- Email: [email protected]
EU Parliament adopts REACH
March 2007
ENVIRONMENT, HEALTH & SAFETY ISSUES EU Parliament adopts REACH The final months of 2006 saw intense activity in an attempt to achieve the second reading of the European Union’s REACH (Registration, Evaluation and Authorization of Chemicals) legislation in the European Parliament by the end of the year. The draft version of REACH passed its first reading in November 2005 but a number of the amendments agreed by Parliament were subsequently resisted by a majority of the 25 EU member states, represented by the council of ministers, and, indeed, many groups within Parliament itself. Chief among the outstanding issues affecting the chemical industry were the degree to which REACH should embrace the substitution principle – whether industry should be forced by the withdrawal of authorization to abandon ‘problematic’ substances when safer alternatives are available, or just encouraged to replace them – the degree of due diligence required from industry, and the promotion of alternative, non-animal test methods. Authorization itself proved another contentious issue, with Parliament pushing for a five-year time limit (after which period companies would have to seek re-authorization for problem substances) and many lobby groups opposing the imposition of any such time limits once authorization has been granted. The need for an overhaul of the EU’s chemical legislation has not been in dispute, with some 40 separate pieces of legislation concerning chemicals currently on the statutes – which REACH will replace – but achieving a consensus position between the opposing sides required intense and lengthy compromise negotiations within Parliament and between MEPs and ministers. At various junctures delays and even formal conciliation procedures looked inevitable, particularly when, in October last year, Parliament’s influential environment committee reaffirmed its strong endorsement of the original set of first reading amendments, with no concessions on mandatory substitution or authorization. However, last-ditch talks achieved a deal between MEPs and the EU ministers on 1 December, clearing the way for
Additives for Polymers
EVENTS CALENDAR 24–27 April 2007 Amsterdam, The Netherlands BFR 2007 International Workshop on Brominated Flame Retardants Prof. Jacob de Boer; e-mail: [email protected]; URL: www. bfr2007.com/default.asp 24 April 2007 Bristol, UK The Plastics Industry Strategy Seminar Applied Market Information Ltd, AMI House, 45-47 Stokes Croft, Bristol BS1 3QP, UK; tel: +44-117-924-9442; fax: +44-117-989-2128; e-mail: [email protected]; URL: www. amiplastics.com 25–27 April 2007 Baltimore, MD, USA CPMA International Color Pigments Conference 2007 Color Pigments Manufacturers Association Inc, 300 North Washington St, Suite 102, Alexandria, VA 22314, USA; tel: +1-703684-4044; fax: +1-703-684-1795; e-mail: [email protected]; URL: www.pigments.org 3 May 2007 Brussels, Belgium The Plastics Industry Strategy Seminar Contact details as above 6–10 May 2007 Cincinnati, Ohio, USA ANTEC 2007 & Plastics Encounter Society of Plastics Engineers, Conference Department, 14 Fairfield Drive, PO Box 403, Brookfield, CT 06804-0403, USA; tel: +1203-775-0471; fax: +1-203-775-8490; e-mail: [email protected]; URL: www.4spe.org 22–23 May 2007 Frankfurt, Germany Blowing Agents and Foaming Processes 2007 Conference Dept, Rapra Technology, Shawbury, SY4 4NR, UK; tel: +44-1939250383; fax: +44-1939-252416; e-mail: [email protected]; URL: www.rapra.net
11
the second reading vote in Parliament on 13 December, where the compromise package was backed by more than 70% of members. Opposition from the Netherlands, Poland and particularly Germany, where a powerful lobbying exercise was led by BASF, successfully overruled the demands for mandatory substitution. The agreed deal broadly accepts that Europe’s chemicals industry can continue to use between 1500 and 2000 ‘substances of high concern’, provided that processes are ‘adequately controlled’, a principle that has long been championed by the chemical industry lobby. The revised REACH regulation now requires producers and importers to present an analysis of possible alternatives to hazardous substances. If alternatives are available, the applicants must produce ‘substitution plans’ showing how they intend to phase out the hazardous substance. If alternatives are not available, the applicants must present an R&D programme aimed at finding alternatives. In addition, it is proposed that some 17 000 existing