The new rules concerning the chemical policy of the European Union had became reality; on December 13th 2006 the European Parliament approved the new Regulation of Chemicals known as REACH . Some days after the EU Council adopted REACH on 18th December and published it on December 30, 2006 on the Official Journal of the European Union as Regulation EU no. 1907/2006.The guidelines of regulation will be published within few months in 2007. The regulation has been voted in plenary session with 529 positive agreements, 98 negative and 24 abstains, that will permit to REACH to enter into force on 1st June 2007 with the first requirements and all along the 2008 for other requirements.
Companies involved would be all those that import or produce chemicals (phase-in and new substance) over 1 ton per year in the European Union. Important principles will therefore be the importation the manufacturing and/or the placing on the EU market of chemicals, For more dangerous substances (those under authorisation) a plan of substitution should be developed by the companies in order to switch to safer alternatives; this is a key point under the new regulation. The following main points represents the pillars of the new regulation Duty of care: Manufactures, importers and downstream users are responsible of a safe introduction into the market of chemical substances in order to take care of human health and environment. Therefore Competent Authorities are no longer the responsible for the safety of compounds and the application of the risk management measures but companies themselves before registration. Data sharing: The regulation promote a list of dispositions that encourage companies to share available data on substances that have to be registered, and request to inform the consumers on dangerous substances that can be found in final products.
Promotion of alternative methods to animal testing: The regulation promote the use of alternative methods to animal testing. Methods that first shall be validated by the EU Commission. Furthermore in order to avoid duplications of tests on animals, companies involved will have the possibility to declare the availability of a data (especially performed on vertebrate animals) to be shared with other possible registrant data before starting a new test. A SIEF (Substance Information Exchange Forum) of all data coming form registration or from a pre-registration procedure will be exchanged between interested companies. Registration and Chemical Safety Report: Companies must register every chemical substance imported or produced over or equal 1 ton per year, to the ECA (European Chemical Agency) which will be placed in Helsinki. Every substance over 10 tons per year, must be also followed by a Chemical Safety Report, dispositions of which will be listed in one of regulation annex. Pre-registration (phase-in substances) A substance which has a EINECS number; has been manufactured but not placed on the market 15 years before the entry into force of the regulation and/or is considered a no-longer polymer may be pre-registered in order to benefits of a transitional period to enter in the system. The transitional period is divided in three main periods, 3.5, 6 and 11 eleven years to allow the registration of all the phase-in substances
Authorisation: The more dangerous substances (CMR, PBT, vPvB, etc.) are subjected to authorisation by the EU Commission. The European Chemical Agency (ECHA) will produce a list of candidate substances considered dangerous and therefore submitted to authorisation. Authorisations are temporary, since they should be substituted. Their validities will be valuated case by case. Substitution: Producers and importers of authorized substances have to submit to the ECA a report of alternatives in order to substituted the dangerous product. If the report shows the evidence that suitable alternative exists, companies must submit to ECA a substitution plan, and a detailed calendar of actions to undertake. Restrictions: Every substance considered very dangerous will be listed in a specific annex. For those strong production and importation restrictions will be adopted.
Conclusion The new regulation is considered in Europe a sort of revolution in the approach of the safety for chemicals manufactured or introduced in the European market; the most important news is that all actors in the supply chain of a chemical will have some responsibility in the process towards the Competent Authorities, the Agency and/or the its supplier or its downstream user. Non EU companies which imports chemicals to Europe need to understand the mechanisms of the new regulation as they may have some impact on their business. Therefore It’s becoming urgent for all (manufacturers, importers, downstream users and non EU companies) to act proactively to face the new REACH requirements in order to be prepare for the 2008 application. REACH is a regulation directly applied in all member States without any reinforcement in the legislative system of each European country.
Companies needs to create a multidisciplinary team involving different internal functions such as: - Management to allocate human and financial resources; - Regulatory Office to prepare registrations and general paper work; - HSE Heads for the occupational and environmental aspects; - Legal Office in order to manage the consortia and commercial relationships with competitors; - Sales and Marketing office to check the market implications.
It is expected that large companies will not have huge problems to comply with the new regulation but small medium enterprises (SME) will need to re-organize their internal resources and surely to ask for support from external specialized bodies able for:
- Chemical Safety Report preparation; - Data bank searches; - Monitoring of committed safety studies (toxicology, ecotoxicology/environmental fate and physico-chemistry); - Support to set testing programmes on the basis of the manufacturing levels and type of substance (intelligent testing); - Economic evaluation of the testing programme in case of consortia participation; - Exposure scenario and Risk Assessment.
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