REACH is an acronym created from the words Registration, Evaluation and Authorisation of Chemicals. The essence of the EU's new regulation of chemicals is that contrary to the old system the duties of producers/importers and authorities related to chemical substances are fundamentally changed by one regulation.
About REACHREACH is an acronym created from the words Registration, Evaluation and Authorisation of Chemicals. The essence of the EU's new regulation of chemicals is that contrary to the old system the duties of producers/importers and authorities related to chemical substances are fundamentally changed by one regulation.
According to the old directives the so-called old chemical substances (100,106 pcs) already used, and reported on the date of 18th September 1981, were listed on the EINECS list (European Inventory of Existing Commercial Chemical Substances) and could have been distributed freely. The new, updated and improved regulation about the registration, evaluation, authorisation and restriction of chemical substances i.e. REACH entered into force on 1st June 2007. According to REACH the registration documentation of existing substances has to be submitted
* within three years from REACH entering into force for CMR (carcinogenic, mutagenic or reprotoxic) substances produced/imported above 1000 tonnes p.a.;
* within six years above 100 tonnes p.a.; and
* by the end of the eleventh year above 1 tonne p.a.
This is one of the new features of REACH. Practically this means that all substances produced or imported (from outside the EU!) by a company in a quantity above one tonne per year have to be registered at ECHA (European Chemicals Agency) together with information depending on quantity. "All substances" means that we are not only talking about the hazardous ones but about everything that can be covered by the term "substance". It is very important that substances in preparations imported (from outside the EU!) have to be registered also in case the quantity of the substance in the preparation exceeds one tonne p.a.
Chemical industry put on the market an unbelievable variety and quantity of new substances in the past hundred years. The mandatory notification system for chemical substances entered into force in the area of the European Union (EU) only on 18th September 1981. Roughly three thousand new substances were only reported since then, and another approx. 100 000 chemical substances are produced without any formal permit and records through the market entry before 1981. I.e. we have practically no idea about the features – especially the impact on human health – of approximately 97% of chemical substances on the market. REACH intends to change this situation by introducing the registration obligation covering all substances. (Further information on REACH and ECHA can be found on the links quoted below.)
The objectives of REACH:
* to improve the protection of human health and the environment from the incidental hazards of chemical substances
* to increase the competitiveness of the chemical industry which is a key sector of the EU economy
* to support alternative examination methods that survey hazards related to substances
* to ensure the free distribution of substances in the internal market of the EU.
Effects of REACH
Based on the preliminary studies of the European Commission, REACH represents a 4-5 billion euros expenditure for the chemical industry and subsequent users in the 10-15 years following its introduction. On the other hand the benefits of the introduction of REACH could even amount to 50 billion euros in 30 years, according to the studies. The benefits will be realised first of all in the healthcare budgets through the reduction of the number and seriousness of illnesses. According to expectations the number of respiratory illnesses, leukemia, skin diseases, allergies and cancer – among others – will be reduced thanks to REACH. Benefits for the environment include the reduced contamination and environmental load of waters, soil and the air.
Regarding direct economic impacts it will probably be the small to medium sized companies producing and distributing many different chemical products that would feel the negative side through the increase of their costs. The population will experience a minimal price increase but it will be compensated by the healthcare and environmental benefits that will also be felt by the population in the long run. The introduction of REACH will trigger the research and development activity of the chemical industry and will improve the work
safety of chemical companies as well as the judgement of their activities by the society.
The Operation of REACH
The new regulation draft, REACH basically introduces three new ideas: on the one hand it eliminates the categories of old and new substances, and producers and importers must register all chemical substances again after the regulation enters into force, by the tests stipulated (Registration – Evaluation).
On the other hand, so far general chemical substance regulations were applicable to those chemical substances only that were put on the market by producers or importers. Furthermore, separate regulations controlled the production process itself: workplace limit values, activity permits, emission limits, uniform environment utilisation permits, chemical safety in the workplace, etc.). Contrary to that in case of REACH any kind of treatment of chemical substances comes under its effect but naturally the previously mentioned rules will not be eliminated.
The third basic change is that instead of the authorities, producers and importers will have to evaluate the risks of individual applications and to inform users accordingly. What's more, particularly hazardous substances – the scope of which will be predetermined by the authorities – can be used for authorised applications only (Authorisation).
Producers and importers have the opportunity in the last preparation phase following the 1st June 2007 entering into force of REACH to pre-register substances that they intend to produce and distribute in the future also. Those who don't take the opportunity of pre-registration will have an immediate registration obligation following 1st December 2008 which means that they can only produce and distribute their products if they completed the registration process through ECHA. In other words the omission of pre-registration has the consequence that the activity is restricted until registration is done. Companies taking the opportunity of pre-registration have an extended grace period for the compilation and approval of the complete registration dossier till 2010.
The (Pre-)Registration Policy of TVK
Under the above legislation it was vital for TVK to have its products successfully accepted by the European Chemicals Agency in the pre-registration phase; otherwise the company would have been forced to restrict its activities after the first of December. Accordingly, TVK – as the first of the business divisions of the MOL Group to do so – successfully pre-registered its products concerned with ECHA.