substances produced in small quantities will be either exempted from REACH or subject to less-stringent safety data requirements. This and the new substitution plans will result in a consequent reduction in testing requirements, another area of concern. Sharing of data on animal testing will also be encouraged. A further change to benefit industry sees the length of time that commercially sensitive data should remain confidential doubling from three to six years. Finally, a contentious declaration that producers and importers have a general duty of care to prevent harm has been moved from the body of the REACH legislation to a declaratory preamble, allaying legal concerns because of differences in liability laws in EU member states. All in all, these compromises go a long way towards meeting the concerns of the chemical industry. REACH will now enter into force around June this year, with the new rules being phased in over the next 11 years. The new European Chemicals Agency (ECHA) being established in Helsinki, which will in due course handle registration applications and safety data for an estimated 30 000 widely used substances (i.e. those used or imported by a company in quantities >1 tonne/year), will become fully operational in mid-2008. It is expected to make its first series of recommendations on the most hazardous substances by mid-2009. Subscription price for one year including first class airmail delivery (12 issues): US$1343/¥159,400/1201 (Payments in other currencies are subject to our prevailing exchange rate). (Prices valid to end of 2007)
Editorial office:
Subscription enquiries, orders and payments:
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This journal and the individual contributions contained in it are protected under copyright by Elsevier Ltd 2007, and the following terms and conditions apply to their use: Photocopying Single photocopies of single articles may be made for personal use as allowed by national copyright laws. Permission of the publisher and payment of a fee is required for all other photocopying, including multiple or systematic copying, copying for advertising or promotional purposes, resale, and all forms of document delivery. Special rates are available for educational institutions that wish to make photocopies for non-profit educational classroom use. Permissions may be sought directly from Elsevier Rights & Permissions Department, PO Box 800, Oxford OX5 1DX, UK; phone: (+44) 1865 843830, fax: (+44) 1865 853333, e-mail: [email protected]. You may also contact Rights & Permissions directly through Elsevier's home page (http:// www.elsevier.com), selecting first 'Customer Support', then 'General Information', then 'Permissions Query Form'. In the USA, users may clear permissions and make payments through the Copyright Clearance Center, Inc, 222 Rosewood Drive, Danvers, MA 01923, USA; phone: (978) 7508400, fax: (978) 7504744, and in the UK through the Copyright Licensing Agency Rapid Clearance Service (CLARCS), 90 Tottenham Court Road, London W1P 0LP, UK; phone: (+44) 207 436 5931; fax: (+44) 207 436 3986. Other countries may have a local reprographic rights agency for payments. Derivative Works Subscribers may reproduce tables of contents or prepare lists of articles including abstracts for internal circulation within their institutions. Permission of the publisher is required for resale or distribution outside the institution. Permission of the publisher is required for all other derivative works, including compilations and translations. Electronic Storage or Usage Permission of the publisher is required to store or use electronically any material contained in this journal, including any article or part of an article. Contact the publisher at the address indicated. Except as outlined above, no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission of the publisher. Address permissions requests to: Elsevier Rights & Permissions Department, at the mail, fax and e-mail addresses noted above. Notice No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. Although all advertising material is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement of the quality or value of such product or of the claims made of it by its manufacturer. Printed by Mayfield Press, UK
02061
