EU Chemicals Policy: Regulation, Evaluation and Authorisation of Chemicals - Essay Example

EU CHEMICALS POLICY: REGULATION, EVALUATION AND ISATION OF CHEMICALS 0 INTRODUCTION: Chemicals bring about benefits on which modern society is entirely dependent, for example in food production, medicines, textiles, cars etc. They also make a vital contribution to the economic and social wellbeing of citizens in terms of trade and employment. "The global production of chemicals has increased from 1 million tonnes in 1930 to 400 million tonnes today. We have about 100,000 different substances registered in the EU market of which 10,000 are marketed in volumes of more than 10 tonnes2, and a further 20,000 are marketed at 1-10 tonnes. The world chemical production in 1998 was estimated at 1,244 billion, with 31% for the EU chemical industry, which generated a trade surplus of 41 billion. In 1998, it was the world's largest chemical industry, followed by that of the US with 28% of production value and a trade surplus of 12 billion." (White Paper 2001) This statement underlines the magnitude of the European Chemical Industry. The EU chemical industry is one of the EU's most international, competitive and successful industries embracing a wide field of processing and manufacturing activities. The output of the chemical industry covers a wide range of chemical products and supplies virtually to all sectors of the economy. The EU chemical industry thus creates wealth and generates added value to society. In invests in the future and cares for the people and the environment. On the other hand, there are instances where chemicals were proved harmful to the society, causing endless sufferings and premature deaths and also extensive damages to the environment. Asbestos is one example which can cause lung cancer. Understandably, the public may not really be appreciative of the harm that the different chemicals can do to their lives and well being. Hence it becomes the onus of the government to regulate the manufacture and usage of the chemicals so that there can be an effective control on the harmful chemicals. With this background, this paper attempts to bring out the efforts of the EU on the regulation of manufacture and usage of chemicals, their evaluation and authorization for use. This paper derives the inputs from the legislative proposal of the EU commission REACH- Registration, Evaluation and Authorisation of Chemicals. 2.0 REASONS FOR REGULATING CHEMICALS: Protection of human health and the environment is the primary concern of the government. It must be ensured that not only the present generation of the people but also the future generation is living without fear of the chemicals endangering their health. Similarly the efficient functioning of the internal market and the competitiveness of the chemical industry is another responsibility of the government. The governmental policy should regulate the manufacture of the chemicals and at the same time, provide for the incentives for technical innovation and development of those chemicals which are considered safe. In order the chemical industry becomes sustainable, a balanced growth providing for the consideration of ecological, economic and social aspects in the manufacture of chemicals is very much necessary. The EU Commission with the twin objectives of protecting the human health and regulating the development of the chemical industry has embarked upon the system of registration, evaluation and authorization of the different chemicals. 3.0 CHMICALS POLICY OF THE EU: In order to bring more effectiveness on the control of the chemicals the EU commission reviewed the existing legislative directives which were governing the industrial chemicals, metals, minerals and substances produced from natural products to analyse the applicability of such provisions in the present day environment. Apart from improving on existing measures, the EU also proposed to bring out additional legislative measures controlling the manufacture and use of plant protection products, cosmetics and the transport of dangerous goods among other things. "The existing regulatory system inherent in current EU policy dealing with the majority of chemicals - known as existing substances - has been in place since 1993 and has prioritized 140 chemicals of high concern." - (Defra 2002) Since the progress on regulatory action was slow, the EC in the year 2001 brought out a white paper which contained ideas about the future chemicals policy of the EU. The white paper prescribed a single system facilitating the gathering of hazard information, assessing the associated risks, classifying, labeling and restricting the marketing and use of individual chemicals and mixtures. This is known as REACH system comprising: Registration of basic information of substance to be submitted by companies, in a central database. Evaluation of the registered information to determine hazards and risks Authorisation requirements imposed on the use of high concern substances; This process will be used for both new and old CHemicals. 'The policy aims to cover both "new" and "existing" substances. All chemicals produced or imported into the EU in quantities above 1 tonne per year would be registered in a central database. Chemicals deemed to be of most concern would need an authorisation. This would require industry to gain specific permission for particular uses which have been demonstrated to be safe. Other uses would be prohibited."- (Defra 2002) It was also proposed that a new European Chemicals Agency will be created and necessary amendments to the existing regulations will be carried out. 4.0 OBJECTIVES BEHIND IMPLEMENTATION OF 'REACH': The Current legislations suffer from some major problems in the area of assessing the hazards connected with the chemicals and controlling them to protect the environment as well as human health. The problems that were identified are: Lack of data on intrinsic properties of existing chemical substances Lack of knowledge about how chemicals are used by the downstream users Enterprises due to lack of knowledge on properties and uses of chemicals are unable to classify and label the chemicals correctly to implement appropriate risk management procedures. Inability of the EU member states to conduct hazard and risk assessment of substances in the absence of sufficient information and resources resulting in only a few sentences being assessed. The major objective of REACH is to shift the responsibility for ensuring and demonstrating the safe manufacture, use and disposal of chemicals which is currently with the 'authorities' to the 'industry'. 