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REACH - New European Policy on Chemical Substances
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Scope of REACH
On 30.12.2006 the European Regulation no. 1907/2006 (REACH), which introduces a new policy on chemicals management issues, was published in the Official Journal of the European Union. This Regulation is the result of increased sensitivity within the European community for the conservation of the natural environment and the protection of human health from dangerous chemical substances, through mechanisms that will preserve the competitiveness of the European chemical products market. On the social level, the main aim of the new policy is the protection of the health and safety of employees in a suitable working environment, where chemical substances will be used in a controlled way and their negative effects on human health and the environment will be minimized. The date of entry into force of REACH was the 1st of June 2007. Specific provisions of the regulation will be gradually entered into force by the Member States by 2018.
Additional informative material concerning the new European regulation REACH can be found on the website of the European Chemicals Agency (ECHA):
http://echa.europa.eu
Pre-registration
All manufacturers and importers of chemicals in quantities of one tonne per year or more (in pure form, as constituents of preparations or as parts of articles from which the chemicals are indented to be released), who began production/import after the 1st of December 2008, have to declare (pre-register) the amount and the type of the chemicals they manufacture or import respectively, to the European Chemicals Agency (ECHA). This late pre-registration is free, is performed on ECHA´s webpage online through the REACH-IT software, and is obligatory for the manufacturers or the importers who wish to continue the manufacture, import and placing on the market of those chemicals. The term «import» implies the physical introduction of a chemical from a non European country into the customs territory of the European Community. More information on the pre-registration procedure is available on the «Practical Steps for Pre-registration» Document and at the following specially designed webpage of the European Chemicals Agency:
http://echa.europa.eu/pre-registration_en.asp
Registration
Manufacturers and importers who will proceed with the pre-registration of the chemicals they trade, will be able to benefit from the extended registration deadlines. The registration of a chemical includes the preparation of a technical dossier with data about the dangerous effects of that chemical to the human health and the environment. The dossier is submitted to ECHA. Through the REACH-IT software all the potential registrants of a chemical will be able to come in contact through the Substance Information Exchange Forum (SIEF) of the substance, exchange the data they hold and submit a joint registration dossier about that substance, by sharing also the respective registration fee. The final registration deadlines for substances which are listed in the European chemical Substances Information System (ESIS) are:
- For substances of 1000 tonnes or more per year, or for substances over 1 tonne/year classified as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, or for substances over 100 tonnes/year classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment: 30 November 2010.
- For substances between 100-1000 tonnes/year: 31 May 2013.
- For substances between 1-100 tonnes/year: 31 May 2018.
Substance Information Exchange Forums (SIEFs)
Joining a Substance Information Exchange Forum (SIEF) is a legal obligation of all registrants. SIEFs are formed by companies that intend to register the same substance to facilitate the sharing of information, avoid duplication of new studies and agree on classification and labelling if necessary.
A SIEF (Substance Information Exchange Forum) will be formed for each pre-registered substance with the same identity because companies who pre-registered a substance automatically became listed on the pre-SIEF page of this substance. Based on a detailed consideration of the substance identity, companies in each pre-SIEF must decide whether their substance can be regarded as the same. To help you to look for other potentially similar substances, you can use the “similar substances” tab in the pre-registration page. You will then find other pre-SIEFs.
Each potential registrant will be able to see through the REACH-IT who has pre-registered the same substance, therefore you can become active by communicating with other SIEF members.
SIEF members need to nominate a Lead Registrant, who will share and assess data and prepare common parts of the registration (joint submission). The company acting as the Lead Registrant will submit the joint submission (JS). The JS is made on behalf of all the registrants. Each registrant then needs to indicate the correct JS name in his own IUCLID 5 dossier together with their company-specific information, which must be submitted separately after the JS has been made.
The data sharing fees which will be agreed among the members of each SIEF will be paid separately and additionally of the fees to be paid to ECHA for the submission of a joint registration.
You need to join a SIEF now if you intend to register by 1 December 2010.
If you decide to postpone your registration or you do not need to register, you can change your SIEF status from active to inactive. You can do this in REACH IT.
Guidance Document and NAVIGATOR
An online Navigator has been prepared by the European Commission for helping the producers and the importers of chemical substances to find out their obligations under REACH. By answering a series of questions about the type of the chemical substances, their uses and quantities, the manufacturers / importers will be able to know whether they have an obligation to preregister these substances. The Navigator is available online at the following website:
http://guidance.echa.europa.eu
On the same website one can find all the Guidance Documents for the implementation of REACH Regulation. The Guidance Documents contain extensive information and Best Available Practices on the implementation procedures of the REACH Regulation, for producers and importers of chemical substances and for Member States competent authorities at the following address:
http://reach.jrc.it/guidance_en.htm
Frequently Asked Questions-Further Guidance
Further answers to questions that may arise concerning the new Regulation REACH are displayed on the Frequently Asked Questions document. For answers to questions related to the REACH-IΤ software click here. Further information about the fees set by REACH is available on the European Regulation 340/2008/EC and on the following website of the European Union:
http://ec.europa.eu/enterprise/reach/reach/fees/index_en.htm
For additional information you may contact the Reach Helpdesk for Cyprus at the following email address: Reach@dli.mlsi.gov.cy
Amendments of REACH Regulation
REACH Regulation was amended after the new European Regulation 1272/2008/EC on classification, labelling and packaging of substances and mixtures (CLP) entered into force on 20.1.2009. For unofficial consolidated version of REACH click here. REACH annexes were amended by the following European Regulations/Decisions:
987/2008/ΕC Amendment of Annexes IV and V
134/2009/ΕC Amendment of Annex XI
552/2009/ΕC Amendment of Annex XVII
424/2009/ΕC Amendment of Annex XVII (Paraffin oils, grill lighter fluids)
425/2009/ΕC Amendment of Annex XVII (Organostannic compounds)
455/2009/ΕC Amendment of Annex XVII (Dichloromethane)
453/2010/EC Amendment of Annex II (Safety data Sheets)
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 Commission Recommendation on Definition of SMEs.pdf (123.58 Kb)
REACH REGULATION english.pdf (1857.05 Kb)
ECHA Practical-steps_EN.pdf (214.59 Kb)
ECHA Pre-registration Leaflet EN.pdf (255.82 Kb)
Testing Methods Regulation.pdf (6629.74 Kb)
Annex V_Draft Guidance.pdf (200.48 Kb)
20090213-Corrigendum_REACH-EN.pdf (32.03 Kb)
2009_761_Reg_EN.pdf (2600.82 Kb)
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