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Reach Regulations

Reach Regulations

EC REACH Regulation 1907/2006, published on 30/12/2006, is a thorough revision of all EU regulations dealing with the protection of health and the environment in the chemical substances control sector, and for the first time it makes industries responsible for demonstrating the safety of their own products.
The REACH Regulation (acronym for Registration, Evaluation, Authorisation of Chemicals) came into force on 1 January 2007 and calls for the registration of all substances produced or imported into the European Union area in quantities equal to or exceeding one ton per year, with various expiry dates up to a period of 11 years. When a substance is registered, the producer and importer of that substance and its compounds must provide the European Chemical Agency (ECHA) with detailed information about the characteristics of the substance and it uses.

The principle behind the REACH Regulation is "NO DATA NO MARKET", so if the required data is not sent to the ECHA within the agreed time limit, it will no longer be possible to produce, import or market the substance and its compounds.
 

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All companies in the ENI share and support the objectives contained in the REACH Regulation which, in general, aim to guarantee that "a high level of protection for people and for the environment will be achieved" and "are based on the principle that producers, importers and end-users are obliged to produce, market and use substances that do not damage the environment or people's health".

ENI recognises the importance of the Regulation, the general principles of which are already a part of ENI's commitment to sustainability and represent an integral part of our company's culture and history.

Representatives of ENI are actively involved in work groups set up as part of various European associations in the sector, such as CEFIC and CONCAWE, ensuring that the provisions of the REACH Regulation are implemented in the best possible way. These work groups are also involved in developing industry guidelines and making sure that everything necessary for registration purposes is available.


In ENI and its companies, individuals with expertise in specific areas (such as  administrative, technical-scientific, computer, legal and commercial) have been involved in setting up and running appropriate organisational structures that integrate the various company areas covered by this regulation.
All ENI companies have pre-registered the substances produced and/or imported, which in total amount to more than 300 and come from the oil and chemical sectors. 
It is envisaged that it will not be necessary to interrupt the production of any substance as a result of the Regulation, and all our companies are involved in ensuring that the substances produced and imported inside the European Union are registered in accordance with the modality indicated in the REACH Regulation and within the appropriate time limits.


Pre-registration

Pre-registration consists of producers and importers presenting a reduced amount of documentation (between 1 June 2008 and 1 December 2008) to the European Chemical Agency (ECHA) which allows these companies to continue producing and importing the substances in question for a transitory phase of a few years before they are required to present the full Registration. The information contained in the pre-registration documentation basically identifies the substance and the company involved, the date the registration expires and the tonnage segment.
Registration
Registration consists of documentation that every producer and importer must present to the European Chemical Agency (ECHA) for every chemical substance or substance that is a component of a compound or article, produced or imported in a quantity equal to 1 ton/year.
The producer and importer must supply all information regarding the dangerousness and risk evaluation of every substance, together with the risk management measures adopted during its production and use and throughout the supply chain. The documentation consists of: technical data containing the identification of the registering company and of the substance, data showing the dangerousness of the substance (chemical-physical, toxicological and eco-toxicological properties), a description of the production process and information about the identified uses; and a Chemical Safety Report containing an evaluation of the health risk for people and for the environment for the substance if produced or imported in quantities equal to 10 tons/year.
Registration is required for monomers but not for polymers.

Evaluation
REACH provides for three types of evaluation. The European Agency (ECHA) carries out:
a conformity evaluation to ensure that the registration dossier is complete, that it includes all the necessary information and that this information is adequate;
an evaluation of the testing proposal to check to see if the trial programme proposed in the registration dossier is necessary.
The member state carries out a more thorough evaluation of the substance in order to ascertain if there is any health or environmental risk.
The member states can also evaluate the registered intermediates.

Authorisation
Authorisation must be requested for each use of the substance or a substance that is a component of a compound or incorporated in articles that cause most concern (carcinogenic, mutagenic or toxic for the reproduction of categories 1 and 2 – CMR 1 and 2; persistents, bio-cumulatives and toxics – PBT; very persistents and very biocumulatives – vPvB; endocrines disruptors), in order to encourage their replacement with less dangerous alternatives if they are economically and technically suitable.

