Registration, Evaluation, Authorization Chemicals System

The European system for regulating synthetic chemicals, described in Chapter 5, is predominantly risk-based . This means that restrictions on the manufacture or use of chemicals must be justified by reference to evidence that there is a risk of the chemical causing a specified type of harm. REACH (Registration, Evaluation, Authorization and restriction of Chemicals) does not define the term risk , but the directive on risk assessment of new substances defined it as the incidence and severity of the adverse effects likely to occur [...] due to actual or predicted exposure to a substance (Article 2 of Directive 93/67/EEC). In the first part of this chapter I look at how risks from chemicals are assessed. What does chemicals risk assessment in practice aim to achieve Can it provide the reliable evidence needed for agreement by all parties on whether or not a chemical poses a risk My answer to this second question is no there are multiple uncertainties in chemicals risk assessment which lead to protracted debates as to whether a chemical poses a risk or not. 

According to the novel European regulations named REACH System (Registration, Evaluation, Authorization of Chemicals), every chemical substance introduced into the market at the total amount of more than 1 ton per year has to be registered in the European Chemicals Agency (ECHA). Moreover, if the yearly production or import of the substance exceeds 10 tons, a comprehensive Chemical Safety Report (CSR) is required for the registration [1, 2],... 

The most frequently used BFRs are polybrominated diphenylethers (PBDEs), tetrabromobisphenol A (TBBPA), and hexabromocyclododecane (HBCD). The use of FRs has been growing rapidly in recent years. BFRs are the most often used FRs, and their market is still growing. However, the estimated annual use of OPFRs in Western Europe was almost twice that of all BFRs combined. Many FRs have been banned for use because of their potential toxicity, environmental occurrence, and accumulation in human tissue. FRs taken off the market are likely to be replaced by others. Although the REACH (registration, evaluation, authorization and restriction of chemicals) regulatory system has been introduced in Europe to improve protection of human health and the environment, it is still necessary to monitor FRs in environmental samples [84, 88]. 

Chemical identity issues are of central importance to the successful implementation of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), both for the regulated community and for the European Chemical Agency (ECHA) responsible for REACH S implementation. A variety of nomenclature systems exists, some with similar naming convention but also with critically important differences. 

Establish one system for registration, evaluation, authorization, and restrictions of chemicals that will become immediately effective in all member states. 

REACH (Registration, Evaluation, Authorization of Chemical is the consistent continuation of rules to satisfy the EU administration with a perfect system to safeguard absolute security to protect humans and the environment regarding the use of chemicals. The topic of REACH will not be discussed in detail in this chapter because of its complexity and it touches only to a small extent the title of this contribution. 

REACH is the European Commission s regulatory system for chemicals produced and used in industry. REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals and was enacted into law June 1,2007. This relatively new system aims to increase the collective knowledge of industrially important chemicals, protect human health, and promote environmental sustainability. REACH is committed to obtaining these goals while conserving resources and respecting animal... 

Increased production levels require additional toxicology and ecotoxicology data to ensure that prolonged exposure effects are understood.10 Today, the ELINCS system is being progressed under European proposals labeled REACH—Registration, Evaluation and Authorization of Chemicals. 

In the first stage of the process, the independent body selects QSARs that are potentially useful in the context of a specific regulatory system, such as the future Registration, Evaluation and Authorization of Chemicals (REACH) system in the EU (European Commission, 2001). The selection could be based on a review of the scientific literature, or on the assessment of dossiers submitted by the proponents of QSAR models, such as industry, academia, or regulatory bodies. 

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