Authorisation of Chemicals

Substances of very high concern will have to be authorised for use for specific purposes that have been demonstrated either to present a negligible risk or are essential for socio-economic reasons. It is estimated that ca 1,400 substances will be subject to authorisation. 

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. 

Applications for particular uses of very high concern substances will be assessed at EU level, on the basis of the risk assessment submitted by the applicant, that covers all stages of the life-cycle for that use. The risk assessment is to focus on a more detailed estimation of exposure for the use, and generally no new safety 

The majority of very high concern substances will be those classified as category 1 or 2 CMRs. There are already around 850 such CMR substances based on current classifications, and it is likely that there will be another ca 500 identified from future testing. Most endocrine disrupters would require authorisation by being classified as carcinogenic or toxic for reproduction, but there is the option to add other endocrine disruptors on an ad hoc basis. 

---

REACH (2007) Registration, Evaluations and Authorisation of Chemicals, http //ec.europa.eu/... 

However, the cost of simple substitution and shallow innovation can be substantial. The new EU regulations on Registration, Evaluation and Authorisation of Chemicals (REACH) are expected to result in a large number of chemicals that are currently freely available to vanish from the market. Formulated commercial products such as inks, adhesives and paints can contain up to 60 individual chemicals in one formulation. If one of these is withdrawn as a result of REACH, the potential costs of reformulation can be very high. 

Industry is obligated to submit mandatory dossiers to the REACH (Registration, Evaluation and Authorisation of Chemicals) registry, an environmental protection regulation within the framework of the European Union (EU), and are to include a GHS aquatic hazard classification proposal. Both REACH and the GHS have significant implications for environmental protection... 

The core of the new EU scheme to control chemicals is REACH Registration, Evaluation and Authorisation of Chemicals (32, 93). REACH will place a duty on companies that manufacture, import and use chemicals in the EU to assess the risks arising from their use, which will often require safety testing, and manage any risks identified. 

Registration, Evaluation and Authorisation of Chemicals (REACH), European Commission, Brussels, Belgium, May 2003. 

The effect of European REACH legislation, which will cover all chemicals used in the European countries, on the paint industry is discussed and proposals made for a possible solution. REACH is the abbreviation for Registration, Evaluation and Authorisation of Chemicals. A case study involving vehicle refinish paints is described. Recommendations made by the industry for an improved REACH are considered. 

In May 2003 the Directorates General (DGs) Environment and Enterprise jointly published a draft proposal for an EU Regulation to introduce the new REACH (Registration, Evaluation, Authorisation of Chemicals) scheme. This article explains in some detail the main themes of the new REACH system. 

In what is being called the most far-reaching overhaul of European Union environmental policy ever, the European Commission released a draft policy proposal on May 7 that, if enacted, would require virtually all manufacturers of chemicals to provide risk assessments and other information regarding products they sell or ship into the EU. Chemicals would also have to be registered with the EC and many downstream users of products that contain chemical entities would have to file paperwork as well. The Registration, Evaluation and Authorisation of Chemicals, or REACH, proposal would apply to approximately 30,000 new and existing chemicals, and test data would have to be developed on some 5000 specific chemical entities, many of which have been commonly used for decades. EUROPEAN COMMISSION... 

This presentation discusses current EU chemical legislation and examines the shortcomings of some of the regulations in place with respect to dangerous chemicals. The Commission White Paper is discussed, and in particular, the REACH system which involves the registration, evaluation and authorisation of chemicals used in food-contact applications. The impact of the REACH system on food-contact plastic manufacturers is examined, with respect to suppliers of monomers and additives, plastic manufacturers, converters and packagers. 

REACH. In 2003 the EU Commission proposed a new chemicals policy -REACH (Registration, Evaluation, and Authorisation of Chemicals). The biocides used in AF products are still registered through the BPD, but the other paint constituents as with all other chemical constituents produced or imported > 1 ton/year on the European market will need to be partly or fully risk assessed under REACH. The legislation is expected to enter into force in 2007 (EU, 2003b). 

REACH is an acronym comprising the most important elements of the new chemicals legislation at EU level Registration, Evaluation and Authorisation of CHemicals, cf http //europa.eu.int/comm/enterpiise/chemicals/chempol/whitepaper/reach.htm Cf Grupp et al 2002, Dominguez-Lacasa et al 2003... 

To conclude, research, applications and expectations with regard to emulsions are permanently evolving. Changes in the macro-economic context along with various political decisions (e.g., sustainable development. Registration, Evaluation and Authorisation of Chemicals (REACH) directive for the European Union) are factors which influence the conditions in which emulsion-based products are fabricated and used. It is probable that these changes will motivate technological developments and new advances in emulsion science. 

On 29 October 2003, the Commission adopted a proposal for a new EU regulatory framework for chemicals, the so-called REACH (Registration, Evaluation, and Authorisation of CHemicals). This new regulatory framework achieved all the objectives identified in the White Paper (EU 2001) and thus represents a model of sustainable development by pursuing its three main goals economic (industrial competitiveness), social (health protection and jobs), and environmental. 

The ideas behind the adoption of a new EU chemicals strategy was laid out in a 2001 EC Communication on a Strategy for a Future Chemicals Policy (COM (2001) 88). This document took stock of the system that existed at the time and called for a new strategy based on a system for the Registration, Evaluation and Authorisation of Chemicals - REACH. The Communication set out seven objectives that needed to be balanced within the overall framework of sustainable development ... 

This publication is significant given the fact that the Registration, Evaluation and Authorisation of Chemicals (REACH) proposal entered into force in the European Union in June 2007. Additionally, the regional consultation of the Strategic Agreement on International Chemicals Management (SAICM) in Asia was held in May 2007. 

European Commission White Paper proposes a new regulatory system for chemicals comprising three components registration, evaluation and authorisation of chemicals (REACH)... 

A White Paper published by the European Commission in February 2001 identified inadequacies in the current arrangements and proposed a new system for the registration, evaluation and authorisation of chemicals (REACH). The proposal will change the current procedures for submissions of risk assessments and is discussed later in this chapter. Risk-based decision-making thus has become... 

In February 2001, the European Commission published a White Paper entitled Strategy for a Future Chemicals Policy. The White Paper presented a new regulatory system, called REACH, for the Registration, Evaluation and Authorisation of Chemicals . 

---