ENVIRONMENT, HEALTH & SAFETY ISSUES EU Parliament adopts REACH The final months of 2006 saw intense activity in an attempt to achieve the second reading of the European Union’s REACH (Registration, Evaluation and Authorization of Chemicals) legislation in the European Parliament by the end of the year. The draft version of REACH passed its first reading in November 2005 but a number of the amendments agreed by Parliament were subsequently resisted by a majority of the 25 EU member states, represented by the council of ministers, and, indeed, many groups within Parliament itself. Chief among the outstanding issues affecting the chemical industry were the degree to which REACH should embrace the substitution principle – whether industry should be forced by the withdrawal of authorization to abandon ‘problematic’ substances when safer alternatives are available, or just encouraged to replace them – the degree of due diligence required from industry, and the promotion of alternative, non-animal test methods. Authorization itself proved another contentious issue, with Parliament pushing for a five-year time limit (after which period companies would have to seek re-authorization for problem substances) and many lobby groups opposing the imposition of any such time limits once authorization has been granted. The need for an overhaul of the EU’s chemical legislation has not been in dispute, with some 40 separate pieces of legislation concerning chemicals currently on the statutes – which REACH will replace – but achieving a consensus position between the opposing sides required intense and lengthy compromise negotiations within Parliament and between MEPs and ministers. At various junctures delays and even formal conciliation procedures looked inevitable, particularly when, in October last year, Parliament’s influential environment committee reaffirmed its strong endorsement of the original set of first reading amendments, with no concessions on mandatory substitution or authorization. However, last-ditch talks achieved a deal between MEPs and the EU ministers on 1 December, clearing the way for
Additives for Polymers
EVENTS CALENDAR 24–27 April 2007 Amsterdam, The Netherlands BFR 2007 International Workshop on Brominated Flame Retardants Prof. Jacob de Boer; e-mail: [email protected]; URL: www. bfr2007.com/default.asp 24 April 2007 Bristol, UK The Plastics Industry Strategy Seminar Applied Market Information Ltd, AMI House, 45-47 Stokes Croft, Bristol BS1 3QP, UK; tel: +44-117-924-9442; fax: +44-117-989-2128; e-mail: [email protected]; URL: www. amiplastics.com 25–27 April 2007 Baltimore, MD, USA CPMA International Color Pigments Conference 2007 Color Pigments Manufacturers Association Inc, 300 North Washington St, Suite 102, Alexandria, VA 22314, USA; tel: +1-703684-4044; fax: +1-703-684-1795; e-mail: [email protected]; URL: www.pigments.org 3 May 2007 Brussels, Belgium The Plastics Industry Strategy Seminar Contact details as above 6–10 May 2007 Cincinnati, Ohio, USA ANTEC 2007 & Plastics Encounter Society of Plastics Engineers, Conference Department, 14 Fairfield Drive, PO Box 403, Brookfield, CT 06804-0403, USA; tel: +1203-775-0471; fax: +1-203-775-8490; e-mail: [email protected]; URL: www.4spe.org 22–23 May 2007 Frankfurt, Germany Blowing Agents and Foaming Processes 2007 Conference Dept, Rapra Technology, Shawbury, SY4 4NR, UK; tel: +44-1939250383; fax: +44-1939-252416; e-mail: [email protected]; URL: www.rapra.net
11
the second reading vote in Parliament on 13 December, where the compromise package was backed by more than 70% of members. Opposition from the Netherlands, Poland and particularly Germany, where a powerful lobbying exercise was led by BASF, successfully overruled the demands for mandatory substitution. The agreed deal broadly accepts that Europe’s chemicals industry can continue to use between 1500 and 2000 ‘substances of high concern’, provided that processes are ‘adequately controlled’, a principle that has long been championed by the chemical industry lobby. The revised REACH regulation now requires producers and importers to present an analysis of possible alternatives to hazardous substances. If alternatives are available, the applicants must produce ‘substitution plans’ showing how they intend to phase out the hazardous substance. If alternatives are not available, the applicants must present an R&D programme aimed at finding alternatives. In addition, it is proposed that some 17 000 existing substances produced in small quantities will be either exempted from REACH or subject to less-stringent safety data requirements. This and the new substitution plans will result in a consequent reduction in testing requirements, another area of concern. Sharing of data on animal testing will also be encouraged. A further change