Companies with products registered for the Offshore Chemicals Regulations 2002 at CEFAS

Transcription

1 chemicals Energy Development CEFAS Unit (EDU) Fisheries Laboratory association Offshore Environment and Remembrance Avenue Decommissioning Unit (OED) Burnham-on-Crouch EOSCA Bay 2113 Essex 501 North Deeside Road 1 Victoria Street CM0 8HA Cults London SW1H 0ET Aberdeen AB15 9ES Companies with products registered for the Offshore Chemicals Regulations 2002 at CEFAS Ref. EC Chemicals Policy - REACH (Registration, Evaluation and Authorisation of Chemicals) 24th May 2007 Update on REACH european oilfield speciality The REACH Regulation was published in December last year and will enter into force on 1 June The full text of the new Regulation is available from: We therefore thought now would be an ideal time to provide you with a further update on the Regulation and aspects relating to its implementation. The Health and Safety Executive (HSE) has taken on the role of UK Competent Authority and will be working with Defra (overall lead department) on the policy aspects regarding implementation of REACH. The HSE has set up a helpdesk to support business in the run-up to REACH coming into force. The helpdesk can be contacted on or UKREACHCA@hse.gsi.gov.uk. In February, DTI met with Defra / the HSE to discuss general issues relating to the new Regulation and to explore the practicalities of integrating the OSPAR HMCS with the requirements of REACH. A paper summarising the main points from that meeting (which contains important information - particularly with regard to the Preregistration and Registration phases of REACH) is enclosed at Annex 1. We would also like to draw attention to the Defra public consultation (launched in March) on measures for enforcing REACH in the UK. This has been placed on Defra s website: and the closing date for comments is 1 June this year. Although not specifically directed at the offshore oil / gas sector, the consultation provides useful information on REACH and aspects concerning its implementation, which may be of interest to firms that supply substances and preparations to a variety of industrial sectors. The latest timetable for the implementation of REACH is attached at Annex 2. As you undoubtedly recognise, the first phase under REACH concerns the `Pre-registration of substances with the European Chemicals Agency (ECHA). The agency is expected to become operational in June There is a six-month period - 1 June to 1 December for Pre- Registrations to be submitted. We would therefore urge you to start considering (sooner rather than later) the preparation of data for Pre-registration purposes. A list of Pre-registered substances will be made publicly available on the ECHA website on 1 January The Page 1 of 5

2 ECHA intends to accompany the list with the relevant contact details of key players in the chemicals supply chain to encourage the setting-up of consortia for the submission of dossiers under the Registration phase. It is unlikely that the ECHA list will be developed on-line e.g. the ECHA will be keen to receive as many `Pre-registrations as possible in order to establish a comprehensively populated Substance Information Exchange Fora to help with the formation of `substance consortia so that the unnecessary duplication of data during the Registration phase can be minimised - if not totally avoided. We would also like to inform you that at the OSPAR Oil Industry Committee (OIC) meeting in March, the OSPAR Secretariat agreed (in principle) to harmonise the requirements of the HMCS with REACH. To this end, the Secretariat intends to liaise with the EU on this issue and act as a focal point for the dissemination of information to Contracting Parties (the OIC 2007 meeting Summary Record is on the OSPAR website: The Secretariat also plans to prepare a guidance paper which will be submitted to OIC 2008 for discussion. We will therefore, keep you up-to-date on any guidance that is subsequently issued by the Secretariat (although, we would suggest that you do not wait until this guidance is published before making plans for the Pre-registration of substances). In addition to the above, DTI anticipates holding a workshop in Aberdeen - probably during the Autumn - to bring stakeholders up to date with: the progress achieved in implementing the HMCS offshore (including the outcomes of a DTI review to assess the scope for improving the chemical permit application process under the Offshore Chemicals Regulations 2002); the details of any significant changes to the HMCS proposed by OSPAR OIC; and critical aspects pertaining to REACH. We will therefore, contact you later in the year when more detailed information on the proposed Workshop emerges. Finally, the Commission has revised its REACH Q&A document (providing useful clarification on a variety of aspects relating to the different stages of the Regulation) which can be accessed from: ed=0&language=en&guilanguage=en We hope you find this latest update helpful and please contact us if you have any queries. Yours faithfully David Foskett David Foskett Richard Rycroft Graham Payne For DTI for CEFAS for EOSCA david.foskett@dti.gsi.gov.uk r.j.rycroft@cefas.co.uk secretary@eosca.com CC: Mick Borwell Oil & Gas UK Page 2 of 5