5.0 SALIENT FEATURES OF 'REACH': On 30th December 2006, the Official Journal of the EC published 'REACH' the regulation No 1907/2006 amending the current directive 67/548/EEC of the Council. Under 'REACH' enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register in a central database. Apart from protecting the environment and the human health from hazardous chemicals, "REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production." (Paper on Reach 2007) Before making REACH as a regulation the proposal was drafted in consultation with all interested parties and this enabled the Commission to propose a streamlined and cost-effective system. The Council adopted the final version of REACH text at the Environment Council on the 18th December 2006 and 'REACH' will be made effective from 1st June 2007. REACH essentially comprises of the following four procedures: Registration of chemicals, documenting that risks are adequately collected Evaluation of the registration dossiers considering mainly testing proposals Autthorisation of substances of very high concern Restriction of substances at the level of European community when industry measures are not sufficient. The following is a brief description on the above procedures. 5.1 REGISTRATION UNDER 'REACH': As aforesaid, manufacturers and importers of chemicals in excess of one tonne per annum, need to get the substance registered. "The general assumption behind tonnage triggers is that, on average, the higher the tonnage the higher the potential exposure(s) and, in turn, the higher the potential risk(s)." (Frans M.Christensen et al 2003) While the tonnage trigger system is a simple and transparent methodology which can be implemented easily, the actual risk from a hazardous substance will be determined only after the use and the resulting exposure which is a limitation of REACH. The registration procedure will consist of a technical dossier containing information like: The identity of the manufacturer or importer The substance identity Information on the manufacture and intended uses of the substance The proposed classification and labeling of the substance Guidance on safe use of the substance A testing proposal should any further testing is required. For substances where the tonnage is more than 10 per annum, the technical dossier will also call for a Corporate Social Responsibility Report that demonstrates the safe use of the substance throughout the supply chain. 5.2 EVALUATION UNDER 'REACH': There will be an evaluation of all testing proposals for all substances which are manufactured or imported in quantities above 100 tonnes per annum. Such evaluation will be conducted by the EU Member State Authorities. The evaluation will also be conducted on any other substance if under priority and such evaluation is considered necessary. "Substance evaluation allows for further checks in situations where a member state has identified certain properties or uses of a given substance that give rise to concern. Such evaluations may lead to a request for additional data or assessment. In some situations, evaluation will lead to action under the authorisation or restriction procedures." (Frans M.Christensen et al 2003). The main objective of the evaluation procedure is to limit the animal testing by deciding on the necessity of the testing proposals submitted. 5.3 AUTHORISATION UNDER 'REACH': An authorisation procedure will be applied to substances of very high concern. These include substances classified as carcinogenic, mutagenic or toxic to reproduction in categories 1 and 2 (CMR substances), substances with a potential for persistence and bioaccumulation combined with high (eco-)toxicity (PBT substances; see Table 1) or very persistent and very bioaccumulative substances. Case by case authorization will be granted for substances giving rise to a similar level of concern (e.g. substances with endocrinedisrupting properties). "Substances included in the authorisation are generally considered to be undesirable because of their inherent and potent capability of causing harm. The rationale for regulating these substances based on inherent properties is that it is difficult to assess, predict and control the long-term consequences of emission (and the subsequent effects of exposure) of these substances". (Frans M.Christensen et al 2003) When a safe use of the substance can be demonstrated authorization can be granted to one or more specific uses of a substance. Similarly in cases where safe use of the substance cannot be demonstrated an authorization can be granted on the basis of a conclusion that the societal benefits of the substance outweighs the risks which is proved by means of a socio-economic analysis. 5.4 RESTRICTIONS: It it is considered that some risks could not be or are not managed adequately by other parts of REACH as in the case of situations where the aggregated tonnage of the multiple registrations create concerns which were not anticipated in the individual safety assessments or when it is necessary to accelerate the risk reduction of the specific uses of specific substances, Restriction proposals may be submitted in the form dossiers. 6.0 CONCLUSION: Thus the new EU chemicals policy will enhance the responsibility of the industry especially to ensure and record the safe manufacture, use and disposal of chemicals. By applying the existing methodologies as well as by applying new techniques and tools the envisaged assessments will be carried out. The most notable feature of REACH is the basic idea of exposure scenarios which allow for the technical descriptions and the conditions under which a chemical can be manufactured and used safely. However with the ever-growing innovation processes there are bound to be new chemical substances that will get added everyday. Hence it is for the EU and the industry to look for measures beyond REACH to ensure the protection of human health and the environment in which we live. Reference List: 1. Defra 2002 Paper on Future EU Chemicals Policy Environmental Protection [Online] Available from: http://www.defra.gov.uk/environment/chemicals/reach/index.htm Accessed on 30th January 2007 2. Frans M.Christensen et al 2003 Assessment Tools Under the New European Chemicals Policy Greenleaf Publishing [Online] Available from: http://ihcp.jrc.ec.europa.eu/docs/ecb/Assessment_tools_REACH.pdf Accessed on 30th January 2007 3. Paper on Reach 2007 The New EU Chemicals Legislation - REACH Enterprise and Industry [Online] Available from: http://ec.europa.eu/enterprise/reach/index_en.htm Accessed on 30th January 2007 4. White Paper 2001 Strategy for A Future Chemicals Policy Commission of the European Communities [Online] Available from: http://europa.eu.int/eur-lex/en/com/wpr/2001/com2001_0088en01.pdf Accessed on 30th January 2007 Read More