to benefit industry sees the length of time that commercially sensitive data should remain confidential doubling from three to six years. Finally, a contentious declaration that producers and importers have a general duty of care to prevent harm has been moved from the body of the REACH legislation to a declaratory preamble, allaying legal concerns because of differences in liability laws in EU member states. All in all, these compromises go a long way towards meeting the concerns of the chemical industry. REACH will now enter into force around June this year, with the new rules being phased in over the next 11 years. The new European Chemicals Agency (ECHA) being established in Helsinki, which will in due course handle registration applications and safety data for an estimated 30 000 widely used substances (i.e. those used or imported by a company in quantities >1 tonne/year), will become fully operational in mid-2008. It is expected to make its first series of recommendations on the most hazardous substances by mid-2009. Subscription price for one year including first class airmail delivery (12 issues): US$1343/¥159,400/1201 (Payments in other currencies are subject to our prevailing exchange rate). (Prices valid to end of 2007)
Editorial office:
Subscription enquiries, orders and payments:
Programme Editor: Steve Barrett Elsevier Limited, PO Box 150, Kidlington, Oxford OX5 1AS, UK Tel: +44 (0)1865 843239 Fax: +44 (0)1865 843971 Email: [email protected]
For customers residing in the Americas (North, South and Central America): Elsevier, Customer Support Department, PO Box 945, New York NY 10010, USA Tel: (+1) 212-633-3730 Toll Free number for North American customers: 1-888-4ES-INFO (437-4636) Fax: (+1) 212-633-3680 Email: [email protected]
For customers in the Rest of the World: Elsevier, Customer Support Dept. PO Box 211, 1000 AE Amsterdam The Netherlands Tel: (+31) 20-4853757 Fax: (+31) 20-4853432 Email: [email protected]
This journal and the individual contributions contained in it are protected under copyright by Elsevier Ltd 2007, and the following terms and conditions apply to their use: Photocopying Single photocopies of single articles may be made for personal use as allowed by national copyright laws. Permission of the publisher and payment of a fee is required for all other photocopying, including multiple or systematic copying, copying for advertising or promotional purposes, resale, and all forms of document delivery. Special rates are available for educational institutions that wish to make photocopies for non-profit educational classroom use. Permissions may be sought directly from Elsevier Rights & Permissions Department, PO Box 800, Oxford OX5 1DX, UK; phone: (+44) 1865 843830, fax: (+44) 1865 853333, e-mail: [email protected]. You may also contact Rights & Permissions directly through Elsevier's home page (http:// www.elsevier.com), selecting first 'Customer Support', then 'General Information', then 'Permissions Query Form'. In the USA, users may clear permissions and make payments through the Copyright Clearance Center, Inc, 222 Rosewood Drive, Danvers, MA 01923, USA; phone: (978) 7508400, fax: (978) 7504744, and in the UK through the Copyright Licensing Agency Rapid Clearance Service (CLARCS), 90 Tottenham Court Road, London W1P 0LP, UK; phone: (+44) 207 436 5931; fax: (+44) 207 436 3986. Other countries may have a local reprographic rights agency for payments. Derivative Works Subscribers may reproduce tables of contents or prepare lists of articles including abstracts for internal circulation within their institutions. Permission of the publisher is required for resale or distribution outside the institution. Permission of the publisher is required for all other derivative works, including compilations and translations. Electronic Storage or Usage Permission of the publisher is required to store or use electronically any material contained in this journal, including any article or part of an article. Contact the publisher at the address indicated. Except as outlined above, no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission of the publisher. Address permissions requests to: Elsevier Rights & Permissions Department, at the mail, fax and e-mail addresses noted above. Notice No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. Although all advertising material is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement of the quality or value of such product or of the claims made of it by its manufacturer. Printed by Mayfield Press, UK
02061