3 Arantxa Castanares Halliburton / EOSCA Cassandra Smith Champion Technologies Ian Still - Champion Technologies David Sheahan CEFAS Anthony Millais - CEFAS Evelyn Pizzolla DTI Derek Saward DTI Graeme Cobb DTI Page 3 of 5

4 ANNEX 1 REACH - KEY OUTCOMES OF DTI, DEFRA / HSE MEETING - 13 FEBRUARY 2007 Page 4 of 5

5 REACH KEY OUTCOMES OF DTI, DEFRA / HSE MEETING - 13 FEBRUARY 2007 (A) REACH General information Existing `chemical regimes would sit side-by-side with REACH (e.g. they would need to be brought into line with the new Regulation s provisions). Chemical substances left un-registered according to REACH s criteria would not be able to be manufactured or placed on the EU market (subject to tonnage triggers). REACH enters into force on 1 June Companies (manufactures, suppliers / downstream users) should begin preparing data to submit in their Pre-Registrations to the European Chemicals Agency (ECHA). There is a six-month period (1 June - 1 December 2008) for Pre-Registrations to be submitted A list of Pre-Registered substances will be made publicly available on the ECHA website in January The ECHA intends to provide relevant contact details for all manufacturers / suppliers/ downstream users of a substance to set up the Substance Information Exchange Forum (SIEF) for that substance (as required under REACH for the preparation of joint Registration dossiers). The Registration dossier itself will build on the Pre-Registration data and provide detailed additional information on intrinsic properties e.g. hazard assessments for substances. In REACH tonnage is a proxy indicator for exposure, so the timetable for Registrations, and the level of detail required, will depend on the tonnages of substances produced per year. The largest tonnage band (1,000 + tonnes per year) would complete registrations by 1 December 2010, and the smallest (1 10 tonnes per year) by 1 June If the Pre-Registration phase is missed, then manufactures or importers will be required to register substances immediately (rather than be able to take advantage of the phased registration period), regardless of tonnage, to ensure the substances concerned are permitted market access. Once manufactures / importers had submitted Registrations to the ECHA, Members State Competent Authorities will be informed accordingly. If nothing else was heard from the ECHA within three-months of a Registration dossier being submitted, then this could be considered a `green-light for the continued use of a substance. Where there was a need for substances to undergo the Evaluation phase of REACH, the ECHA will coordinate the actions to be undertaken by Member States. With regard to any Authorisations required for certain risky substances, these will be officially approved by the Commission. Page 1 of 3

6 Authorisations should be sought by manufacturers / suppliers / importers via two routes: (i) the adequate demonstration that substances could be safely used / sufficiently controlled (i.e. deploying the Predicted No Effects Concentration (PNEC) and Derived No Effect Level (DNEL) values); or (ii) the provision of evidence that the socio-economic benefits of using substances outweighed any risks. In either case, Authorisations will have certain conditions attached to them e.g. monitoring, eventual substitution (where suitable safer alternatives were identified), and a review period - the length of which is expected to be set on a case-by-case basis. (B) Integration of the OSPAR HMCS with REACH The requirements of REACH would ultimately replace those of the HMCS for evaluating the environmental impact of chemicals used / discharged offshore, but it is the case that the new Regulation will take several years to fully implement (i.e. chemical substances are subject to the Registration phase up to 11 years from REACH s entry into force). Accordingly, the HMCS approach to regulating the use / discharge of offshore chemicals will be maintained for the foreseeable future. The OSPAR Secretariat has, however, agreed (in principle) that the requirements of the HMCS should be gradually harmonised with the provisions of REACH. A lot of useful data has been generated on chemical substances as a result of the HMCS. It is therefore, recommended that manufacturers / importers of offshore substances try and complete the relevant parts of their Registration dossiers using data acquired to meet existing HMCS requirements. They will then need to consult national authorities or the ECHA, to see if this was sufficient. If such data is considered by the ECHA / its network of national authorities to be insufficient for meeting the environmental protection aspects of REACH, then this should bring to light any further information that needs to be obtained to fully satisfying the REACH Registration process. DTI is in the process of finding `common ground with other OSPAR Contracting Parties on the subject of harmonising the HMCS with the requirements of REACH. In this context, DTI is also currently: (a) working with the Netherlands on the development of a single register for chemicals, which will be useful not only in terms of improving the functionality of the HMCS, but also for acquiring data for the future registering of substances under REACH; and (b) carrying out a review of the UK s implementation of the HMCS to determine if there is any scope for improving the chemical permit Page 2 of 3