Pre-registrationManufacturers and importers must pre-register substances that are already on the EU market (so-called phase-in substances), if they want to benefit from transitional arrangements that allow registering them at a later stage. Pre-registration also enables registrants to share data with other registrants and avoid carrying out redundant tests. The pre-registration period is limited from 1 June 2008 to 1 December 2008.
Referring to your request on REACH compliance we would like to inform you, that according to the „ TITLE I, Article 2, Item 9“ of the REACH „Regulation Nr. 1907/2006 of the European Parliament and of the Council of 18th December 2006”, polymers are released from the registration obligation. It is a great pleasure for us to inform you that hydrocarbon monomers of our manufactured polymers (Tipolen, Tipelin, Tipplen) are pre-registered.
Tisza Chemical Group Public Limited Company submitted its pre-registration and got the submission number PP230100-45. The pre-registered monomers and their identification numbers are as follows:
We intend to register these monomers until the end of 2010 as well. Concerning the additives incorporated into manufactured polymers, we can also confirm that we will use only such additives which will be pre-registered and registered in accordance with REACH. Suppliers of Tisza Chemical Group Public Limited Company (including producers of catalysts, polymer additives) were already contacted in order to clarify their intention to comply with REACH pre-registration and registration requirements.
Krisztina Petrényi Szabó (Deputy-CEO)
Tamás Koczor (SD & HSE manager)
RegistrationREACH requires manufacturers and importers of chemical substances (larger than or equal to 1 tonne/year) to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these substances can be used safely. Each manufacturer and importer must submit a registration dossier documenting the data and assessments to the EU Chemical Agency (ECHA).n Non-EU legal entities can not register substances, except via a competent “only representative”.
SIEF (Substance Information Exchange Forum)The aims of the SIEF are to facilitate data sharing for the purposes of Registration, thereby avoiding duplication of studies (esp. vertebrate testing), and agree on the classification and labelling of the the substances concerned where there is a difference in the classification and labelling of the substance between the Potential Registrants. Membership is mandatory for all pre-registrants of a substance.
Classfication and labelling inventoryA classification and labelling inventory will be developed from notifications submitted by industry on substances classified as dangerous (including those below 1 ton/year) and from information on classification and labelling included in registration dossiers.
Communication in the supply chainSuppliers of substances must pass on information on the health, safety and environmental properties and on the safe use of their chemicals to their downstream users (via a Safety Data Sheet or other means).n Downstream users may only use substances classified as dangerous or which are persistent, bioaccumulative and toxic (PBT and vPvB) if they apply risk management measures identified on the basis of exposure scenarios for their use.
Referring to your request on REACH compliance we would like to inform you, that according to the „ TITLE I, Article 2, Item 9“ of the REACH „Regulation Nr. 1907/2006 of the European Parliament and of the Council of 18th December 2006”, polymers are exemted from the registration obligation. It means that we do not have to prepare use and exposure scenarios for polymers supplied to you by us. The same result is achieved with taking into consideration – thorough another approach – that our polymers are not dangerous therefore there is no requirement to prepare an exposure assessment according to the Title I of the REACH regulation.
The hydrocarbon monomers of our manufactured polymers (Tipolen, Tipelin, Tipplen) are pre-registered as required by Article 6.3 of the REACH regulation, and we intend to register these monomers until the end of 2010 as well. Of course for these monomers we prepare - common with the Low Olefins and Aromatics Consortium - exposure scenarios and determine uses which will be registered. This is a long process and it is managed by LOA consortium but we confirm already now that only the use for polymer manufacturing will be covered in the dossier as a final step of the life cycle of the monomers. Concerning the additives incorporated into manufactured polymers, we informed our Suppliers (including producers of catalysts, polymer additives) on our uses (polymer manufacturing) and requested to add it in their registration dossiers. Because of our final products containing these additives are not dangerous, we do not need to communicate your uses back to our additives suppliers neither the SDSs recieved from them to you.
Regarding polymers you can find safety data sheets on our website (www.tvk.hu) which contain use information on these substances (1.2 point). Using our finder on the website you can simply obtain more information about application areas as well.
Krisztina Petrényi Szabó (Deputy-CEO)
Tamás Koczor (SD & HSE manager)
Technical dossierFor the registration of substance the registrant must submit a technical dossier with the information on the properties, uses and on the classification of a substance and also guidance on safe use. The required information is defined in Annex VI.
Chemical Safety Report (CSR)The registrant must perform a chemical safety assessment and prepare a chemical safety report for all substances if he manufactures or imports the substance in quantities of 10 tons or more per year.
EvaluationThe Agency will perform dossier evaluation to assess testing proposals made by the registrant and/or to check that the Registration dossiers comply with the requirements. The Agency will also co-ordinate substance evaluation, which will be conducted by the Member States to investigate chemicals of concern.
AuthorizationAuthorization will be required for the prioritized substances of very high concern (SVHC) that are included in Annex XIV. n Companies applying for authorization will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks. n Applicants will also have to investigate the possibility of substituting these substances with safer alternatives or technologies, and prepare substitution plans, if appropriate.
Date of issue: 12. 07. 2010.
Rev. number: 07.
(Updated on 18/06/2010)
RestrictionsThe European Union can impose restrictions and prohibit or set conditions for the manufacture, placing on the market or use of certain dangerous substances or group of substances if unacceptable risks to humans or the environment have been identified.