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The aim of the strategy is to ensure protection for human health and environment. The new policy on chemicals would place the burden of proof on industry to provide information on the hazards of the chemicals they make use or sell. The proposal basically says- "No data No market", the countries that constitute the EU would be responsible for assessing this information on a case- by case basis. Chemicals that are hazardous in nature would be considered of high concern. According to REACH, it is not only the EU industry (importing or using chemicals) which needs to provide product information in detail but also the manufacturers outside European countries, who are selling the chemicals to these companies will also have to meet the above. REACH will place a duty on companies, which produce, import and use chemicals to assess the risks arising from their use requiring new test data to be generated in justified cases - and to take the necessary measures to manage any risks they identify. This will reverse the burden of proof from public authorities to industry for putting safe chemicals on the market. Testing results have to be shared to reduce any likely animal testing. Registration of information on the properties, uses and safe use of chemical substances will be an integral part of the new system. |
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The New EU Chemical Policy should put Europe well in advance of most of the other countries interms of health and safety guarantees provided by manufacturers and importers of chemicals.
The prime responsibility for following the Chemicals Policy rests with Cefic, Euro Chlor is providing expert inputs by chairing two of the working groups that are dealing with Risk Assessment and definitions of persistent, bioaccumulative and toxic chemicals (PBTs).
Whilst supporting the overall aims of the review, Euro Chlor believes that the new process should not incorporate unnecessary general principles. For example, substitution of hazardous chemicals by less hazardous alternatives should not be viewed as a goal, but as one tool to reduce risk. One specific aspect of concern to Euro Chlor is the proposal that REACH should apply to all substances, even intermediates. For substances of very high concern, the authorities will have to authorise their use for a specific purpose and Euro Chlor believes that such authorisation should be restricted to POPs characterised in the Stockholm Convention and to substances that are carcinogenic, mutagenic and nephrotoxic. |
The main features of REACH
Registration |
the main element of REACH. Manufacturers and importers will demonstrate in a registration dossier that they are managing their chemical substances safely. Companies will be required to register all substances produced or imported in volumes of 1 tonne and more per year per manufacturer or importer in a central database run by an independent agency to be created. Information requirements will largely depend on volume, but may be tailored based on intrinsic properties and conditions of use. |
Registration will involve providing information on, among other things: |
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The intrinsic properties and hazards of each substance (such as physico-chemical, toxicological and eco toxicological properties). Animal testing is to be kept to a minimum and costs reduced by sharing existing data. |
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The use(s) for which the substance is intended and information on whether/ how it may come into contact with people and/or the environment (known as the exposure scenario) |
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An assessment of risks for human health and the environment |
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A statement on how the producers or users are managing the risks associated with the use(s) of the substance. |
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| For low volume chemicals (less than 100 tonnes/year) that do not raise concerns, registration alone will be sufficient. It is expected that around 80% of all substances will only have to be registered. All substances produced in higher volumes will be subject to evaluation. Evaluation will also be used for substances of concern, e.g. if there are indications that they may cause serious chronic effects. To cope with the large number of the existing substances a phased approach is proposed with deadlines for registration set according to the volume of the substance on the market or hazard. |
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| Evaluation |
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the registration data will be examined by the Competent Authorities of the Member States. Standard evaluation is compulsory for substances on the market above 100 tonnes and mainly aims at reducing animal testing.
Member states also have the opportunity to evaluate any substance (make a priority evaluation) and may ask for additional information or testing if they have any concerns about the potential risks posed by the substances or the quality of the registration dossier. |
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| Authorisation |
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the most hazardous substances will be controlled by requiring an authorisation for their use. This authorisation will permit specific uses under certain conditions. Companies applying for an authorisation will have to demonstrate that they can adequately control the risks posed by the chemical substance or that the social and economic benefits of the substance outweigh the risks. The possibility for substitution will also be considered.
Examples of substances that will be subject to authorisation are those expressing certain characteristics: CMRs (carcinogenic, mutagenic or toxic to reproduction), PBTs (persistent, bio-accumulative and toxic) and vPvBs (very persistent, very bio-accumulative). Endocrine disrupting substances and other substances that give rise to similar levels of concern will be subject to authorisation on a case-by-case basis. Restrictions are the safety net of the system. It will give the possibility to introduce restrictions at EU level on any substance that poses unacceptable risks, taking due account of socio-economic factors. |
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| Scope of REACH |
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The exact registration requirements will vary depending on the volume in which a substance is produced, and on the likelihood of exposure to humans or the environment. A phased-in system lasting up to 11 years is foreseen. Higher tonnage substances would require the most data, and would have to be registered first; lower tonnage substances would require less data and be registered later. The latter provisions will particularly reduce the regulatory burden on small and medium sized enterprises.
Tighter controls will be introduced for the chemicals of highest concern. Thus, certain types of substances such as carcinogens, mutagens and reproductive toxicants (CMRs), persistent, bioaccumulative and toxic substances (PBTs) and very persistent and very bioaccumulative substances (vPvBs) will be subjected to an authorisation regime and would be registered early. In certain cases also other substances, for example with endocrine disruption effects, could be included on a case by case basis within the authorisation system where it is shown that they give rise to the same level of concern. Each use of such substances will have to be authorised for a specific use. Decisions would be based on a risk assessment and consideration of other socio-economic factors. Others, such as the polymers (chemicals used as raw materials for plastics and detergents and a wide variety of other products), and substances used as intermediates (chemicals used to make other chemical substances or other products) will be subject to substantially lighter registration requirements. In many cases, where there is little risk of exposure, polymers and intermediates will be exempted from registration.