7 application process and the `substitution identification criteria of the HOCNF. Suppliers (i.e. manufacturers and importers) of offshore speciality chemicals with production volumes of 1 2 tonnes are particularly concerned that the costs of Registration under REACH will be prohibitively expensive, leading to such products going off-line. However, the 1 10 tonne registration band has eleven years (i.e. to June 2018) to complete registrations, which should help such suppliers by giving them longer to make the necessary arrangements to ensure continuity of supply. In terms of registering substances under REACH, `commercial confidentiality is another area of concern for suppliers of offshore chemicals. The ECHA will expect manufacturers and importers of substances to work together on joint Registrations and in this regard, the One Substance - One Registration (OSOR) procedure is considered a suitable vehicle for providing a good level of protection for commercially sensitive information. DTI is planning to hold a workshop later in 2007 (probably in the Autumn) to provide stakeholders with information regarding the progress made todate on implementing the HMCS. The workshop will also cover important aspects relating to REACH. DTI Energy Development Unit (EDU) Page 3 of 3

8 ANNEX 2 REACH LATEST IMPLEMENTATION TIMETABLE Page 5 of 5

9 REACH Implementation Timeline REACH will apply in stages, taking account of its complexity, the need for industry to adjust accordingly, and to allow a phased transition from the existing regulatory regime to the new regulatory regime under REACH. The Regulation consists of 15 Titles covering the principal elements of REACH, within which specific provisions are contained. Half of the Titles will apply from the entry into force date, with the other half of the Titles applying from one year after entry into force. The table below sets out the implementation timeline for REACH, showing when the Titles apply, and the dates on which specific provisions, reviews, and repeals of existing legislation take effect, or deadlines by which specific actions must be completed Entry into force of REACH 1 June 2007 Titles applying: 1 June I Scope, definitions IV Information in supply chain IX Fees and Charges X European Chemicals Agency XIII Competent Authorities XIV Enforcement XV Transitional arrangements Article 31 provision of information down the 1 June supply chain on substances requiring a Safety Data Sheet. Article 32 provision of information down the supply chain on substances not requiring a Safety Data Sheet Article 115 harmonisation of classification and labelling at Community level for CMRs cat. 1, 2, and 3, and respiratory sensitisers. Repeal of: Directive 91/155/EEC (Information to be included in safety data sheets). Deletion of: Article 14 (provision of safety data sheets) of Directive 1999/45/EEC (Classification, packaging, and labelling of dangerous preparations). At first delivery of such substances after 1 June From 1 June June June Titles applying: II Registration III Sharing of Data V Obligations of Downstream Users VI Evaluation 1 June Page 1 of 4

