Hello and welcome to the October edition of The REACH Centre newsletter. The pre-registration window for phase-in substances is drawing to a close and you need to take action now if you have still not pre-registered or appointed an Only Representative to pre-register for you if you are outside the EU. To find out how The REACH Centre can help, please visit our website.

In this newsletter, we will look at the latest REACH news from the EC (European Commission) and the ECHA (European Chemicals Agency), and inform you of the latest news from The REACH Centre. We also focus on what an Only Representative is and how you can appoint one.

The ECHA is currently finalising the candidate list of chemicals that present the most cause for concern regarding public health and the environment, with a target date for publication of 22nd October.

This list will contain Substances of Very High Concern (SVHC), such as chemicals that cause cancer, birth defects and other serious health defects and which persist in the environment and accumulate in our bodies.

The first chemicals on this candidate list will be put on a priority list and will undergo intensive testing before they are authorised under the REACH legislation. It is expected that only twelve substances will make it onto the list initially, but Geert Dancet, executive director of the European Chemicals Agency (ECHA), said "I want to be very clear that the candidate list is a living list," adding that the ECHA wishes to update and add new substances to the list "at least once a year".

The publication of the list will help companies identify whether they use any Substances of Very High Concern, and plan for substitution of these substances in their products before the substance becomes the subject of Restriction under REACH.

Additionally, public interest groups and NGOs have jointly drafted a SIN ("Substitute It Now") List (http://www.chemsec.org/list/) of some 270 substances that they believe should be subject to greater controls through the authorisation process (i.e. considered to be ‘substances of very high concern'); this was in part a reaction to the very short list of substances being considered for the first candidate list. The SIN list has no regulatory status but may influence some stakeholders in substituting harmful substances with safer alternatives.

ECHA urges companies to only pre-register substances they intend to register

As of 15th September 2008, the ECHA had received 352,641 pre-registrations from 30 countries. However, the ECHA believes that a number of these pre-registrations may not be valid. The agency is reminding companies that before they submit a pre-registration REACH-IT requires them to declare that the substances they intend to pre-register are phase-in substances within the meaning of Article 3 (20) of the REACH Regulation. Certain pre-registrations the ECHA has received are in breach of Article 3 (20) of REACH and companies who have submitted such pre-registrations may therefore be subject to enforcement actions by the authorities of the relevant Member States.

One UK company pre registered the entire EC inventory (EINECS, ELINCS and NLP), using the bulk pre-registration functionality, in 5 days. This impacts heavily on the usefulness of the list of pre-registered substances, and in particular for downstream users, who can notify the Agency of their interest in a substance not appearing on the list of pre-registered substances, according to Article 28(5) of REACH.

The ECHA has received several complaints on this issue from chemical companies, who fear that the data sharing will become unmanageable if this example is followed. ECHA is considering preventive actions, such as limiting the number of pre-substances that a company may pre-register without prior confirmation from ECHA.

The preliminary list of pre-registered substances is scheduled to be published later this month.

EU regulation on Classification, Labelling and Packaging of substances and mixtures to implement the GHS

On 3 September 2008 a large majority of the European Parliament (EP) supported the "compromise package" for a new Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP) implementing the United Nations Globally Harmonised System (GHS) for the classification and labelling of chemicals.

The CLP Regulation will complement REACH and ensure that the same hazards will be described and labelled in the same way all around the world. It will, after a transitional period, replace the current rules on classification, labelling and packaging of substances (Directive 67/548/EEC) and mixtures (Directive 1999/45/EC). After entry into force, the deadline for substance classification according to the new rules will be 1 December 2010 and for mixtures 1 June 2015.

The EP also voted with a large majority on two related acts which aim to adapt further Community acts to the new rules on classification and labelling. These had been approved by COREPER on 23 July 2008.

The next step in the co-decision process will be the final adoption of the CLP Regulation and the two related acts in Council. This is currently scheduled for 18 November 2008. Publication of the adopted acts in the Official Journal of the European Communities is foreseen for late 2008.

REACH news in brief

• The first ‘service release' (SR1) for IUCLID 5 is planned to be made available to the public in October. This ‘service release' will fix some minor issues concerning screen layout, print out errors, etc. It will also enable IUCLID5 to be run in a Windows Vista environment.
• ECHA has launched a new section, ECHA CHEM, on its website; this will provide information and documents from the various REACH processes as they move forward. ECHA-CHEM-DATA can be accessed at: http://echa.europa.eu/chem_data_en.asp

If you are a non-EU manufacturer, and wish to secure your position in the market, you should consider appointing an "Only Representative" to (pre)register your substances under REACH.

Only Representatives are natural or legal persons established in the EU who are appointed by non-EU Manufacturers to fulfil the obligations of Importers.

The REACH Centre can act as your Only Representative. Our consultants are among Europe's leading REACH experts and their in-depth regulatory knowledge is reinforced with excellent technical and legal expertise, both in-house and through strong links with other affiliated companies and research institutes.

Our fully comprehensive service includes pre-registration of your substances, Submission of the registration dossier in accordance with the deadlines, management of all formal communication with ECHA and MS (Member States), maintenance of records relating to the client's EU importers and their individual annual tonnages, and the passing of information relating to REACH compliance up and down the supply chain.

