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REACH and paper chemicals Liisa Rapeli-Likitalo, EPCG (Ciba Specialty Chemicals Oy) European Paper Week 2005 December 1

REACH and paper chemicals Liisa Rapeli-Likitalo, EPCG (Ciba Specialty Chemicals Oy) European Paper Week 2005 December 1, 2005 Sheraton Rogier Hotel, Brussels. Paper chemicals from regulatory point of view REACH and R&D Some examples of products Future.

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REACH and paper chemicals Liisa Rapeli-Likitalo, EPCG (Ciba Specialty Chemicals Oy) European Paper Week 2005 December 1

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  1. REACH and paper chemicals Liisa Rapeli-Likitalo, EPCG (Ciba Specialty Chemicals Oy)European Paper Week 2005December 1, 2005Sheraton Rogier Hotel, Brussels

  2. Paper chemicals from regulatory point of view REACH and R&D Some examples of products Future REACH and paper chemicalsAssessment based on 1st reading of European Parliament

  3. Paper chemicals • Most are HPV–substances (> 1000 t per year) • Even special additives > 1 t per year • A number of nature based chemicals • Modified • Annex II and III – content and interpretations • Complicated reaction mixtures and poorly soluble substances • Testing • Many substances have long history of use, old test data – not under GLP • NLPs, No Longer Polymers, e.g. emulsifiers • A number of functional polymers • Many starting substances will need authorisation • Time from idea to market will be longer • Paper machines are sensible for changes in products • A number of customized products

  4. R&D - Pulp and paper chemicals • Many additives and process chemicals, e.g. • Solvents • Initiators, catalysts • Chain transfer agents • Emulsifiers, surface active agents • Antioxidants • Plasticizers • Stabilizers • Release agents • pH Regulators • Stripping chemicals • Defoamers • Biocides

  5. REACH – Something to gain • R&D and PPORD • Longer than current PORD  5+10 years • Only one application dossier, not separately in every MS: • Agency • Same fee and equal opportunity • Volume versus application • Categories and read across • Possibility to play around the molecules and find/use ”new” molecules without full testing dossier • Annex II? • Practice? • More data publicly available • Learning from each other?

  6. REACH – Concerns for paper chemicals • List of available chemicals will be shorter than today • EINECS: 100 116 entries • ELINCS: ~5000 • + NLP:s, No Longer Polymers • Future: ~ 30 000 +/- xxxx? • Practice • Interpretations • Annex II and III • Exposure based waiving… • OSOR • Workability

  7. REACH – Concerns for paper chemicals • Chemical Safety Assessment and Chemical Safety Report (>1 t/y) • Risk Management Measures included • Covers also marine environment • Exposure scenarios • Paper making and recycling • Exposure and use categories • Communication in safety data sheets • Authorisation may require a lot of resources • Substitution and research in order to find alternatives => ”Defensive R&D” • Socio Economic Analysis / Methodology • Time limited (5 years) • Can be opened by third party intervention • Many monomers and other starting substances for polymers used by paper industry will require authorisation • e.g. acrylamide, acrylonitrile, butadiene, epichlorohydrin…

  8. How to find alternative substances? • Active structural groups = reactive groups • Other approval processes may take years to complete, e.g. food contact compliance • Substances with long history of use are known • Test results, exposure data exist • Technical performance known • Availability • Production processes and facilities • Raw materials • Reasonable price

  9. How to find alternative substances? • Possible change in the composition of paper chemicals => • Literature & desktop research • Laboratory trials • Pilot trials • Production trials • Application trials: by the producer of the chemical + customer pilots • Mill trials • Easily a couple of years and yyy yyy € or y yyy yyy €

  10. REACH requires resources • All functions of a company will be effected • Purchasing • R&D, e.g. laboratories • Substance identity, impurities, side reaction products etc. • Physico chemical properties • Registration and authorisation dossier and CSR • Different uses • Dosage, content/residues in intermediates and final products, exposure measurements • Emission/Effluent measurements • Air, water, waste water treatment plants (including sludge), soil, sediment • Recycling and disposal… • R&D in future more defensive than real R&D • Production • Sales • Administration • ”REACH Competence Centers” (including ”office chemists”) • IT…

  11. REACH AND PAPER CHEMICALS - Examples • Styrene acrylate based polymeric size • Polymers exempted from REACH for the time being but new Safety Data Sheets, SDSs for the products have to be prepared • Monomers and other starting substances have to be registered, HPV chemicals => Chemicals Safety Report, CSR and new SDSs • Own production and importation but EU-RA, ICCA Initiative and EPA HPV program data exist for main monomers • Specific monomers, initiators, emulsifiers, pH regulators, defoamers etc. • Make sure that they will be available, PBT or vPvB… or prepare for defensive R&D • Possible data gaps… • Food contact approvals exist => this use is exempted from CSR • Styrene possible endocrine disruptor - authorisation?

  12. PAPER CHEMICAL EXAMPLES • Calcium distearate • Annex II – pure! • Annex II: ”Substances commonly found in foodstuffs, such as citric acid, sugar, oils, fatty acids, etc.” • Adipic acid (E 355), citric acid (E 330) • Casein? • Fatty acids and their derivatives as deinking chemicals?

  13. REACH & paper chemicals • Details and interpretations still open • Basic volume chemicals - bulk • No remarkable changes foreseen yet • Some additives may be ”lost” which may cause additional workload and cost effects • Specialty chemicals • Some pressure on further testing • Long term effects • Testing problems • Substitution is very difficult

  14. REACH - Cooperation of mills and chemicals’ suppliers Management of chemical know how • ERP systems • Data per substance versus products • Communication • Questionnaires and safety data sheets Registration, evaluation and authorisation • Substance information: Suppliers! • Chemical Safety Reports • Help from customers will be needed • Exposure scenarios • Compare to current EU Risk Assessment

  15. REACH – Future • Resources? • Prices • New type of business with • REACH compliant chemicals • IPR • Data ownership • Registration and authorisation dossiers and numbers But paper will be made and paper chemicals will be manufactured and developed even when REACH is in force…

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