NMR or mass spectrum) |
2.3.6 | High pressure liquid chromatogram, gas chromatogram. |
2.3.7 | Description of the analytical methods or the appropriate bibliographical references fro the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced. |
Source: http://www.reach-serv.com/index.php?option=com_content&task=view&id=160&Itemid=64
data sharing is one of the core principles in the REACH Regulation. By submitting dossiers jointly and sharing information on substances, companies increase the efficiency of the registration system, reduce costs and avoid unnecessary testing on vertebrate animals.
A potential registrant can choose to request data which does not involve testing on vertebrate animals. However, the potential registrant must request data which involves testing on vertebrate animals.
Indeed, studies involving testing on vertebrate animals have to be shared in any case.
This means that new studies involving vertebrate animals can only be conducted if the data cannot be generated by any other means. This principle is valid for both phase-in and non- phase-in substances.
Source: http://echa.europa.eu/datasharing_en.asp
In addition, the term technical dossier is also used to refer to one of the two parts of the Annex XV dossier. It supports the Annex XV report.(Source: REACH Glossary)
the testing of physico-chemical characteristics of chemical substances is regulated by 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 TOXICITY
B.1 bis. Acute oral toxicity – fixed dose procedure
B.1 tris. Acute oral toxicity – acute toxic class method
B.2. Acute toxicity (inhalation)
B.3. Acute toxicity (dermal)
B.4. Acute toxicity: dermal irritation/corrosion
B.5. Acute toxicity: eye irritation/corrosion
B.6. Skin sensitisation
B.7. Repeated dose (28 days) toxicity (oral)
B.8. Repeated dose (28 days) toxicity (inhalation)
B.9. Repeated dose (28 days) toxicity (dermal)
B.10. Mutagenicity – in vitro mammalian chromosome aberration test
B.11. Mutagenicity – in vivo mammalian bone marrow chromosome aberration test
B.12. Mutagenicity – in vivo mammalian erythrocyte micronucleus test
B.13/14. Mutagenicity: reverse mutation test using bacteria
B.15. Mutagenicity testing and screening for carcinogenicity gene mutation – saccharomyces cerevisiae
B.16. Mitotic recombination – saccharomyces cerevisiae
B.17. Mutagenicity – in vitro mammalian cell gene mutation test
B.18. Dna damage and repair – unscheduled dna synthesis – mammalian cells in vitro
B.19. Sister chromatid exchange assay in vitro
B.20. Sex-linked recessive lethal test in drosophila melanogaster
B.21. In vitro mammalian cell transformation tests
B.22. Rodent dominant lethal test
B.23. Mammalian spermatogonial chromosome aberration test
B.24. Mouse spot test
B.25. Mouse heritable translocation
B.26. Sub-chronic oral toxicity test repeated dose 90-day oral toxicity study in rodents
B.27. Sub-chronic oral toxicity test repeated dose 90-day oral toxicity study in nonrodents
B.28. Sub-chronic dermal toxicity study 90-day repeated dermal dose study using
Rodent species
B.29. Sub-chronic inhalation toxicity study 90-day repeated inhalation dose studusing rodent species
B.30. Chronic toxicity test
B.31. Prenatal developmental toxicity study
B.32. Carcinogenicity test
B.33. Combined chronic toxicity/carcinogenicity test
B.34. One-generation reproduction toxicity test
B.35. Two-generation reproduction toxicity study
B.36. Toxicokinetics
B.37. Delayed neurotoxicity of organophosphorus substances following acute exposure
B.38. Delayed neurotoxicity of organophosphorus substances 28 day repeated dose study
B.39. Unscheduled dna synthesis (uds) test with mammalian liver cells in vivo
B.40. In vitro skin corrosion: transcutaneous electrical resistance test (ter)
B.40 bis. In vitro skin corrosion: human skin model test
B.41. In vitro 3T3 NRU phototoxicity test
B.42. Skin sensitisation: local lymph node assay
B.43. Neurotoxicity study in rodents
B.44. Skin absorption: in vivo method
B.45. Skin absorption: in vitro method
the expression of toxicity arising from exposure to a substance is a consequence of a chain of events that results in the affected tissues of an organism receiving the ultimate toxicant in amounts that cause an adverse effect. The concentration of the ultimate toxicant at the biological target site depends on the absorption, distribution, metabolism and excretion. According to REACH annexe VIII, the assessment of these processes, i.e. the toxicokinetics behaviour is required from the relevant available information. There is no obligation to generate new data.
Source: REACH
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)