As your Only Representative in the SIEF, we will:

• Carry out pre-SIEF substance sameness checks
• Advise on and conduct (pre) SIEF negotiations on cost sharing agreements and working arrangements
• Advise on SIEF strategies and tactics
• Advise on validity and suitability of data and tests
• Advise on milestones and deadlines associated with registration
• Participate in SIEF meetings in line with your instructions

In addition, our team of regulatory and technical experts can offer a wide range of services including data interpretation, data gap analysis, hazard assessment, advice on data waiving, PBT and vPvB assessment, preparation of chemical safety assessments and reports (CSA/R) and generation of safety data sheets (SDS).

To find out how to access our Only Representative service, and to get a quote, please visit our website.

The REACH Centre team

Cherrie Whiteley joins The REACH Centre

The REACH Centre has taken on another member of staff. Cherrie Whiteley will take responsibility for co-ordinating projects within the organisation, and will be managing our public funded and UK regional government projects.

Cherrie is also heading up our long-term service provision for chemical safety assessments and reports (CSA/CSR) and safety data sheets (SDS).

Cherrie previously worked in the banking industry involved in eProcurement, compliance and regulation. She has since completed a Masters degree at Lancaster University, in Environmental Science.

REACH training courses success

The REACH Centre, in conjunction with the Lancaster Environment Centre, has recently conducted two training courses covering many aspects of REACH. Both courses were fully booked. Managing REACH was presented by Simon Brearley and Dr. Matteo Dalla Valle of The REACH Centre, and covered pre-registration and registration, alongside a demonstration of REACH-IT and IUCLID5. Delegates commented that "the course was a real eye-opener" and provided a "good insight into REACH".

The IUCLID5 training course was co-presented by Dr. Matteo Dalla Valle and Dr. Andy Sweetman of the Lancaster Environment Centre.  It focussed on applying IUCLID5 in line with REACH and was a fully interactive session held in one of Lancaster University's IT training suites.

New dates are now available on these courses: see below for details.

The REACH Centre is now offering online REACH training

The REACH Centre can now deliver online webinars to companies who need a bespoke REACH training solution but can't travel to our regular training events.

Our webinars can cover a wide variety of REACH topics, and can be specifically tailored to your company's requirements. All presentations are made by members of our REACH technical team.

The webinars typically last for 90 minutes and have set breaks during which the presenter can answer any questions arising. If there are any more complex questions you have, these can be typed into our interactive forum during the presentation and they will be answered in-depth at a later date.

For more information about our webinars, and a quotation, please visit our website.

Training and education surrounding REACH legislation is vitally important to ensure organisations get it right with minimal expense and upheaval. We offer a wide selection of training solutions ranging from REACH workshops through to bespoke programmes.

Working effectively in SIEFs and Consortia

Date - Thursday 16th October 2008
Venue - Lancaster University Campus
Cost - £250 per person

This workshop provides a balanced overview of the legal responsibilities and the practical business issues involved when working in SIEFs and Consortia

Read more [PDF] :: Booking form

IUCLID5

Date - Wednesday 12th November 2008
Venue - Lancaster University Campus
Cost - £445 per person

The day focuses on hands-on experience in applying IUCLID5 in line with REACH and delivered by two experienced IUCLID5 trainers with REACH expertise. This course is very interactive and full of useful exercises.

Read more [PDF] :: Booking form

REACH Management for Chemical Users

Date - Tuesday 18th November 2008
Venue - Lancaster University Campus
Cost - £250 per person

Much of the focus of REACH awareness training has been on the obligations of manufacturers and importers of chemicals into the EU. However, all organisations which use chemicals have specific compliance responsibilities which need to be understood and managed. This course provides an opportunity to understand these obligations and act on them.

Read more [PDF] :: Booking form

There are limited spaces available on these courses so book early to guarantee your place.

The REACH Centre can also provide bespoke IUCLID5 training tailored to your needs. For more information, please contact m.dallavalle@thereachcentre.com

The REACH Centre can support your REACH needs through the Regional Integrated Support Programme (RISP).

RISP provides part-funded support to businesses in the Northwest of England delivered through a variety of methods including:

• Direct Consultancy (at substantially reduced rates with REACH experts)
• Initial Awareness
• Impact Assessments
• Action Planning
• Workshops (minimal cost & free to Chemicals Northwest members)

The REACH Regional Integrated Support Programme (RISP) aims to assist companies in the Northwest of England to better manage their compliance with REACH, a far-reaching and complex new piece of legislation concerned with the way chemicals are manufactured, used and managed.

The RISP programme is delivered by The REACH Centre and Lancaster University, co-ordinated by Chemicals Northwest, and part funded by the NWDA. As part of the integrated support available in the Northwest, you can gain support from a variety of other sources: please visit our website for contact information.

For information on how your organisation could benefit from RISP, and to enable us to assess your needs and determine your eligibility for the programme, please visit our website.

Don’t forget The REACH Centre offers a wide range of REACH services, including pre-registration, registration, Only Representative and Third Party Representative services.