Lexikon

CPU, Central Processing Unit in computers

transgenic animals may be developed for a wide range of purposes. Some of the areas in which transgenic animals are important are: medical research, livestock improvement, pharming and xenotransplantation.

Pharming means the production of biologically active human proteins, diagnostics, monoclonal antobodies, and nutraceuticals.

a protected species is any plant or animal a government declares by law to warrant protection. Most protected species are considered either threatened or endangered. In these cases, a government establishes certain rules regarding the species, that if violated, can result in fines or criminal prosecution.

The impetus behind protected species laws is risk of species extinction. Ecologists have demonstrated that losing even the smallest of species can have a direct effect on the rest of the plant and animal population. For example, a grass eaten by a specific animal becomes extinct due to habitat destruction. The animal may die off as a result of not finding its food source available, causing further disruptions in the food chain.

Source: http://www.wisegeek.com/what-is-a-protected-species.htm

proteomics is the study of protein molecules in the cell to find association with the composition and cellular response to toxic chemical substances. It is an innovative tool in pharmacology, toxicology and environmental toxicology.

Proteins are the primary structural and functional molecules in the cell, and are made up of a linear arrangement of amino acids. The linear polypeptide chains are folded into secondary and tertiary structures to form the functional protein. Unlike the static nature of the cell's genes, proteins are constantly changing to meet the needs of the cell.

Characterizing the identity, function, regulation, and interaction of all of the cellular proteins of an organism, the proteome, will be a major achievement. Studies of changes in the proteome of cells and tissues exposed to toxic materials, compared to normal cells, is being used to develop an understanding of the mechanisms of toxicity. As proteomics tools become more powerful and widely used, protein and proteome changes in response to exposures to toxic substances (fingerprints or response profiles) will be developed into databases that can be used to classify exposure responses at various levels of organization of the organism, thus providing a predictive in silico toxicology tool.

see pyroclastics

see pyroclastics

see pyroclastics

see volcanic pyroclastic rocks

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)

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 1^st 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

Annex XVII of REACH lists all restricted substances and the conditions of their restrictions under REACH.

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