Lexikon
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 When the current provisions are repealed and GHS enters into force, the R-phrases will be replaced by "hazard statements".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
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 Glossary)
Random Access Memory
Random Access Memory
RCR = Risk Characterisation Ratio, the ratio of Predicted Environmental Concentration (PEC) and Predicted No Effects Concentration (PNEC) (PEC/PNEC). See also Risk Quotient (RQ).
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
recombinant DNA technology means the procedure used to join together DNA segments in a cell-free system (an environment outside a cell or organism). Under appropriate conditions, a recombinant DNA molecule can enter a cell and replicate there, either autonomously or after it has become integrated into a cellular chromosome.
Recombinant DNA technology is also called genetic engineering or in vitro DNA recombination.
minimizing waste generation from site remediation by recovering and reprocessing usable products that might otherwise become waste (Source: EUGRIS).
the average composition of red mud is the following:
| Fe2O3 | 30−60% |
| Al2O3 | 10−20% |
| SiO2 | 3−50% |
| Na2O | 2−10% |
| CaO | 2−8% |
| TiO2 | 0−25% |
reference dose is the maximum acceptable oral or dermal dose of a toxic substance. The EPA defines an oral reference dose (abbreviated RfD) as an estimate, with uncertainty spanning perhaps an order of magnitude, of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. http://www.epa.gov/economics/children/basic_info/glossary.htm
Reference doses are chemical specific, i.e. the EPA determines a unique reference dose for every substance it evaluates. Often separate acute and chronic RfDs are determined for the same substance. Reference doses are specific to dietary exposure. When assessing inhalation exposure, EPA uses "Reference concentrations," (RfCs), instead of RfDs. Note that RfDs apply only to non-cancer effects. When evaluating carcinogenic effects, special risk assessment methodology is applied.
RfDs are usually derived from animal studies. Animals (typically rats) are dosed with varying amounts of the substance in question, and the largest dose at which no effects are observed is identified. This dose level is called the "No Observable effect Level," or NOEL. To account for the fact that humans may be more or less sensitive than the test animal, a 10-fold uncertainty factor is usually applied to the NOEL. This uncertainty factor is called the "interspecies uncertainty factor" or Ufinter. An additional 10-fold uncertainty factor, the "intraspecies uncertainty factor" or Ufintra, is usually applied to account for the fact that some humans may be substantually more sensitive to the effects of substances than others. Additional uncertainty factors may also be applied. In general:
Frequently, a NOAEL is used in place of a NOEL. If adverse effects are observed at all dose levels tested, then the smallest dose tested, the "Lowest Observed adverse effect Level" or LOAEL, is used to calculate the RfD. An additional uncertainty factor usually applied in these cases, since the NOAEL, by definition, would be lower than the LOAEL had it been observed.
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)
REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF
gene (a functional part of DNA) is transcripted into RNA (ribonucleic acid) and RNA translated into proteins in every living cells.
Some proteins are constitutively expressed (present all of the time), but cells can regulate the expression of proteins that are not needed all of the time or in large amounts. This provides cells with control mechanisms for turning metabolic reactions on and off. Cells use a variety of mechanisms to regulate gene expression, and thus which proteins are produced.
Proteins can be controlled or regulated at the level of their synthesis (regulation of gene transcription), gene translation, various post-translation mechanisms and feedback inhibition, or the recently discovered actions of RNAi and microRNA.
regulatory toxicology gathers and evaluates existing toxicological information, develops uniform, standardized, comparable methods for testing and evaluating not only the effects but also the fate and behavior of chemical substances both in the environment and in the organisms. Regulatory toxicology means the interpretation and use of toxicity-results for the establishment of effect based quality criteria for food, drinking water, other water uses (e.g. irrigation), animal feed, all environmental compartments, such as air, surface waters, sediments, subsurface waters, soils, depending their use and users (land use) as well as for waste utilization (e.g. sewage sludge utilization on soil). Regulatory toxicology tries to control hazardous substances and materials in a safe matter, ensuring an acceptable risk level, or with other words, a safe exposure.
Regulatory toxicology is the study of the adverse effects of chemicals, not just on humans, but also on all living organisms including plants, animals, fungi and insects. The integration of metabolism, toxicity, pathology and mechanism is playing a much greater role today than ever before. A better understanding of these areas is essential for proper regulation of chemical substances and drugs and every other material, product or waste which contains hazardous chemical substances. It can also play an important role in the development of backup drugs and chemicals. We have to emphasize, that the origin of chemical risk is not only the hazard of a substance, but also the abnormal concentration or presence of a chemical substances at a not proper place and time.
environmental toxicology should serve regulation, scientists should know the concepts of regulation and the way how to fill the gaps with methodologies and information, moreover to advise on the need for their integration into the regulatory decision making.
The importance of regulatory toxicology is highly certified by the regulations on pesticides, biocides, food additives, cosmetics and the regulation of hazardous chemical substances and materials all over the world.
each gene is a linear stretch of DNA nucleotides that codes for the assembly of amino acids into a polypeptide chain (protein). DNA is transcribed into RNA (transcription), and RNA carries the message for making the protein to another part of the cell where it is translated into the amino acid chains that will make up the protein (translation).
for the in situ or ex situ remediation of hydrocarbons, pesticides, chlorinated substances contaminated soils the altering oxic-anoxic or aerobic-anaerobic treatment is an efficient bioremediation alternative. The steps of the technology application are:
1. Addition of organic soil amendment, zero valent iron, and water to produce anoxic conditions.
2. Periodic tilling of the soil to promote oxic conditions.
3. Repetition of the anoxic-oxic cycle until the desired cleanup goals are achieved.
The addition of DARAMEND® organic amendment, zero valent iron, and water stimulates the biological depletion of oxygen, generating strong reducing anoxic conditions within the soil matrix. The diffusion of replacement oxygen into the soil matrix is prevented by near saturation of the soil pores with water. The depletion of oxygen creates a low redox potential, which promotes dechlorination of organochlorine compounds. A cover may be used to control the moisture content, increase the temperature of the soil matrix and eliminate runon/run off.
The soil matrix consisting of contaminated soil and the amendments is left undisturbed for the duration of the anoxic phase of treatment cycle typically 1-2 weeks. In the oxic phase of each cycle, periodic tilling of the soil increases diffusion of oxygen to microsites and distribution of irrigation water in the soil. The dechlorination products formed during the anoxic degradation process are subsequently removed trough aerobic oxic biodegradation processes, initiated by the passive air drying and tilling of the soil to promote aerobic conditions.