Registration of substances

For the derivation of EQCs and the registration of substances (prospective risk assessment), worst-case assumptions are usually applied in the lower tiers, and UFs may be applied, whereas more specific data are used in higher tiers... 

Sci., 28, 175 (1988). Chemical Abstracts Service Chemical Registry System. 10. Registration of Substances from pre-1965 Indexes of Chemical Abstracts. 

DU cannot register substances that they use (except if there is an intended release). However, be aware that the registration of substances by their manufacturers and importers will affect them. It is advised to be active in communicating up (and down) the supply chain to avoid unpleasant surprises. Substances which are not registered will no longer be available on the EU market. 

Danish National Labour Inspection (1985) Order No 199 of 26 March 1985 on epoxy resins and isocyanates etc. Danish National Labour Inspection, Copenhagen Danish National Labour Inspection (1990) Order No. 535 of 12 July 1990 on registration of substances and materials considered to be carcinogenic. Danish National Labour Inspection, Copenhagen... 

Responsible for the registration of substances in EINECS—and later on for ELINCS—was (is) the ECB/JRC (the European Chemical Bureau/Joint Research Centre of the European Commission at ISPRA). This agency was commissioned by the EC administration to allocate an EINECS registration number after having collected, evaluated, and arranged in proper order all notified substances. 

Registration of a new chemical substance in the United States and Japan requkes similar comprehensive sets of data, although there are some differences. Obtaining all the data for a full registration can be time-consuming and costiy. In 1989 it cost approximately 150,000 and took about a year to register a new substance in Europe. 

Fig. 1 Reflectance scan of a chromatogram track with 1 pg of each substance per chromatogram zone (excqttion papaverine 5 pg). Chromatogram (A) before and (B) after reagent treatment (registration of B with double sensitivity) 1 = narceine, 2 = morphine, 3 = codeine, 4 = thebaine, 5 = papaverine, 6 = narcotine.

Control of Pollution Act 1974, 519 Control of Pollution (Amendment) Act 1989, 519 Control of Substances Hazardous to Health Regulations 1999, 1, 12, 112, 119, 137, 141 Control of Waste (Registration of Carriers and Seizure of Vehicles) Regulations 1991, 519 Conversion tables, 543 Copper, 30, 274... 

In eadi specific case the choice of an adsorbent, electrophysical parameters and the method of registration of its change as well as the choice of various pre-adsorption treatment techniques of the surface of adsorbent is dictated by the type and nature of analytical problem to be solved. For instance, if particles active from the standpoint of the change in electrophysical parameters of semiconductor adsorbent occur on the surface of the latter due to development of a chemical reaction involving active particles, it is natural to use either semiconductor material catalyzing the reaction in question or if this is not possible specific surface dopes accelerating the reaction. Above substances are used as operational element of the sensor. If such particles occur as a result of adsorption from adjacent volume, one can use semiconductor materials with maximum adsorption sensitivity to the chosen electrophysical parameter with respect to a specific gas as operational element. 

ICH Expert Working Group, Q1A Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1994. 

REACH requirements for substances, mixtures, and articles do not apply to waste itself. Nevertheless manufacturers and importers of substances, downstream users and potentially recipients of articles have a number of duties under REACH related to substances in waste. Waste-related information must be included in the registration dossier for all substances, including those for which no CSR and/or SDS3 is required (<10 tla) or which are not classified as dangerous. [19]. 

This information is to be submitted to the authorized ECHA for the purpose of substance registrations (details see above in clause 3.4). The essential information should be recorded in the factsheet (SDS) of each chemical including exposure scenarios in case they are substantial. This article describes the importance of the waste stage in the drafting of exposure scenarios. The waste phase is to be included in the calculation of exposure. As part of the implementation of REACH, guidance documents were developed with detailed recommendations which describe how this is to be done. Important aspects of this procedure are explained above. 

The ongoing analysis of registration dossiers should be considered and performed with sensitivity to the waste stage. This should also be done for the selection of substances of very high concern (SVHC, candidate list). For this purpose this task should be designated to the ECHA. 

The use of biocides is in Europe controlled and regulated by the EU Biocidal Products Directive [15]. Registration of a biocide is expensive and only a few active biocide substances will in the future be available for the leather industry in the EU. The directive will include a list of active substances that are permitted to use by the leather industry (a so-called positive list). Many eco-labels and RSL does already today include restrictions of the use of some biocides. 

Bachem produces biochemical and pharmaceutical compounds, and offers complementary services on a proprietary technology platform. Although, oriented to the Health Sector, it supports synthetic methods from customers for defined target structures up to the registration of new compounds. Consequently, R D activities are also a strong part of Bachem business that encourages collaborations with technology partners to produce new active substances. 

The deadlines for registration of existing phase-in substances are based on the date the new Regulation comes into force (Table 6). It is anticipated that ca 30,000 substances will be registered, and that around 80% will not proceed to the next evaluation stage. It is important to note that new substances already notified under the current DSD scheme (Section 2.1) are considered as registered under the new REACH system, but further information will be required at the REACH trigger quantities. 

The information included in the registration of the ca 5,000 substances exceeding a production or import volume of 100 tonnes per annum will have to be evaluated . The proposed Regulation foresees that national Competent Authorities will act on behalf of the ECA to do this work. 

The first step is to identify existing substances, or particular uses of substances, that require authorisation, then to decide on deadlines for authorisation and any uses exempted from authorisation. As additional very high concern substances are identified, largely from testing for registration and evaluation, they will be fed into the authorisation system. 

The Regulation as a whole does not apply to radioactive substances, genetically modified organisms, substances in transit and non-isolated chemical intermediates. In addition, certain other categories of substance are exempt from registration (Table 8). 

Table 8. Categories of substance exempt from registration...

Bishop FS. 1986. Written communication (July 2) to Velsicol Chemical Corporation, Chicago, IL, regarding notice of intent to cancel the registration of certain pesticide products Velsicol endrin 1.6 EC. EPA registration No. 876-153. Office of Pesticides and Toxic Substances, U.S. Environmental Protection Agency, Washington, DC. 

Polymorphism is critically important in the design of new drug API [9] and affects a number of areas. The main impact is to the bioavailability and release profile of a drug substance into the body. This is due to differences in solubility and dissolution rate, between the polymorphs. The chemical and physical stability of the formulated drug substance is also dependent on the polymorphic form. Patented registration of all discovered forms and their manufacturing conditions is an important element in protecting a pharmaceutical companies intellectual property. 

Hypothesis (5) Chemical innovation takes place not only in chemicals . The invention of snbstance applications and the sale of advantage instead of substances are also part of it. In addition, even extremely small market shares of products with an explicit environmental or health-related quality can indirectly become driving forces of improvement innovations in the entire market. This means that the real innovation processes in the domain of chemicals cannot be recorded adequately either solely by statistics relating to new substance registrations or solely by the classic instruments of market analysis. 

Innovation in the area of chemicals is frequently reduced to the development of new substances. The registration of new substances and relevant market shares are thus interpreted as indicators of the innovation activity (or abihty to be innovative) in various economic areas". This indieator appears at best to be eapable of indicating essential aspeets of the iimovation history for the area of the active ingredients (pharmaceuticals and pesticides) and industrial special chemicals. In the extensive market of industrial ehemicals, on the other hand, the invention of new applications for old substances, the reformulation of preparations or the invention of new chemicals services should play a more important role. 

The sale of substance advantage, e.g. the sale of x m of cleaned metal surface on the basis of an arbitrary combination of physical processes and the use of various existing substances , would not have any effect at all as a combined, organisational-institutional and substance innovation e.g. in the registration statistics of new substances. 

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