Restrictions
A restriction is any condition or ban attached to the production, use or marketing of a substance or a substance that is a component of a compound or of an article.

Individuals Involved
Producers/importers must demonstrate that they only produce or market "safe" chemical substances, that is those for which the risk related to handling or using them is limited and correctly dealt with in every phase of the substance's life.

Downstream users include formulators, professional users and re-importers. They can provide information in support of the preparation of a Registration and have the right to notify in writing (on paper or in electronic formats) their use to the supplier of the substance as such or as a component of a preparation, with a view to making it a recognised use. At the same time sufficient information should be given so that the downstream producer, importer or user who has supplied the substance can adequately arrange for exposure, or in some cases a category of use or exposure, for use in the evaluation of chemical security.
The same subjects may also arrange for an evaluation of chemical security for uses that have not been communicated by the supplier.
Distributors may also provide information in support of the preparation of a Registration. Moreover, they submit the necessary information for the definition of exposure scenarios to the operator or distributor immediately upstream in the supply chain.


Article
: an object which during its production is given a specific shape, surface or design that determines its function to a greater extent than its chemical composition does.

Use and exposure category: an exposure scenario that covers a vast range of processes or uses, where the processes or uses are described at least in terms of a brief general description of their use.

Distributor: any person or legal person in the European Community, including retailers, who stores or markets a substance or a substance that is a component of a compound in order to sell it to a third party.

Producer: any person or legal person in the European Community who produces a substance inside the Community.

Production: the production or extraction of a substance in its natural state.

Importer: any person or legal person in the European Community responsible for importing goods.

Monomer: a substance that is able to form covalent links with a sequence of added, equal or different molecules to form polymers.

Polymer: a substance whose molecules are characterised by a series of one or more types of monomers. These molecules must be distributed over a range of molecular weights where the difference in molecular weight in mainly due to the difference in the number of monomeric units. A polymer consists of:
a simple ponderal majority of molecules containing at least three monomeric units and having a covalent link with at least one other monomeric unit or another reagent;
less than a simple ponderal majority of molecules of the same molecular weight;
As far as this definition is concerned, a "monomeric unit" stands for a form subjected to the reaction of a monomer in a polymer.

Prepared: a mixture or solution composed of one or two substances

Exposure scenario: the group of conditions, including the operational conditions and the risk management measures, that describes the way the substance produced or used during its life cycle and the way the producer or importer checks or advises the end-user to check the exposure of people and the environment. These exposure scenarios can cover a process or a specific use or a number of processes or a number of uses, depending on the particular circumstances.

Substance: a chemical element and its composites, either in its natural state or obtained by means of production procedure, including the additives necessary to maintain the stability and the impurities deriving from the procedure utilised, but excluding the solvents that can be separated without compromising the stability of the substance or modifying the composition.

Substance subject to a transitory regime: a substance that satisfies at least one of the following conditions:
it is included in European inventory of chemical substances of a commercial character (EINECS);
it has been produced in the European Community, or in countries that adhered to the European Union on 1 January 1995 or 1 May 2004 but have not been admitted to the producers or importers market, at least once in the fifteen years preceding the introduction of the present regulation, on condition that there is documentary proof of this;
it has been admitted to the European Community market or to countries that adhered to the European Union on 1 January 1995 or 1 May 2004 before the present regulation was introduced by producers or importers and it has been notified in accordance with article 8, paragraph 1, first part, of directive 67/548/EEC, but does not correspond to the  definition of polymers contained in the present regulation, on condition that there is documentary proof of this.

Use: any operation concerned with transforming, formulating, consuming, warehousing, conserving, treating, filling containers, transferring from one container to anther, mixing or producing an article or any other use.

Identified use: the use of a substance or a substance that is a component of a compound, or the use of a compound by an individual involved in the supply chain, including use for own reasons, or by an individual notified in writing by another user.

End user: any user or legal person in the European Community who is not the producer or importer who uses a substance, or a substance that is a component of a compound, for industrial or professional purposes. Distributors and consumers are not classified as final users.





Last updated on 14/12/09