Chemical Policy Regulation Essay

The European Commission’s Registration, Evaluation and Authorisation of Chemicals (REACH) is a new system wherein manufacturers, distributors, and importers are required to sign-in their chemical inventories into a centralized database, along with information on physical and chemical properties, safe handling, hazards, and uses. Substances with carcinogenic, toxic, or mutagenic activity will require permission before being used, and any chemical whose risks are too unmanageable will be banned for use. REACH will thus be an aid in the management of information on chemicals, since it will demand that unknown data on chemicals currently in use be determined for registration purposes, and that new chemicals to be used by industry will now have a standardized procedure for the acquisition and distribution of information and control on their use. In detail, REACH will operate in the manner described in the following sentences. First, parties dealing in chemical products will be required to send a dossier of information on chemicals that they handle that are produced in excess of 1 metric tonne annually. Basic information will be required of chemicals dispensed in the range of 1-10 metric tonnes, while more will be asked of chemicals distributed in larger quantities. As an example of additional data that will be required, substances produced in excess of 10 tonnes annually should have an associated chemical safety report in which the hazard and risk assessment of the substance for specified uses must be outlined and how the risks posed by the chemical can be ‘adequately controlled’ for these uses. One component of the assessment is an â€Å"exposure scenario†, a summary of the use(s) and appropriate risk management measures for the substance studied. All the safety data then submitted for â€Å"substances of very high concern† and chemicals used in bulk will be evaluated by a panel of experts, and any chemical whose use cannot be justified in terms of its risk of use being under control or its socio-economic value outweighing risks considered will be subjected to a phase-out and replacement with safer alternatives, if there are any. REACH in effect is an implementation of the venerable â€Å"precautionary principle†, one statement of which being that the burden of proof of a chemical’s ability to deal severe or irreversible harm should be foisted upon the advocates of the chemical’s use, in the absence of evidence that the chemical is safe for use. To illustrate the importance of the â€Å"precautionary principle†, one only needs to look at dichlorodiphenyltrichloroethane (DDT) and the organochlorine pesticides that followed. At the time of their introduction, they were widely accepted and hailed as being much safer than the inorganic pesticides such as the arsenicals that were then the mainstays of pest control. It was only after many years of use that their deleterious effects towards human health and the environment became noticeable. In short, the tenet â€Å"innocent until proven guilty† is not to be applied to chemicals that may require years of use before exerting ill effects, and by then the damage done may already be too difficult or impossible to undo. REACH aims to address issues such as safety, the phasing out of â€Å"substances of concern†, and the encouragement of innovation in industry. In detail, REACH can address health issues because, by its very nature, it will prevent the unnecessary use and needless release into the environment of substances whose risk of use cannot be justified as against the benefits that can be accrued. In this respect, if it can be shown that a substance under scrutiny has no justifiable reason for its continuous use because of the availability of environmentally benign alternatives, its phase out will be implemented as soon as possible. Finally, industry will be spurred, in theory, to research possible replacements for the hazardous chemicals that they currently use due to the pressure exerted by REACH to limit or stop the use of   hazardous chemicals, paving the way for innovations. To facilitate the implementation of REACH, the European Chemicals Agency will be established in Helsinki, Finland. The Agency will serve to coordinate the majority of the work related to chemical regulation and evaluation. Members of the European Union still wield responsibility, however. A large portion of the data gathered through REACH will be publicly accessible. The legislation aims to protect human health and the environment, but the risk of negatively impacting the European economy has been brought up by concerned parties. Efforts to strike a happy medium have been going on for several years. One side has talked about increases in the incidence of cancer and disorders related to the malfunction of the endocrines, while the other side has focused on burgeoning red tape, rises in costs and loss of jobs as businesses move away from Europe. Groups with vested interests in the chemical industry have been accused of lobbying to water down REACH for their benefit. As