It is expected that around 80% of all substances will only have to be registered; the rest will have to undergo evaluations for safety and subsequent authorisation. The Member States will be responsible for the evaluation of substances by examining certain registration dossiers, as well as checking the application of REACH within their own territories. They will also be able to suggest restrictions on the use of substances based on a structured risk assessment - where they consider that EU legislative action is necessary, although the final decision on such restrictions would be taken by the European Commission. |
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| The Commission would grant authorisations after taking into account the views of the Agency on the risk and on the socio-economic aspects. Authorisation decisions will take into account the guarantees provided by the applicant firms and available information on alternative substances and processes that may reduce the risk posed. To simplify the system and to reduce costs, an authorisation will be valid for enterprises further down the supply chain as long as they abide by the conditions of the authorisation for the intended use and inform the Agency. |
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| Effect of REACH on industry |
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| Costs |
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| Testing and registration costs : The Commission's Impact Assessment estimates the direct costs of REACH to the chemicals industry at a total of some €2.3 billion over an 11-year period, including fees to the Agency of €0.3 billion. |
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| Costs to downstream users : The costs to downstream users of chemicals are estimated at €2.8 - 3.6 billion if the market behaves as expected with 1 - 2 per cent of substances withdrawn because continued production would not be profitable. Costs could rise to €4.0 - 5.2 billion if industry faces higher supply chain adaptation costs. These estimates include the direct costs passed on from the chemicals sector to downstream users. |
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| Total costs : The overall costs to the chemicals industry and its downstream users would then be €2.8 - 5.2 billion. From a macroeconomic perspective, the overall impact in terms of the reduction in the EU's Gross Domestic Product (GDP) is expected to be very limited. |
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| Impact on SMEs |
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Small and medium sized enterprises (SME) are an important part of the EU chemicals industry. Since safety is a key concern, regardless of company size, the REACH information requirements relate to production volumes, uses and properties of the chemicals, and not to turnover or the number of employees of the companies.
Many of the SMEs that will be affected by the present legislative proposal are 'downstream users', that is companies that buy chemicals and use them as ingredients in their own products or use chemicals in an industrial or professional way.
As a result of their position in the value added chain, most chemicals will already be registered when they are utilised by downstream users. Most of the ways in which the chemicals will be used will be covered by the safety assessments carried out by the registrants. This will help to ensure a high level of chemical safety for downstream users. |
SMEs that are manufacturers will be able to take advantage of the incentives for innovation that the REACH system will create, such as: |
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Exemptions from testing requirements for substances used in scientific or product- and process- orientated research and development. |
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Light information requirements for low volume substances that do not fall under authorization (registration threshold at 1 tonne/year per manufacturer/importer, normally only in vitro testing for substances between 1 and 10 tonnes). This should reduce the costs for manufacturing SMEs, who will typically work in this range. |
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Administrative burdens and costs can partly be shared between registrants in the pre-registration process. |
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| Loss of substances |
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Downstream users fear that some substances would not be registered because manufacturers will not consider it worthwhile to pay the cost of registration.
Due to the dynamic nature of the market for chemicals, it is difficult that essential chemicals will disappear without being substituted. The REACH system will act as a spur to innovation, by encouraging companies to develop substitute products for some of those substances which otherwise might need to go through the authorisation process. |
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| Pros & Cons of REACH |
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The fundamental question on the REACH policy is questionable cost effectiveness and unnecessary increase of costs for chemical producers, users, and the general public;
The effect that such a unilateral EU initiative could have on existing global harmonization and cooperation efforts on chemicals and the market access barriers for developing countries seeking to export chemicals or manufactured goods to the EU are some of the concerns raised.
The benefits of the REACH system are twofold: risks to human health will be reduced and environmental quality will be improved through the better and earlier identification of the properties of chemical substances and through the new framework for registration, assessment, and authorisation of chemical substances. These impacts are difficult to estimate in monetary terms and are being subjected to further study. Further significant benefits are expected as a result of improvements in general health, in addition to benefits for the environment.
The European chemicals industry will benefit from a single EU regulatory system, decision making with set deadlines and a high quality image for their products.
Downstream users of chemicals will get relevant information on the safe use of each chemical substance they buy. They will have closer contacts with their suppliers, and will be able to ensure better protection of their workers. Their products will be safer for consumers and the environment. Based upon the results of an independent study conducted to evaluate the impact of REACH in the occupational health area, the likely occupational health benefits are estimated at between €18 and €54 billion over a 30-year period. |
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| Implications of the New Chemical Policy on Indian Industry |
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The foremost and the important positive impact would be on Indian companies that are able to offer safer substitutes for hazardous materials. They would be able to better manage the access to the European market and benefit from the same.
The scope for profitable products is certainly on the higher side whereas the non-profitable products might get withdrawn from the market due to the high costs of testing of the chemicals. This cost of testing is a concerning factor for the small and medium scale industries which might not be able to withstand the registration costs. There would definitely be an extra cost burden on the suppliers and this might indirectly help in reduction in outsourcing from the European countries. This might result in loss of business for the Indian companies. However if companies take it as an opportunity and make an investment towards cost of registration, EU holds good market potential.
REACH would prove to be more focussed and efficient if it first looks into the existing information on risk, use and exposure information. This would, at a stroke, cut a huge amount of testing, reduce the number of animals needed and allow the authorities to prioritise testing so that high-risk chemicals can be registered and evaluated and - where necessary - alternatives products can be found. Most importantly, it should be achievable - not only in terms of time scale and resources available - but also in terms of the ability of the industry that is threatened to react and cope with the requirements. |
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| Sources: |
| www.europa.eu.int/comm/enterprise/chemicals |
| www.iccwbo.org |
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| For further information, Contact: |
| Mail: envis@ciionline.org |
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