10 VII Authorisation XI Classification and Labelling Inventory XII - Information Article 74 European Commission Regulation specifying REACH fees and charges adopted. Article 118(3) practical application to REACH of Regulation (EC) No 1049/2001 (regarding public access to European Parliament, Council, and Commission documents). Article 128 free movement of goods within scope of REACH. Article 136 transitional measures regarding existing substances. Article 138(4) Commission review of REACH Annexes I, IV, and V. Article 28 pre-registration of phase-in (existing) substances of 1 tonne+ per year. Repeals of: Directive 93/105/EC (Information required for Technical Dossiers); Directive 2000/21/EC (amending the Dangerous Substances Directive); Regulation (EEC) No 793/93 (Evaluation and control of the risks of existing substances); Regulation (EC) No 1488/94 (principles for risk assessment of existing substances). Article 135 transitional measures regarding notified substances. Article 7 registration and notification of substances in articles. Article 126 Member States provision on penalties for non-compliance with REACH. Article 138(5) Commission review of REACH Annex XIII (adequacy of criteria identifying PBT and vpvb substances). By 1 June By 1 June June June By 1 June June 2008 until 1 December June August December By 1 December By 1 December European Chemicals Agency publishes list of `Pre-registered substances. Title applying: VIII - Restrictions Article 58(3) European Chemicals Agency s first recommendation of priority substances to be included in Annex XIV (list of substances subject to authorisation). Article 67 compliance with existing Marketing and Use restrictions for substances listed in Annex XVII 1 January June By 1 June From 1 June 2009 until 1 June Article 67(3) Commission to compile and By 1 June Page 2 of 4

11 publish an inventory of Annex XVII restrictions. Article 137(3) Commission to incorporate into Annex XVII any amendments to Directive 76/769/EEC restrictions adopted from 1 June Repeals of: Directive 93/67/EEC (Risk assessment for new notified substances); Directive 76/769/EEC (Restrictions on the marketing and use of certain dangerous substances and preparations). Annex XVII List of restricted substances and conditions of restriction Article 117(1) First of 5-yearly Member State reports to Commission on the operation of REACH. Article 23(1) registration provisions for phasein substances for CMR (cat 1 or 2) and toxic (R50/53) over 1 tonne + per year, and other substances over 1000 tonnes per year. Article 116 transitional arrangements for obligations in Article 113 to notify the Agency of substances subject to registration and/or dangerous substances classified as such under existing legislation Article 117(2) First of 5-yearly European Chemicals Agency reports to Commission on operation of REACH. Article 117(3) First of 3-yearly European Chemicals Agency reports to Commission on use of non-animal testing strategies. Article 44(2) European Chemicals Agency to prepare first draft 3-year Community rolling action plan of substances to be evaluated each year Article 117(4) First of 5-yearly general report by Commission on operation of REACH, and funding for development and evaluation of alternative test methods. Article 138(3) Commission review of registration requirements for substances of 1-10 tonnes per year, for Article 117(4) reports. Article 138(6) Commission review of scope of REACH, to avoid overlaps with other legislation. 1 June June June By 1 June December December By 1 June By 1 June December By 1 June By 1 June By 1 June Page 3 of 4

12 Article 43(2)(a) European Chemicals Agency to prepare draft decisions for testing proposals in registrations received by 1 December 2010, complying with Annexes IX and X Article 23(2) registration provisions for phasein substances of 100 tonnes or more per year. Article 138(7) Commission review of whether to exclude endocrine disrupting substances from adequate control authorisations Article 138(1) Commission review of whether to require chemical safety assessments for CMRs cat. 1 or Article 43(2)(b) - European Chemicals Agency to prepare draft decisions for testing proposals in registrations received by 1 June 2013, complying with Annex IX only Article 23(3) - registration provisions for phase-in substances of 1 tonne or more per year Article 138(1) - Commission review of whether to require chemical safety assessments for substances exempt from REACH, or in quantities of less than 10 tonnes per year. Article 138(8) Commission review whether to extend duty to communicate information on substances in articles to other dangerous substances, in addition to CMRs, PBTs, vpvbs, and endocrine disruptors already covered. Article 138(9) Commission review of reproductive toxicity testing requirements (Annex VIII, section 8.7), to ensure minimisation of animal testing Article 43(2)(c) - European Chemicals Agency to prepare draft decisions for any testing proposals in registrations received by 1 June By 1 December June By 1 June By 1 June By 1 June June By 1 June By 1 June By 1 June By 1 June Page 4 of 4