such, there are groups that say that REACH has loopholes that can enable unscrupulous industries to persist in using â€Å"substances of very high concern† for their convenience. While industry has sought to have REACH’s requirements loosened, European trade unions and environmentalists have joined forces in arguing for strong legislation. It is said that one in three work-related illnesses in the 15 older EU member states is due to chemical exposure. REACH also enjoys the backing of consumer groups and medical associations. A limitation of REACH is that it only applies to chemicals manufactured in or imported into the EU, and therefore is not applicable to chemicals that are incorporated into finished products. So a product like a television, or computer or shampoo made outside the EU could contain chemicals that are not registered under REACH – providing they are not banned under specific safety regulations (such as lead). Polymers (plastics, rubbers, and ilk) are excluded from the auspices of REACH for the time being, but monomers, or the chemicals used to make them, will still be covered by REACH. Pesticides, biocides and   human and veterinary pharmaceuticals are also exempt from REACH, the rationalization being that they are regulated under a different legislation from industrial chemicals. Industrial byproducts and waste are also not covered by REACH, but substances produced from waste or substances used in the processing of waste are covered by REACH. REACH defines what it calls â€Å"substances of very high concern† as substances that belong in any of these categories: substances that are cancer-causing (carcinogenic), mutation-inducing (mutagenic) or interfere with the body’s reproductive function (CMRs); substances that take a long time to break down (persistent), accumulate in the body (bioaccumulative) and are toxic (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances that have serious and irreversible effects on humans and the environment, for instance endocrine disrupting substances. Any new results in light of the effects of a chemical under scrutiny on the environment or human health can influence its retention or phasing out.   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   As an example of the chemicals that can fall under these previously mentioned classes, the previously mentioned organochlorine pesticides will fall under the PBT category; Alar, a plant growth regulator that was pulled out from the market due to concerns about the mutagenicity and carcinogenicity of one of its breakdown products will fall under CMR, and the chlorofluorocarbons (CFCs) which, although nontoxic, tend to persist in the atmosphere to cause damage to the ozone layer will belong to the vPvB category. Note that a chemical only has to satisfy one of the set criteria of a certain category to belong.   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Hazard triggers are an approach where â€Å"substances of high concern† are classified according to the hazards they present when tested in various models. Hazard triggers can be used as an adjunct or substitute for risk assessment since it is usually faster and cheaper to use such. However, extrapolating results of lab tests to what can happen when a chemical is used outside the lab is not always accurate. It has happened in previous times that there were chemicals that exhibited no injurious effects in lab tests and were subsequently shown to be unsafe when used in the field. Conversely, there have also been cases where a chemical that was initially shown to cause serious health problems in animal models was barred from further use even if subsequent tests demonstrated that its use poses no risk to human health. As such, the evaluation of a chemical’s safety based on hazard triggers should proceed on a case-to-case basis, and should be thoroughly scrutinized. Example hazard triggers include persistence (measured in terms of half life in soil or aquatic medium), long-range transport (quantified by the DT50), and ecotoxicity (of which the LC50 is the quantifying parameter). – aims of REACH – controversial issues associated with the legislation – substances of `high concern` – hazard triggers and risk assessment – the implications of REACH for Environmental protection References BBC News (2005) Q&A: REACH Chemicals Legislation [online] accessed at http://news.bbc.co.uk/1/hi/world/europe/4437304.stm Department for Environment, Food and Rural Affairs (2004) Government Response to the Royal Commission on Environmental pollution Report on Chemicals in Products, Cm6300, HMSO [online] accessed at http://www.defra.gov.uk/environment/chemicals/ukpolicy.htm European Commission (2006) REACH in Brief, based on common position of the Council [online] accessed at http://ec.europa.eu/enterprise/reach/index_en.htm The Lowell Center for Sustainable Production (nd) REACH – The New EU Chemicals Strategy: A New Approach to Chemicals Management [online] accessed at http://www.chemicalspolicy.org/reach.shtml REACH Compliance (2007) http://www.reach-compliance.eu/english/index.html